biotecMAX™ January/ February/March/April 2021 Insight

KEYTRUDA® (pembrolizumab)

Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery

April 8, 2021 6:45 am ET

Phase 3 Data from KEYNOTE-564 to be Presented at Upcoming Medical Meeting and Submitted to Regulatory Authorities

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

“Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These new data are the result of our research to evaluate the role of KEYTRUDA in helping patients with earlier stages of disease and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma. We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”

KEYTRUDA is currently approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC. Merck is continuing to study KEYTRUDA as monotherapy and in combination with other cancer treatments across multiple settings and stages of RCC through its broad clinical program.

About KEYNOTE-564

KEYNOTE-564 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03142334 ) evaluating KEYTRUDA monotherapy for the adjuvant treatment of patients with RCC who have undergone nephrectomy and who have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) RCC with clear cell component. The study enrolled 950 patients who were randomized to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 17 cycles) or placebo (saline solution IV on Day 1 of each three-week cycle for up to 17 cycles). The primary endpoint is DFS, and the secondary endpoints include OS and safety.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

in combination with platinum- and fluoropyrimidine-based chemotherapy, or
as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD L1 (CPS ≥10) as determined by an FDA approved test

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

https://www.keytruda.com/

For more information, visit www.merck.com

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

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Merck’s Keytruda succeeds in late-stage trial as monotherapy in kidney cancer

Apr. 08, 2021 2:00 PM ETMerck & Co., Inc. (MRK)By: Dulan Lokuwithana, SA News Editor7 Comments

Merck (MRK -0.3%) says that its anti-PD-1 therapy Keytruda reached the primary endpoint of disease-free survival (“DFS”) in a pivotal Phase 3 trial as a potential adjuvant treatment of a specific category of patients with renal cell carcinoma (“RCC”).
https://seekingalpha.com/news/3680476-mercks-keytruda-succeeds-in-late-stage-trial-as-monotherapy-in-kidney-cancer
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A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER IT’S TRU. KEYTRUDA. SELECT A TYPE OF CANCER Search by cancer type or name Advanced non–small cell lung cancer Melanoma Head and neck squamous cell cancer High-risk non-muscle invasive bladder cancer (NMIBC) Advanced urothelial bladder cancer Advanced kidney cancer (RCC) Advanced MSI-H/dMMR colorectal cancer Microsatellite instability-high cancer (MSI-H/dMMR) Advanced triple-negative breast cancer (TNBC) Classical Hodgkin lymphoma (cHL) Advanced gastric cancer Advanced cervical cancer Primary mediastinal B‑cell lymphoma (PMBCL) Advanced liver cancer (HCC) Advanced Merkel cell carcinoma Advanced esophageal squamous cell carcinoma Cutaneous squamous cell carcinoma (cSCC)

XIENCE™ STENT

ABBOTT'S XIENCE™ STENT RECEIVES EUROPEAN APPROVAL FOR ONE-MONTH DUAL ANTI-PLATELET THERAPY (DAPT) FOR HIGH BLEEDING RISK PATIENTS- New shorter duration of dual anti-platelet therapy (DAPT) post XIENCE stent implant provides physicians with additional options to treat patients at high risk of bleeding- XIENCE is the most used drug eluting stent in the world, and European approval for shorter DAPT is supported by two studies that demonstrated safe treatment of stented patients with one-month or three-month use of DAPT- Recent data demonstrate XIENCE with short DAPT does not increase cardiac events and reduces severe bleeding, further confirming the leading safety profile of the XIENCE stent

Photos(1)

ABBOTT PARK, Ill., April 6, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) today announced its XIENCE stent has received CE Mark in Europe for shorter duration of dual anti-platelet therapy (DAPT) – as short as 28 days, the shortest indication available in the world – for patients with high bleeding risk (HBR). The approval follows recent results from two studies that demonstrated both one-month or three-month DAPT followed by aspirin monotherapy is safe in HBR patients and is intended to improve patient outcomes and provide physicians more options to treat their patients. XIENCE is the most widely used stent worldwide and is the only stent to have evidence and data for both one-month and three-months DAPT followed by two different types of blood-thinning medication in HBR patients.

Patients who receive stents are typically on DAPT regimens (aspirin and antiplatelet drugs known as P2Y12 inhibitors to prevent blood clots) for six to 12 months to support vessel healing and prevent clotting from blocking the stented vessel. However, HBR patients can experience side effects such as bleeding during prolonged courses of DAPT. Abbott's XIENCE 28 and XIENCE 901 studies show that DAPT can be safely discontinued early – as short as 28 days – with no increased risk in patient adverse events, further confirming the industry-leading safety profile of the XIENCE stent.

"The results of the studies examining the XIENCE stent in high bleeding risk patients with shorter durations of dual anti-platelet therapy were highly consistent – with no increase in cardiac events and significant reduction in severe bleeding. To see such consistency is important for physicians seeking the best possible outcome for our patients," says Marco Valgimigli, M.D., Ph.D., deputy chief of CardioCentro Ticino, Lugano, Switzerland and professor of cardiology at the University of the Italian Switzerland (USI).

Connect with us at www.abbott.com

Abbott's XIENCE stent indication gets European approval

Apr. 06, 2021 9:21 AM ETAbbott Laboratories (ABT)By: Aakash Babu, SA News Editor2 Comments

Abbott (NYSE:ABT) announces that its XIENCE stent has received CE Mark in Europe for shorter duration of dual anti-platelet therapy (DAPT) – as short as 28 days, the shortest indication available in the world – for patients with high bleeding risk (HBR).
https://seekingalpha.com/news/3679499-abbotts-xience-stent-indication-gets-european-approval
https://seekingalpha.com/symbol/ABT
https://www.cardiovascular.abbott/int/en/hcp/products/percutaneous-coronary-intervention/xience-family/xience-trial-results.html

XIENCE 28 showed that XIENCE™ Stent with 1-month DAPT had no increase in ischemic events and a significantly lower rate of severe bleeding (BARC 3-5) compared with 6-month DAPT. These data were used to support the CE Mark for a 1-month DAPT indication in High Bleeding Risk Patients.

Tisotumab Vedotin

Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

04/09/2021

- FDA Action Date is October 10, 2021 -

- BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 -

BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.1

“The FDA’s filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”

About the innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.1 Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator’s choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.

For more information on our marketed products and robust pipeline, visit www.seagen.com

For more information, please visit Genmab.com.

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FDA accepts Genmab, Seagen's tisotumab vedotin BLA application for review

Apr. 09, 2021 4:14 PM ETSeagen Inc. (SGEN)By: Aakash Babu, SA News Editor

Genmab A/S (OTCPK:GNMSF) and Seagen (NASDAQ:SGEN) announces that the U.S. FDA has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin.
https://seekingalpha.com/news/3680798-fda-accepts-genmab-seagens-tisotumab-vedotin-bla-application-for-review
https://seekingalpha.com/symbol/GNMSF
https://seekingalpha.com/symbol/SGEN

A Trial of Tisotumab Vedotin in Cervical Cancer

OPDIVO® (nivolumab) Plus Chemotherapy

Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

04/10/2021CATEGORY:

Corporate/Financial News

Nearly a quarter of patients who received Opdivo plus chemotherapy showed no evidence of cancer cells in tissue removed during surgery vs. 2.2% of patients who received chemotherapy alone

Opdivo-based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease.

CheckMate -816 represents the first randomized Phase 3 study to show a significant improvement in pathological response with a neoadjuvant immunotherapy combination in patients with resectable NSCLC. The first disclosure of these data will be featured in an oral presentation during the Clinical Trials Plenary Session (Abstract #5218) at the American Association for Cancer Research (AACR) Annual Meeting 2021 on Saturday, April 10, 2021 from 12:30-12:45 p.m. EDT.

“The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients. Unfortunately, even when patients with resectable non-small cell lung cancer undergo surgery, the cancer returns in more than half of patients, and many then die from their disease,” said Nicolas Girard, M.D., professor and head of department, medical oncology, Institut Curie. “The pathologic complete response data from CheckMate -816 give us an early indication of the potential benefit of adding nivolumab to chemotherapy as a neoadjuvant treatment in resectable non-small cell lung cancer, and we hope that these encouraging results eventually translate into improved event-free survival and overall survival for these patients.”

Opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (MPR). Four times as many patients treated with Opdivo plus chemotherapy vs. chemotherapy alone achieved MPR (36.9% vs 8.9%; OR 5.70, 95% CI: 3.16-10.26), meaning 10% or less of their tumor cells remained after neoadjuvant therapy.

About CheckMate -816

CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three doses, or platinum doublet chemotherapy every three weeks for three doses, followed by surgery. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival (EFS). Key secondary endpoints include overall survival (OS), major pathologic response (MPR) and time to death or distant metastases.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

Indications

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

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https://www.opdivo.com/

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer BACK ADVANCED LUNG CANCER NON-SMALL CELL LUNG CANCER OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1 OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer OPDIVO for people who have had prior treatments for non-small cell lung cancer Choose your condition: Advanced Lung Cancer Advanced Kidney Cancer Advanced Liver Cancer Colorectal Cancer (MSI-H/dMMR) Advanced Esophageal Squamous Cell Cancer Melanoma Head and Neck Squamous Cell Cancer Advanced Bladder Cancer Classical Hodgkin Lymphoma Malignant Pleural Mesothelioma

TYSABRI® (NATALIZUMAB)

THE EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR NEW SUBCUTANEOUS ADMINISTRATION OF TYSABRI® (NATALIZUMAB) TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS

April 7, 2021 at 7:30 AM EDT

TYSABRI is a well-established high-efficacy treatment that now provides two routes of administration enabling flexibility to meet patients' individual preferences and needs
The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians beyond the infusion setting
The approval adds to Biogen’s strong MS portfolio and is part of its leading, innovative work to improve the understanding of optimal clinical outcomes as part of the long-term treatment of patients with MS

CAMBRIDGE, Mass., April 07, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). The new route of administration offers comparable efficacy and safety to the TYSABRI intravenous (IV) formulation building on the therapy’s long-term data, established clinical benefits and well-characterized safety profile. TYSABRI is the only high-efficacy MS therapy to offer two routes of administration options providing patients and physicians the flexibility to choose the one that best fits their individual needs.

The SC and IV formulations of TYSABRI are dosed 300 mg, every four weeks (Q4W) by a healthcare provider. The SC option expands the clinical settings, beyond infusion centers, where patients can be treated. In addition, the SC formulation is administered in a shorter timeframe compared to the IV formulation and allows physicians to reduce or remove the post-dose observation period for some patients after six doses as clinically appropriate. The addition of the SC administration also offers people living with MS another option at a time when they are being encouraged to discuss considerations around COVID-19 vaccination and their MS treatment with their physicians.1,2

TYSABRI® (NATALIZUMAB)

https://www.tysabri.com/

Approved by the EC in 2006, TYSABRI’s efficacy and safety have been shown through clinical trials and extensive real-world evidence gathered over nearly 15 years. During that time, Biogen has initiated research, through efforts such as the MS PATHS network and TYSABRI Observational program (TOP), that have broadened the clinical data for TYSABRI providing physicians and patients with more information on this established high-efficacy MS therapy with a well-characterized safety profile.

About TYSABRI® (natalizumab)
TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. In the European Union, it is indicated as a single disease modifying treatment (DMT) in adults with highly active relapsing-remitting MS (RRMS) for patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. In the U.S., TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. TYSABRI is approved in 80 countries, and approximately 213,000 people worldwide have been treated with TYSABRI, with over 835,000 patient-years of experience, based on clinical trials and prescription data.5

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.

TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), a decrease in lymphocyte counts and infections, including opportunistic and other atypical infections.

For information on TYSABRI prescribing information in the EU, please visit: https://ec.europa.eu/health/documents/community-register/html/h346.htm. Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website.

To learn more, please visit www.biogen.com

Biogen's TYSABRI wins EC approval for multiple sclerosis indication

Apr. 07, 2021 7:41 AM ETBiogen Inc. (BIIB)By: Aakash Babu, SA News Editor1 Comment

Biogen (NASDAQ:BIIB) announces that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).
https://seekingalpha.com/news/3679768-biogens-tysabri-wins-ec-approval-for-multiple-sclerosis-indication
https://seekingalpha.com/symbol/BIIB
https://www.tysabri.com/

What is TYSABRI? TYSABRI is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML). When starting and continuing treatment with TYSABRI, it is important to discuss with your doctor whether the expected benefit of TYSABRI is enough to outweigh this risk. It is not known if TYSABRI is safe and effective in children under 18 years of age.

RINVOQTM (upadacitinib)

April 2, 2021

AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis

NORTH CHICAGO, Ill., April 2, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

As previously disclosed, AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis. AbbVie responded to the request and the FDA has informed AbbVie that, as expected, it requires additional time for a full review of the submission.

"We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients living with moderate to severe atopic dermatitis in need of new treatment options," said Michael Severino, M.D., vice chairman and president, AbbVie.

About RINVOQTM (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.

https://www.rinvoq.com/

For more information about AbbVie, please visit us at www.abbvie.com.

FDA extends review of Abbvie's sNDA for Rinvoq in atopic dermatitis

Apr. 02, 2021 10:51 PM ET AbbVie Inc. (ABBV) By: Jonathan M Block, SA News Editor13 Comments

The FDA is extending the PDUFA data for Abbvie's (NYSE:ABBV) sNDA for the JAK inhibitor Rinvoq (upadacitinib) in moderate to severe atopic dermatitis by three months to Q3 2021.
https://seekingalpha.com/news/3678991-fda-extends-review-of-abbvie-snda-for-rinvoq-in--atopic-dermatitis
https://seekingalpha.com/symbol/ABBV
https://www.abbvie.com/

USE RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

TRODELVY™ (sacituzumab govitecan-hziy)

April 07, 2021

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

– Trodelvy Significantly Reduced the Risk of Death by 49% Compared with Single-Agent Chemotherapy in the Phase 3 ASCENT Study –

– Trodelvy is Under Regulatory Review in the EU and in the United Kingdom, Canada, Switzerland and Australia as Part of Project Orbis –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study. Today’s approval expands the previous Trodelvy indication to include treatment in adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy (sacituzumab govitecan-hziy)

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including metastatic triple-negative breast cancer (TNBC), where high expression is associated with poor survival and relapse.

Trodelvy is also being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

https://trodelvy.com/

About the ASCENT Study

The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer (TNBC) who had received two or more prior systemic therapies (including a taxane), at least one of them for metastatic disease. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary efficacy outcome was progression-free survival (PFS) in patients without brain metastases at baseline, as measured by a blinded, independent, centralized review using RECIST v1.1 criteria. Additional efficacy measures included PFS for the full population (all patients with and without brain metastases) and overall survival (OS). More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

Please see full Prescribing Information, including BOXED WARNING.

U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.

Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210407006027/en/

Gilead wins full FDA approval for Trodelvy in triple-negative breast cancer

Apr. 08, 2021 7:35 AM ETGilead Sciences, Inc. (GILD)By: Dulan Lokuwithana, SA News Editor4 Comments

Gilead Sciences (NASDAQ:GILD) has announced that the FDA has granted the full approval for Trodelvy (sacituzumab govitecan-hziy) to treat a certain category of adult patients with unresectable locally advanced or metastatic triple-negative breast https://seekingalpha.com/news/3680249-gilead-wins-full-fda-approval-for-trodelvy-in-triple-negative-breast-cancercancer (“TNBC”).
https://seekingalpha.com/symbol/GILD
https://trodelvy.com/

WHAT IS TRODELVY? TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease. TRODELVY is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

XB002

Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid TumorsPDF Version

– Promising preclinical data suggest best-in-class potential for XB002, a next-generation tissue factor-targeting antibody-drug conjugate –

– Phase 1 clinical trial expected to begin in Q2 2021 –

ALAMEDA, Calif.--(BUSINESS WIRE)--Apr. 5, 2021-- Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors. As a next-generation tissue factor-targeting antibody-drug conjugate (ADC), XB002 has the potential for an improved therapeutic index and may provide a favorable safety profile compared with earlier-generation tissue factor-targeting ADCs.

“The acceptance of our Investigational New Drug Application for XB002 gets us one step closer to our first biologic entering the clinic and learning more about its potential to help patients with difficult-to-treat cancers,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “Considering XB002’s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our phase 1 trial in patients with advanced solid tumors.”

XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. XB002 is a rationally designed next-generation ADC that leverages proprietary linker-payload technology.

Preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class. The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs. XB002 has shown significant tumor growth inhibition and, in some cases, complete regression. The rational design and preclinical profile of this novel tissue factor-targeting ADC suggest that, if born out in clinical evaluation, XB002 could have an improved therapeutic index and favorable safety profile compared with earlier tissue factor-targeting ADCs.

For more information about Exelixis, please visit www.exelixis.com

FDA accepts Exelixis' XB002 application in advanced solid tumors

Apr. 05, 2021 8:35 AM ETExelixis, Inc. (EXEL)By: Mamta Mayani, SA News Editor

The FDA has accepted Exelixis' (NASDAQ:EXEL) Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors.
https://seekingalpha.com/news/3679096-fda-accepts-exelixis-xb002-application-in-advanced-solid-tumors
https://seekingalpha.com/symbol/EXEL
https://www.exelixis.com/pipeline/

Unlocking Transformative Cancer Therapies Our pipeline includes the Exelixis-discovered compounds, cabozantinib, cobimetinib and XL092, as well as other programs that are the subject of partnerships and collaborations with several biopharmaceutical companies. Safety and efficacy for these compounds in the unapproved uses or indications described below have not yet been established.

Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone

FDA approves Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma

- Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies- While the median progression free survival (PFS) for Sarclisa combination therapy is not yet reached, consistent improvement in PFS is seen across patient subgroups- This is the second FDA approval for Sarclisa in combination with standard of care backbone therapies

PARIS, March 31, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.

"In the Phase 3 IKEMA study, the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%," said Thomas G. Martin, M.D., Associate Director, Myeloma Program, The University of California, San Francisco, Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center. "This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma."

This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

"Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor," said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. "With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today's milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma."

Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

This marks the second FDA approval for Sarclisa since March 2020 and comes more than three months ahead of the FDA's target action date. In February, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for a second indication for Sarclisa, in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The use of Sarclisa in combination with Kd is not currently approved in the European Union (EU), but the final decision whether to expand the indication is expected from the European Commission in the coming months. In Europe, Sarclisa is indicated in combination with pom-dex for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Outside of the U.S. and the EU, Sarclisa is approved in Switzerland, Canada, Australia, Japan, Russia, the UAE, South Korea, Taiwan and Brazil in combination with pom-dex for the treatment of certain adults with RRMM.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard and novel treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The use of Sarclisa in these additional settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is SARCLISA?

SARCLISA is a prescription medicine used in combination with:

The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.

It is not known if SARCLISA is safe and effective in children.

https://www.sarclisa.com/

Do not receive SARCLISA if you have a history of a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in the full Prescribing Information).

FDA approves Sanofi's Sarclisa for another multiple myeloma indication

Mar. 31, 2021 5:39 PM ET Sanofi (SNY) By: Jonathan M Block, SA News Editor1 Comment

The FDA has approved Sanofi's (NASDAQ:SNY) Sarclisa (isatuximab) for relapsed or refractory multiple myeloma (RRMM) in combination with Kyprolis (carfilzomib) and dexamethasone.
https://seekingalpha.com/news/3678341-fda-approves-sanofis-sarclisa-for-another-multiple-myeloma-indication
htthttps://www.sarclisa.com/ps://seekingalpha.com/symbol/SNY
https://www.sanofi.us/en/

What is SARCLISA? SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma. It is not known if SARCLISA is safe and effective in children.

VIR-7831

Vir Biotechnology Announces New Preclinical Research Demonstrating VIR-7831 Maintains Neutralizing Activity Against the SARS-CoV-2 California Variant

04/05/21 at 8:00 AM EDTPDF Version

– Data add to growing body of pre-clinical evidence demonstrating that VIR-7831 maintains activity against all known circulating variants of concern –

– Plasma from vaccinated individuals and several therapeutic monoclonal antibodies showed a reduction in neutralization potency against the California variant –

SAN FRANCISCO, April 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429). Study results also demonstrate that the L452R mutation reduced both the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs. Data were published on April 1, 2021 on bioRxiv, and have been submitted to a peer-reviewed journal for future print publication.

In this new study, researchers at Vir and the University of Washington, report the rapid and exponentially increasing spread of the California variant throughout all 50 states and in 29 additional countries worldwide, and characterize the impact of its three mutations: S13I and W152C in the NTD and L452R in the RBD.

VIR-7831

VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration or any other regulatory authority.

About VIR-7831
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

Data from 43 vaccinated donors and nine convalescent donors demonstrated that, in a pseudotyped virus system, the S13I, W152C and L452R mutations reduced the neutralization potency of plasma by three-to-six-fold. In addition, the L452R mutation reduced the neutralization activity of 14 out of 35 RBD-specific mAbs, including three clinical-stage antibodies. Researchers also observed a complete loss of neutralization by all NTD-specific mAbs that is mediated by an unconventional escape mechanism. VIR-7831, which targets a non-receptor binding motif (RBM) epitope, was unaffected by the L452R mutation.

“The rapid increase in frequency of this variant in California and neighboring states and its ability to confer some degree of resistance to vaccines and antibody therapies is concerning,” said David Veesler, Ph.D., associate professor of biochemistry, University of Washington in Seattle. “The reduced sensitivity of this variant to plasma antibodies results from three individual spike mutations that mediate evasion from both RBD (partial) and NTD (total) specific antibodies. Together, these data demonstrate that if we are to combat current and anticipated future variants, there is a critical need for monoclonal antibodies that target invariant regions of the spike protein with the potential for a high barrier to resistance.”

“These data add to the growing body of evidence supporting our rationale for targeting a non-RBM epitope and the potential of VIR-7831 to combat the current variants of concern, including the evasive California variant, either as monotherapy or as a foundational therapy for future combinations,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. “We believe VIR-7831 could significantly impact both the trajectory of the pandemic and the outcomes of patients facing the more dire consequences of COVID-19. We look forward to continuing to work with global regulatory authorities to bring VIR-7831 to patients as quickly as possible.”

For more information, please visit www.vir.bio.

Vir Biotechnology posts new preclinical research of VIR-7831 in SARS-CoV-2

Apr. 05, 2021 8:31 AM ETVir Biotechnology, Inc. (VIR)By: Aakash Babu, SA News Editor

Vir Biotechnology (NASDAQ:VIR) announces new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2.
https://seekingalpha.com/news/3679092-vir-biotechnology-posts-new-preclinical-research-of-vir-7831-in-sars-cov-2
https://seekingalpha.com/symbol/VIR
https://www.vir.bio/pipeline/#focus

Chronic and acute infections impact hundreds of millions of people every year. We are taking aim at some of the world’s largest and most serious infectious diseases, infections that are evasive, challenging, or insufficiently addressed by current approaches including hepatitis B, influenza A, SARS-CoV-2, HIV, and tuberculosis.

AbCellera and Gilead ink new multi-year antibody discovery collaboration

AbCellera and Gilead Sciences Announce New Multi-Year, Multi-Target Antibody Discovery Collaboration

Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera’s entire technology stack, including the Trianni Mouse® and the OrthoMab bispecific platforms

APRIL 1, 2021

VANCOUVER, British Columbia - AbCellera (Nasdaq: ABCL) today announced agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera’s humanized mouse technology, the Trianni Mouse®. Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.

Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera’s technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse® platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

“We are excited to build on the success of the first program and deepen our relationship with the team at Gilead,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “We are particularly pleased to see the value created for our partners by quickly integrating the Trianni Mouse® and OrthoMabTM platforms, which we acquired in second half of 2020.”

AbCellera’s partners benefit from an operating system designed to support many antibody modalities, unlock new targets, and increase the speed and the probability of success of their therapeutic antibody discovery programs. AbCellera’s AI-powered technology stack brings together microfluidics, single cell analysis, machine learning, computation, custom robotics, and automation to compound the power of each step in the discovery process.

About AbCellera Biologics Inc.

AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com.

AbCellera and Gilead ink new multi-year antibody discovery collaboration

Apr. 01, 2021 9:32 AM ET AbCellera Biologics Inc. (ABCL)

By: Aakash Babu, SA News Editor5 Comments

AbCellera (ABCL +3.1%) announces agreements to expand its collaboration with Gilead Sciences including a multi-year, multi-target antibody discovery collaboration and access to the company's humanized mouse technology, the Trianni Mouse.
https://seekingalpha.com/news/3678573-abcellera-and-gilead-inks-new-multi-year-antibody-discovery-collaboration
https://seekingalpha.com/symbol/ABCL
https://seekingalpha.com/symbol/GILD

FULL-STACK AI-POWERED ANTIBODY DISCOVERY PLATFORM.

Tecartus®

April 01, 2021

Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

-- If Approved, Tecartus Would Be the First and Only CAR T-Cell Therapy Approved for Adult Patients (18 Years and Older) with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The sBLA is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress.

In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (≥18 years old) with relapsed or refractory ALL.

Tecartus®

About ZUMA-3

ZUMA-3 is an ongoing international multicenter, registrational Phase 1/2 study in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of Tecartus in this patient population.

About Tecartus

Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. In addition to adult ALL, Tecartus is also currently being evaluated in a Phase 1/2 trial in chronic lymphocytic leukemia (CLL) and pediatric ALL. The use of Tecartus in adult ALL, pediatric ALL and CLL is investigational, and its safety and efficacy have not been established in these cancer types.

Tecartus Indication

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

For more information on Kite, please visit www.kitepharma.com.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at www.kitepharma.com and www.gilead.com.

Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210401

https://www.tecartus.com/

Gilead submits sBLA for Tecartus for acute lymphoblastic leukemia

Apr. 01, 2021 4:49 PM ET Gilead Sciences, Inc. (GILD) By: Jonathan M Block, SA News Editor8 Comments

Kite, a Gilead (NASDAQ:GILD) company, has submitted an sBLA to the FDA for Tecartus (brexucabtagene autoleucel) as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
https://seekingalpha.com/news/3678871-gilead-submits-sbla-for-tecartus-for-acute-lymphoblastic-leukemia
https://seekingalpha.com/symbol/GILD

OUR PIPELINE

LEADING THE WAY IN CELL THERAPY

Our pipeline of cancer therapies in the areas of cell therapy, immuno-oncology, and targeted therapies includes investigational therapies and next-generation technologies that have the power to transform the way cancer is treated. As we look to the future, we remain focused on advancing technologies that could someday address additional hematological malignancies and solid tumors.

https://www.kitepharma.com/science-medicine/pipeline

APPROVED USE TECARTUS is a treatment for your mantle cell lymphoma. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

biotecMAX™ January/ February/March 2021 Insight

COVID-19 vaccine BNT162b2

PFIZER-BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS OF PIVOTAL COVID-19 VACCINE STUDY IN ADOLESCENTS

Wednesday, March 31, 2021 - 06:45am

In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated
The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2
The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase 3 trial in 2,260 adolescents.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210331005503/en/

COVID-19 vaccine BNT162b2

About the Phase 3 Data from Adolescents 12-15 Years of Age

The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.

The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY® to expand use in adolescents 12-15 years of age as quickly as possible. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.

AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

For more information, please visit www.BioNTech.de

In addition, to learn more, please visit us on www.Pfizer.com

Pfizer/BioNTech report positive data for COVID-19 shot in adolescents

Mar. 31, 2021 7:18 AM ET Pfizer Inc. (PFE) By: Dulan Lokuwithana, SA News Editor11 Comments

Announcing top-line results from a Phase 3 trial in adolescents 12 to 15 years of age, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) said that its COVID-19 vaccine led to 100% efficacy and robust antibody responses exceeding the level recorded in an earlier analysis of 16–25-year-old participants.
https://seekingalpha.com/news/3677958-pfizerbiontech-report-positive-data-for-covid-19-shot-in-adolescents
https://seekingalpha.com/symbol/BNTX
https://seekingalpha.com/symbol/PFE

The Pfizer-BioNTech COVID-19 Vaccine Was Granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked soone

https://www.cvdvaccine-us.com/

Pfizer Vaccine Gives 100% Protection at Ages 12-15 in Study

The finding could pave the way for shots for teens and pre-teens before the next school year.

Pfizer-BioNTech Vaccine Said to Be Powerfully Protective in Adolescents

A clinical trial found no infections among vaccinated children ages 12 to 15, the companies said, and there were no serious side effects.

BioNTech-Pfizer vaccine shows '100% efficacy' for young teens

New clinical trial data shows "topline results" for kids between 12 to 15-years-old, Pfizer and BioNTech said. Vaccinating children will be crucial for stopping the pandemic and helping schools look more normal.

https://www.dw.com/en/covid-biontech-pfizer-vaccine-shows-100-efficacy-for-young-teens/a-57061878

Pfizer Shot Remains More Than 91% Effective After Six Months

Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study

The Pfizer-BioNTech COVID-19 Vaccine Was Granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked soone

XOSPATA® (gilteritinib)

Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -

TOKYO, March 29, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis.

COMMODORE is an open-label, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China and other countries. Astellas has stopped enrollment in the trial and patients in the chemotherapy arm will be offered the opportunity to receive gilteritinib.

About the COMMODORE Trial
The Phase 3 COMMODORE trial (NCT03182244) is an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China, as well as in other countries. The primary endpoint of the trial is OS. The study also evaluated safety and determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of gilteritinib compared to salvage chemotherapy. Subjects were randomized in a 1:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.8

About the ADMIRAL Trial
The Phase 3 ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3mut+ who are refractory to or have relapsed after first-line AML therapy. The co-primary endpoints of the trial were OS and CR/CRh rates; OS was the primary endpoint at the trial's final analysis. The study enrolled 371 patients with relapsed or refractory AML and FLT3mut+ present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.9

About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib is available as XOSPATA® in the U.S., Japan and selected European countries, among others, for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.10 Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high burden and poor prognosis, and FLT3-TKD mutations.11

https://xospata.com/

For more information, please visit our website at https://www.astellas.com/en.

Astellas' Xospata meets overall survival endpoint in late-stage blood cancer study

Mar. 30, 2021 6:01 AM ET Astellas Pharma Inc. (ALPMF) By: Mamta Mayani, SA News Editor

Astellas Pharma (OTCPK:ALPMF) announces that a Phase 3 confirmatory trial of Xospata (gilteritinib) in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis.
https://seekingalpha.com/news/3677449-astellas-xospata-meets-primary-endpoint-in-late-stage-blood-cancer-https://seekingalpha.com/symbol/ALPMFstudy

WHAT IS XOSPATA XOSPATA is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation when the disease has come back or has not improved after previous treatment(s). Your healthcare provider will perform a test to make sure XOSPATA is right for you. It is not known if XOSPATA is safe and effective in children.

EYLEA® (AFLIBERCEPT) INJECTION

March 30, 2021 at 7:04 PM EDT Back

NIH-SPONSORED TRIAL FINDS EYLEA® (AFLIBERCEPT) INJECTION REDUCED VISION-THREATENING COMPLICATIONS BY 68% AFTER TWO YEARS IN DIABETIC RETINOPATHY PATIENTS

TARRYTOWN, N.Y., March 30, 2021 /PRNewswire/ --

Protocol W trial data confirm results from PANORAMA trial showing EYLEA significantly reduced vision-threatening complications and improved anatomic measures of diabetic retinopathy

Although patients' overall vision was similar in the EYLEA and sham groups at two years in Protocol W, a new analysis from PANORAMA shows that delaying EYLEA treatment (sham group) was associated with prolonged periods of vision loss

Two diabetic retinopathy trials (Protocol W and PANORAMA) have now shown the benefit of EYLEA every 16 weeks following an initial dosing period; Regeneron to discuss 16-week dosing interval with U.S. FDA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced JAMA Ophthalmology has published initial results from the National Institutes of Health-sponsored Protocol W trial assessing EYLEA® (aflibercept) Injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME). At two years, the primary outcome of the trial showed a 68% reduced risk of developing vision-threatening complications (either proliferative diabetic retinopathy [PDR] or CI-DME with vision loss) in patients who received the EYLEA every-16-weeks dosing regimen. In comparison, patients receiving sham injections were almost five times more likely to experience disease progression requiring EYLEA rescue therapy.

EYLEA® (AFLIBERCEPT) INJECTION

About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.

https://eylea.us/

About Protocol W
Protocol W is a four-year, randomized, multi-center, controlled Phase 3 trial (n=399 eyes) designed to determine the efficacy of EYLEA compared to sham in preventing vision-threatening complications in high risk patients. The primary outcome at two years was time to development of CI-DME with vision loss or PDR. Key secondary outcomes included development of any PDR or DME criteria based on reading center assessment, as well as development of CI-DME with a ≥10% and ≥25 micron increase in center subfield thickness. Per the trial protocol, Protocol W will continue for another two years, when the second primary outcome will assess visual acuity outcomes between the two groups at four years.

The Clinicaltrials.gov identifier for this trial is NCT02634333. The trial was supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with funding through the Special Diabetes Program, through a cooperative agreement (EY14231).

INDICATIONS
EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

For additional information about the company, please visit www.regeneron.com

Please see the full Prescribing Information for EYLEA.

View original content:http://www.prnewswire.com/news-releases/nih-sponsored-trial-finds-eylea-aflibercept-injection-reduced-vision-threatening-complications-by-68-after-two-years-in-diabetic-retinopathy-patients-301259081.html

SOURCE Regeneron Pharmaceuticals, Inc.

Regeneron's Eylea reduces vision loss by 68% after two years in diabetic retinopathy

Mar. 31, 2021 3:58 AM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Mamta Mayani, SA News Editor

JAMA Ophthalmology has published initial results from Protocol W trial assessing Regeneron Pharmaceuticals' (NASDAQ:REGN) EYLEA (aflibercept) Injection in patients with non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME).
https://seekingalpha.com/news/3677905-regenerons-eylea-reduces-vision-loss-by-68-after-two-years-in-diabetic-retinopathy
https://seekingalpha.com/symbol/REGN
https://eylea.us/

INDICATIONS EYLEA® (aflibercept) Injection 2 mg (0.05mL) is a prescription medicine approved for the treatment of patients with Wet Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Please see the full Prescribing Information for EYLEA.

QINLOCK® (Ripretinib)

China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)

March 31, 2021 at 4:57 AM EDTPDF Version

China NMPA approval follows 2020 U.S. FDA approval for the treatment of patients with fourth-line GIST

QINLOCK demonstrated a significant improvement in progression-free survival and a clinically meaningful benefit in overall survival compared to placebo in the pivotal Phase 3 INVICTUS study

QINLOCK approval is the third innovative oncology product approval Zai Lab received in the last 15 months

SHANGHAI, SAN FRANCISCO and WALTHAM, Mass., March 31, 2021 (GLOBE NEWSWIRE) -- Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Deciphera Pharmaceuticals (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced that the China National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.

“We congratulate Zai on gaining this important approval,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “QINLOCK is a new standard of care for patients with fourth-line GIST, and we’re excited to work with our partner Zai as they deliver this innovative medicine to patients in China.”

“The approval of QINLOCK in China is a significant milestone for the GIST community,” said Dr. Shukui Qin, Chief Physician of Cancer Center, Nanjing Jinling Hospital, Senior Vice President of the Chinese Society of Clinical Oncology. “Many GIST patients, who initially responded to traditional tyrosine kinase inhibitors, ultimately developed tumor progression due to secondary mutations. QINLOCK may potentially alter the treatment landscape for patients in China with GIST.”

“Based on the pivotal Phase 3 INVICTUS study, QINLOCK demonstrated compelling clinical benefit in progression-free and overall survival, and was shown to have a favorable safety profile in treating advanced GIST patients,” said Dr. Lin Shen, Vice President of Clinical Oncology at Beijing Cancer Hospital. “We look forward to making this innovative therapy available to patients as soon as possible.”

Deciphera and Zai Lab are also exploring the use of QINLOCK to treat patients with second-line GIST. Deciphera has completed target enrollment in the Phase 3 INTRIGUE study of QINLOCK in patients with second-line GIST, with top-line results anticipated in the second half of 2021.

QINLOCK® (Ripretinib)

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

In March 2021, the NMPA approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In May 2020, the U.S. FDA approved QINLOCK for the treatment of adult patients with advanced GIST who received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan).

About the INVICTUS Phase 3 Study

INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).

Indication

What is QINLOCK?

QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received 3 or more prior treatments for their GIST.

Please see complete Prescribing Information, including Patient Information.

https://www.qinlock.com/

For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab

For more information, visit www.deciphera.com

OUR PIPELINE

https://www.deciphera.com/pipeline/

Zai Lab, Deciphera's Qinlocked OK'd in China for gastrointestinal tumors

Mar. 31, 2021 5:17 AM ET

Zai Lab Limited (ZLAB) By: Mamta Mayani, SA News Editor

The China National Medical Products Administration (NMPA) has approved Zai Lab (NASDAQ:ZLAB) and Deciphera Pharmaceuticals' (NASDAQ:DCPH) New Drug Application (NDA) for Qinlock (ripretinib) for the treatment of adults with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
https://seekingalpha.com/news/3677911-zai-lab-decipheras-qinlocked-okd-in-china-for-gastrointestinal-tumors4
https://seekingalpha.com/symbol/ZLAB
https://seekingalpha.com/symbol/DCPH
https://www.qinlock.com/#isi

Indication What is QINLOCK? QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received 3 or more prior treatments for their GIST. Please see complete Prescribing Information, including Patient Information.

Saxenda® (liraglutide 3.0 mg)

Saxenda® recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years

Bagsværd, Denmark, 26 March 2021 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda® is expanded for the treatment of obesity in adolescents aged 12–17 years.1

If approved, Saxenda® will be the first EU-approved treatment for obesity in adolescents. Saxenda® would be approved for the treatment of adolescents with obesity, with an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults and a body weight above 60 kg, in combination with healthy eating and increased physical activity.1 Saxenda® is already indicated for weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight‑related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.6

About the phase 3 trial (NCT02918279)

The trial investigated the safety and efficacy of Saxenda® (liraglutide 3.0 mg or maximum tolerated dose) compared to placebo for weight management in 251 adolescents (aged 12–17 years) living with obesity as an adjunct to lifestyle therapy. The trial included a 12-week run-in period of lifestyle therapy, a 56-week treatment period (including dose escalation over 4 to 8 weeks) on Saxenda® or placebo and a 26-week follow-up period without Saxenda® or placebo. All participants received lifestyle therapy beginning with the run-in period and during the 56-week treatment period and 26-week follow-up period.7 The evaluation of Saxenda® in the paediatric population was part of the Paediatric Investigation Plan (PIP) for Saxenda®, submitted and agreed upon with the EMA Paediatric Committee (PDCO).8,9

About Saxenda®
Saxenda® (liraglutide 3.0 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,6,10 a hormone that is released in response to food intake.11 Like human GLP-1, Saxenda® is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus.12 Saxenda® for use in adults with obesity was evaluated in the SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) clinical trial programme. Since launch in 2015, more than 1.5 million patients have been treated with Saxenda® globally.13

https://www.saxenda.com/

Novo Nordisk wins EU recommendation for Saxenda label update

Mar. 26, 2021 4:07 PM ET Novo Nordisk A/S (NVO) By: Dulan Lokuwithana, SA News Editor2 Comments

Novo Nordisk (NYSE:NVO) announced that the European Medicines Agency (“EMA”) has recommended the use of Saxenda in the treatment of obesity in adolescents aged 12–17 years.
https://seekingalpha.com/news/3676952-novo-nordisk-wins-eu-recommendation-for-saxenda-label-update
https://seekingalpha.com/symbol/NVO

What is Saxenda®? Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weighta (BMI ≥27) who also have weight-related medical problems or obesityb (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® should be used with a reduced calorie diet and increased physical activity. Click here for the full indication. Be sure to look up your co-pay and ask your health care provider if Saxenda® is right for you. a Body mass index (BMI) ≥27. b BMI ≥30.

Kesimpta® (ofatumumab)

Genmab Announces European Marketing Authorization for Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis

Mar 30, 2021 at 7:22 AM CEST

Company Announcement

Novartis receives European approval for Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in adults
Approval follows positive opinion by European Committee for Medicinal Products for Human Use (CHMP) in January 2021
Approval based on Phase 3 ASCLEPIOS I and II studies
First and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis approved in Europe

Copenhagen, Denmark; March 30, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted Novartis marketing authorization for the use of Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. The EC approval follows a positive opinion issued for subcutaneous ofatumumab in RMS by the CHMP of the European Medicines Agency (EMA) in January 2021. Kesimpta, which is developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG, is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready® autoinjector pen.

Kesimpta® (ofatumumab)

About ASCLEPIOS
The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase 3 studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus teriflunomide 14mg oral tablets taken once daily in adults with a confirmed diagnosis of RMS1,2. The studies enrolled 1,882 patients with RMS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.51,2. The studies were conducted in over 350 sites in 37 countries.

The primary endpoint of both studies was to demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients treated up to 30 months1,2. Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss1,2. Safety and the pharmacokinetic properties of ofatumumab were also all measured throughout the treatment period1,2.

About Kesimpta® (ofatumumab)
Ofatumumab is a fully human CD20 monoclonal antibody. It is self-administered by a once-monthly injection, delivered subcutaneously. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare provider. It is approved in the U.S. for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. In Europe Kesimpta is approved for the treatment of RMS in adults with active disease defined by clinical or imaging features. Kesimpta is the first B-cell therapy that can be self-administered at home by patients using a Sensoready® pen. Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion3. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.

Indication

What is KESIMPTA (ofatumumab) injection?
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.

It is not known if KESIMPTA is safe or effective in children.

Please see full Prescribing Information including Medication Guide.

https://www.kesimpta.com/

For more information, please visit Genmab.com. https://www.genmab.com/

Genmab's Kesimpta OK'd in Europe for multiple sclerosis

Mar. 30, 2021 1:37 AM ET Genmab A/S (GMAB) By: Mamta Mayani, SA News Editor

Genmab (NASDAQ:GMAB) announces that the European Commission (EC) has granted Novartis (NYSE:NVS) marketing authorization for the use of Kesimpta (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults.
https://seekingalpha.com/news/3677432-genmabs-kesimpta-okd-in-europe-for-multiple-sclerosis
https://seekingalpha.com/symbol/GMAB
https://seekingalpha.com/symbol/NVS

Indication What is KESIMPTA (ofatumumab) injection? KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. It is not known if KESIMPTA is safe or effective in children. Please see full Prescribing Information including Medication Guide.

Pemazyre® (pemigatinib)

Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

March 29, 2021 DownloadPDF Format (opens in new window)

- Pemazyre is the first targeted therapy approved in the EU for this indication

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.

“Pemazyre’s approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible.”

The EC decision is based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Interim results from FIGHT-202 demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A [108 patients]), Pemazyre monotherapy resulted in an overall response rate (ORR) of 37 percent (primary endpoint) and a median duration of response (DOR) of 8 months (secondary endpoint) based on an independent central radiographic review. Pemazyre was generally well tolerated. Warnings and precautions for Pemazyre include high and low levels of phosphate in the blood, vision or eye problems, blood creatinine increase and for women who are pregnant, a risk of harm to the fetus.

For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.

Pemazyre® (pemigatinib)

About Pemazyre® (pemigatinib)

Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test8. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

Pemazyre is a trademark of Incyte Corporation.

https://www.pemazyre.com/

For additional information on Incyte, please visit Incyte.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210329005598/en/

Incyte's Pemazyre wins European Commission approval to treat rare form of cancer

Mar. 29, 2021 12:19 PM ET

Incyte Corporation (INCY) By: Aakash Babu, SA News Editor

Incyte (INCY -0.8%) announces that the European Commission (EC) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
https://seekingalpha.com/news/3677260-incytes-pemazyre-wins-european-commission-approval-to-treat-rare-form-of-cancer
https://seekingalpha.com/symbol/INCY
https://www.pemazyre.com/

INDICATIONS AND USAGE PEMAZYRE® is a prescription medicine that is used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery: who have already received a previous treatment, and whose tumor has a certain type of abnormal "FGFR2” gene Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that PEMAZYRE is right for you. It is not known if PEMAZYRE is safe and effective in children. PEMAZYRE is approved based on tumor response and duration of response. There are ongoing studies to show whether PEMAZYRE can improve survival or symptoms.

March 30, 2021

U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine

- If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine[1]
- In the Phase 3 ADVANCE trial for the preventive treatment of migraine in adults with 4-14 migraine days, all active treatment arms of atogepant met their primary endpoint, and the 30 and 60 mg doses met all six secondary endpoints with statistical significance[1]
- Migraine is a debilitating neurological disease affecting 39 million people in the U.S.[2]
- The atogepant application demonstrates AbbVie's longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine

NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.

Migraine is a complex, chronic disease with attacks that are often incapacitating and can include headache pain as well as neurologic and autonomic symptoms.3 Migraine symptoms and severity range widely among individuals.

About the Phase 3 ADVANCE Study
The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, and 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.

The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.69, 3.86, and 4.2 days, respectively, compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001).

A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The trial demonstrated that 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=<.0001).

All doses were well tolerated. The most common adverse events reported with a frequency ≥ 5% in at least one atogepant treatment arm, and greater than placebo, were constipation (6.9-7.7% across all doses vs. 0.5% for placebo), nausea (4.4-6.1% across all doses vs. 1.8% for placebo), and upper respiratory tract infection (3.9-5.7% across all doses vs. 4.5% for placebo). The majority of cases of constipation, nausea and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation.

The study results were announced in a July 2020 press release and presented at the 2020 Virtual Migraine Trust International Symposium.

About the Phase 2b/3 CGP-MD-01 Study
The pivotal Phase 2b/3 clinical trial evaluating the efficacy, safety and tolerability of orally administered atogepant demonstrated that all active treatment arms met the primary endpoint with a statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in those with 4 to 14 migraine days per month. The results were announced in a June 2018 press release and were also presented at the 2019 American Headache Society Annual Meeting.

About the Phase 3 Long-Term Safety Study
The Phase 3, multicenter, randomized, open-label study evaluated the long-term safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks for the preventive treatment of migraine in adults with 4-14 migraine days per month. Further details on the study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting.

About Atogepant
Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

For more information about AbbVie, please visit us at www.abbvie.com.

FDA accepts Abbvie's atogepant application for migraine

Mar. 30, 2021 8:46 AM ETAbbVie Inc. (ABBV)By: Mamta Mayani, SA News Editor6 Comments

The FDA has accepted AbbVie's (NYSE:ABBV) New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine.
https://seekingalpha.com/news/3677551-fda-accepts-abbvies-atogepant-application-for-migraine
https://seekingalpha.com/symbol/ABBV

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Lenzilumab

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Mar 29, 2021 DownloadPDF Format (opens in new window)

Lenzilumab improved the relative likelihood of survival without need for invasive mechanical ventilation (IMV) by 54%, achieving the primary endpoint of the Phase 3 study
Clinical improvement was observed over and above other treatments, including steroids and/or remdesivir

BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. These results are statistically significant.

“The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes in hospitalized hypoxic COVID-19 patients who had not yet progressed to the point of requiring IMV,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “Additionally, the trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population. Our next step is to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) as soon as possible. We are also sharing these results with US governmental agencies and other authorities worldwide.”

About the Lenzilumab Phase 3 Study

This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival. Ventilator-free survival is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.1 The trial enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment. Key secondary endpoints, also measured through 28 days, included ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial are planned to be submitted for potential publication in a peer-reviewed journal.

For more information, visit www.humanigen.com

https://www.humanigen.com/pipeline

Humanigen surges on positive Phase 3 data for COVID-19 therapy

Mar. 29, 2021 7:40 AM ET

Humanigen, Inc. (HGEN) By: Dulan Lokuwithana, SA News Editor9 Comments

Humanigen (NASDAQ:HGEN) has added ~43.8% in the pre-market after announcing that its lead drug candidate against COVID-19, lenzilumab achieved the primary endpoint in a Phase 3 study in patients who were hospitalized with COVID-19 pneumonia.
https://seekingalpha.com/news/3677084-humanigan-surges-on-positive-phase-3-data-for-covid-19-therapy
https://seekingalpha.com/symbol/HGEN

CLINICAL-STAGE PIPELINE

VASCEPA®/VAZKEPA

AMARIN RECEIVES EUROPEAN COMMISSION (EC) APPROVAL FOR VAZKEPA TO REDUCE CARDIOVASCULAR RISK

Back PDF VersionMar 30, 2021

Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT® 1, 2

DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that following a review and approval recommendation by the European Medicines Agency (EMA), the European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.

Amarin’s icosapent ethyl was approved for cardiovascular risk reduction by the U.S. Food and Drug Administration (FDA) in December 2019 and is marketed in the U.S. under the brand name, VASCEPA®.

“The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides,” said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin. “We look forward to launching VAZKEPA in Europe as it is an exciting opportunity for Amarin to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event.”

The EC approval for VAZKEPA is based on over a decade of development and testing of icosapent ethyl, including efficacy and safety data from the REDUCE-IT® cardiovascular outcomes study.2 REDUCE-IT evaluated more than 8,000 high risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p<0.001) in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl (4 grams daily) compared with placebo.

VASCEPA®/VAZKEPA

About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.5 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.6 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.

Indications and Limitation of Use (in the United States)
VASCEPA is indicated:

As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.

Amarin wins EU approval for icosapent ethyl to treat cardiovascular patients

Mar. 30, 2021 7:42 AM ET

Amarin Corporation plc (AMRN)

By: Dulan Lokuwithana, SA News Editor5 Comments

Amarin Corporation (NASDAQ:AMRN) has added ~4.9% in the pre-market after announcing that the European Commission has approved its marketing application for Vazkepa (icosapent ethyl) to treat high-risk cardiovascular patients.
https://seekingalpha.com/news/3677505-amarin-wins-eu-nod-for-icosapent-ethyl-to-treat-cardiovascular-patients
https://seekingalpha.com/symbol/AMRN
https://www.vascepa.com/
https://amarincorp.com/default.aspx

WHAT IS VASCEPA? VASCEPA is a prescription medicine used: along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease. along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if VASCEPA is safe and effective in children.

Leronlimab (PRO 140)

CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients

Download as PDF

March 30, 2021 6:00am EDT

Clinical outcome improvement (based on ordinal scale) with leronlimab at day 14 was 400% better than placebo arm with p-value of 0.021

VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19.

Upon further statistical analysis of the critically ill population (hospitalized patients receiving invasive mechanical ventilation (IMV) or ECMO), it was revealed that when leronlimab was added to standard of care (“SoC”), leronlimab decreased mortality at 14 days by 82% (p=.0233, N=62). Patients who received leronlimab were over five times more likely to be alive at day 14 than those who received SoC only.

Furthermore, leronlimab administration was associated with a 400% improvement in the ranking on the 7-point ordinal scale at 14 days when given in conjunction with SoC (p=.021, N=62) in the critically ill population, which provides direct evidence of tangible patient improvement.

This analysis builds upon the previously released information from the Company’s mITT analysis of CD12 showing:

A clear benefit when leronlimab was used in addition to “commonly used COVID-19 treatments,” in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 28.1% (N=309, p=.0319).
A clear benefit when leronlimab was used in combination with dexamethasone, in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.0% (N=233, p=.0552).
Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).
A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73% when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age ≤ 65 years old.
A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 16.3% and a relative risk reduction of death of 73.5% when leronlimab was used in addition to dexamethasone in the critically ill population ≤ 65 years old.

Leronlimab (PRO 140)

About Leronlimab (PRO 140)
The FDA has granted a FastTrack designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

Research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control in the setting of cancer. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation by the FDA in May 2019.

More information is at www.cytodyn.com.

CytoDyn’s leronlimab reduces mortality by 82% at 14 days in critically ill COVID-19 patients

Mar. 30, 2021 7:08 AM ETCytoDyn Inc. (CYDY)By: Mamta Mayani, SA News Editor8 Comments

CytoDyn (OTCQB:CYDY) announces further results from its CD12 trial of severe-to-critically ill COVID-19 patients.
https://seekingalpha.com/news/3677479-cytodyns-cydy-leronlimab-reduces-mortality-by-82-in-critical-covid-19-patients
https://seekingalpha.com/symbol/CYDY

Drug Database: Leronlimab

https://clinicalinfo.hiv.gov/en/drugs/leronlimab/patient

CytoDyn Files New Protocol with U.S. FDA for 4 Doses of Leronlimab for Critically Ill COVID-19 Patients with the Objective to Duplicate or Surpass 82% Survival Benefit with P-Value of 0.0233 Originally Achieved from Two Weeks of Treatment in CD12 Trial With 2 Doses

Apr 01, 2021 6:00am EDT

CytoDyn files new protocol with FDA for 4 doses of leronlimab for critical COVID-19

Apr. 01, 2021 6:13 AM ETCytoDyn Inc. (CYDY)By: Mamta Mayani, SA News Editor23 Comments

After several weeks of discussions with the FDA and analysis of CD12 trial data, CytoDyn (OTCQB:CYDY) has filed a new protocol for leronlimab to extend treatment to four weeks.
https://seekingalpha.com/news/3678429-cytodyn-files-new-protocol-with-fda-for-4-doses-of-leronlimab-for-critical-covid-19
https://seekingalpha.com/symbol/CYDY

Building a Broad Pipeline of Indications

Bamlanivimab with VIR-7831

Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19

03/29/21 at 8:30 AM EDTPDF Version– In combination, the two monoclonal antibodies demonstrated a 70% relative reduction in persistently high viral load at day 7 compared to placebo –

INDIANAPOLIS and SAN FRANCISCO and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE: LLY), Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.

In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There were no events for the secondary endpoint of COVID-19 related hospitalization or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.

Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.

Bamlanivimab with VIR-7831

Important Information about bamlanivimab
Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

Authorized Use and Important Safety Information
Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

About BLAZE-4
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include viral load change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

About COMET-ICE
COMET-ICE is a multi-center, double-blind, placebo-controlled Phase 3 trial evaluating VIR-7831 in adults with mild or moderate COVID-19 at high risk of progression to severe disease. The trial was stopped for enrollment on March 10, 2021, based on an interim analysis, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo.

About bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

About VIR-7831 / GSK4182136
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Vir and GSK Coronavirus Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Lilly’s COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly’s COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.

For more information, please visit www.vir.bio.

For further information please visit www.gsk.com/about-us.

Lilly, Vir Bio, GSK's cocktail antibody shows positive action in COVID-19

Mar. 29, 2021 8:50 AM ETEli Lilly and Company (LLY)By: Mamta Mayani, SA News Editor4 Comments

Eli Lilly (NYSE:LLY), Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline (NYSE:GSK) announce topline data from the expanded phase 2 BLAZE-4 trial studying low-risk adult patients with mild-to-moderate COVID-19.
https://seekingalpha.com/news/3677146-lilly-vir-bio-gsks-cocktail-antibody-shows-positive-action-in-covid-19
https://seekingalpha.com/symbol/LLY
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/VIR

We are developing a broad portfolio of product candidates that are designed to combat serious, global infectious diseases in entirely new ways, creating medicines that will have a meaningful impact on people around the world. Given the global impact of infectious diseases, we are committed to developing cost-effective treatments that can be delivered at scale.

biotecMAX™ January/ February/March 2021 Insight

XTANDI™ (enzalutamide)

Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate CancerIf approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer

TOKYO, March 26, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).1 Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.2

If approved by the European Commission (EC), enzalutamide will be the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC.3 The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.4

Data from the ARCHES trial showed that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).4

XTANDI™ (enzalutamide)

About XTANDI™ (enzalutamide)
Enzalutamide is currently indicated in the EU for:3

the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC);
the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; and
the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

https://www.xtandi.com/

For more information, please visit our website at https://www.astellas.com/en.

About the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc, which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.

Astellas Press Release. XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis. Available at: https://www.astellas.com/system/files/news/2020-05/20200529_en_1.pdf. Last accessed March 2021.

Astellas and Pfizer's XTANDI gets EMA positive opinion for additional indication

Mar. 26, 2021 8:53 AM ET Pfizer Inc. (PFE) By: Aakash Babu, SA News Editor

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on an additional indication for Astellas Pharma (OTCPK:ALPMY) and Pfizer's (NYSE:PFE) XTANDI treatment for adult men with metastatic hormone-sensitive prostate cancer.
https://seekingalpha.com/news/3676755-astellas-and-pfizers-xtandi-gets-ema-positive-opinion-for-additional-indication
https://seekingalpha.com/symbol/ALPMY
https://seekingalpha.com/symbol/PFE

https://www.xtandi.com/

What is XTANDI? XTANDI is a prescription medicine used to treat men with prostate cancer that: no longer responds to a hormone therapy or surgical treatment to lower testosterone OR has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone It is not known if XTANDI is safe and effective in females or children.

ABECMA (idecabtagene vicleucel)

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

03/26/2021CATEGORY:

Corporate/Financial News

Abecma is a first-in-class BCMA-directed personalized immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma1

In the pivotal KarMMa trial, the majority (72%) of patients achieved rapid, deep and durable responses1

Safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that are mostly low-grade with early onset and resolution1

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.1 As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.2 Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities (NT), Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), and Prolonged Cytopenia.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210326005507/en/

(Photo: Business Wire)

“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Bristol Myers Squibb is now the only company with two approved CAR T cell therapies with distinct targets of CD19 and BCMA. As our second FDA-approved CAR T cell therapy, Abecma underscores our commitment to deliver on the promise of cell therapies for patients who are battling aggressive and advanced blood cancers with limited effective treatment options.”

ABECMA (idecabtagene vicleucel)

Indication

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.

For more information about Bristol Myers Squibb, visit us at BMS.com

For more information, visit bluebirdbio.com.

Bristol Myers and Bluebird bio win FDA approval for ide-cel in multiple myeloma

Mar. 26, 2021 11:40 PM ET Bristol-Myers Squibb Company (BMY)

By: Dulan Lokuwithana, SA News Editor21 Comments

Bristol Myers Squibb (NYSE:BMY) and bluebird bio (NASDAQ:BLUE) announced the FDA approval for idecabtagene vicleucel (ide-cel) for a certain category of adult patients with relapsed or refractory multiple myeloma. The FDA authorization has come a day ahead of the action date.
https://seekingalpha.com/news/3677011-bristol-myers-and-bluebird-bio-wins-fda-approval-for-ide-cel-in-multiple-myeloma
https://seekingalpha.com/symbol/BLUE
https://seekingalpha.com/symbol/BMY

pipeline

VIR-7831

GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19

03/26/21 at 8:30 AM EDTPDF Version

LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

VIR-7831

About the VIR-7831 Clinical Development Program
In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority.

About VIR-7832 / GSK4182137
VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

For further information please visit www.gsk.com/about-us.

For more information, please visit www.vir.bio.

https://www.vir.bio/pipeline/

GlaxoSmithKline and Vir Biotech seek FDA authorization for COVID-19 therapy

Mar. 26, 2021 8:47 AM ET GlaxoSmithKline plc (GSK) By: Dulan Lokuwithana, SA News Editor2 Comments

GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology (NASDAQ:VIR) announced the submission of an application to the FDA requesting the Emergency Use Authorization (“EUA”) for VIR-7831, a SARS-CoV-2 monoclonal antibody.
https://seekingalpha.com/news/3676752-glaxosmithkline-and-vir-biotech-seek-fda-approval-for-covid-19-therapy
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/VIR

IBRANCE® (PALBOCICLIB)

REAL-WORLD EVIDENCE SUPPORTS EFFECTIVENESS OF FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

Thursday, March 25, 2021 - 06:45am

First large-scale comparative effectiveness analysis of a CDK 4/6 inhibitor plus letrozole evaluating progression-free and overall survival versus letrozole alone

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced the peer-reviewed publication of real-world evidence (RWE) demonstrating that first-line therapy with IBRANCE® (palbociclib) in combination with letrozole was associated with improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (mBC) compared with letrozole alone. These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research.

At a median follow-up of approximately two years and after balancing for baseline demographic and clinical characteristics, median rwPFS was 20.0 months with IBRANCE plus letrozole versus 11.9 months with letrozole alone (HR 0.58: 95% CI, 0.49 to 0.69; p<0.0001) in this observational, retrospective real-world analysis. Median OS was not reached among patients in the IBRANCE group and was 43.1 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53 to 0.82; P=0.0002). These findings represent a 42% reduction in the risk of progression and a 34% reduction in the risk of death.

IBRANCE® (PALBOCICLIB)

Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”

The analysis also showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole. The rwPFS and OS benefits were generally consistent across all subgroups, including younger patients (18-50 years of age) and site or extent of metastases.

“Real-world evidence is increasingly used to complement traditional randomized clinical trial data to better understand a therapy’s effectiveness in routine clinical practice and inform treatment decisions,” said Angela DeMichele, M.D., lead researcher and Professor in Breast Cancer Excellence in the Perelman School of Medicine at the University of Pennsylvania. “The findings from this landmark real-world study align with the positive impact that I have seen in my own patients treated with IBRANCE combination therapy.”

The data for this retrospective observational analysis was collected from the Flatiron Health de-identified longitudinal database, which includes patient records from Flatiron’s network of more than 280 community cancer clinics and partnerships with major academic cancer centers across the U.S. This real-world cohort includes more than 1,400 women with HR+, HER2- mBC with any extent of visceral disease. Safety data were not collected as part of this analysis.

The data from this real-world analysis is consistent with available data from the Phase 3 PALOMA-2 trial, which studied IBRANCE plus letrozole versus placebo plus letrozole as initial endocrine-based therapy in post-menopausal women with estrogen-receptor positive (ER+), HER2- mBC. However, this observational analysis differs from the randomized clinical trial in several ways. The studies have different endpoints and there are inherent limitations in real-world observational studies, including lack of randomization, lack of uniform timing or type of clinical assessments and challenges with missing data. OS data is being collected in the PALOMA-2 randomized clinical trial but is not yet mature.

About IBRANCE® (palbociclib) 125 mg tablets and capsules

IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.

IMPORTANT IBRANCE®(palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

to learn more, please visit us on www.Pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005221/en/

https://seekingalpha.com/symbol/PFE

INDICATIONS

IBRANCE 125 mg capsules and tablets are a prescription medicine used in adults to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic) in combination with:

an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or
fulvestrant in people with disease progression following hormonal therapy.

Please see Full Prescribing Information and Patient Information.

https://www.ibrance.com/

INDICATIONS IBRANCE 125 mg capsules and tablets are a prescription medicine used in adults to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic) in combination with: an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or fulvestrant in people with disease progression following hormonal therapy. Please see Full Prescribing Information and Patient Information.

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor

Vertex Receives CHMP Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat People With Cystic Fibrosis With At Least One F508del Mutation

- If approved, people ages 12 years and older who have one copy of the F508del mutation and a gating (F/G) or residual function (F/RF) mutation will now be eligible for triple combination therapy -

LONDON – [26 March 2021] – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide. If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine.

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor

In Europe, KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is currently licensed for the treatment of people with CF ages 12 years and older with an F/F or F/MF genotype.

About KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a Combination With Ivacaftor

KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor 150 mg was developed for the treatment of cystic fibrosis (CF) in patients ages 12 years and older with two F508del mutations (F/F) or one F508del mutation and one minimal function mutation (F/MF) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor/tezacaftor/elexacaftor is designed to increase the quantity and function of the F508del-CFTR protein at the cell surface. The current approved EU licensed indication for ivacaftor/tezacaftor/elexacaftor was supported by positive results of two global Phase 3 studies in people ages 12 years and older with CF: a 24-week Phase 3 study in 403 people with one F508del mutation and one minimal function mutation (F/MF) and a four-week Phase 3 study in 107 people with two F508del mutations (F/F).

the company's website at www.vrtx.com

Vertex's KAFTRIO combo gets EMA positive opinion for label extension

Mar. 26, 2021 7:43 AM ET Vertex Pharmaceuticals Incorporated (VRTX) By: Aakash Babu, SA News Editor

Vertex Pharmaceuticals (NASDAQ:VRTX) has received positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the label extension of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis.
https://seekingalpha.com/news/3676712-vertexs-kaftrio-combo-gets-ema-positive-opinion-for-label-extension
https://seekingalpha.com/symbol/VRTX
https://www.vrtx.com/research-development/pipeline/

What is the Vertex Strategy?

PONVORY™ (ponesimod)

Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging FeaturesPositive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis[1]
The OPTIMUM study demonstrated a statistically significant reduction in relapses and number of inflammatory lesions compared with teriflunomide[2]

BEERSE, BELGIUM, MARCH 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for PONVORY™ (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[3]

“Relapsing forms of multiple sclerosis (MS) have varied and often unpredictable symptoms, posing a unique human, societal and economic burden,” said Catherine Taylor, M.D., Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Johnson & Johnson Middle East FZ-LLC. “Despite continuous innovations in the treatment landscape, unmet needs remain. If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.”

PONVORY™ (ponesimod)

About Ponesimod
Ponesimod is a highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.[7] In patients with MS, inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.[8]

A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd, is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Adverse events should be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com and to regulatory authorities.

Learn more at www.janssen.com/emea.

J&J's multiple sclerosis drug Ponvory receives positive CHMP opinion

Mar. 26, 2021 8:48 AM ET Johnson & Johnson (JNJ) By: Jonathan M Block, SA News Editor

The European Medicine Agency's Committee for Medicinal Products for Human Use ("CHMP") has adopted a positive opinion for Johnson & Johnson's (NYSE:JNJ) Ponvory (ponesimod) as an oral treatment for relapsing multiple sclerosis.
The FDA approved Ponvory earlier this month.
https://seekingalpha.com/news/3676745-johnson-johnson-multiple-sclerosis-drug-ponvory-receives-positive-chmp-opinion
https://seekingalpha.com/symbol/JNJ
https://www.jnj.com/

The European Medicines Agency’s CHMP issues a positive opinion recommending marketing authorisation for Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis

March 26, 2021 08:28 ET | Source: Idorsia Pharmaceuticals Ltd

Allschwil, Switzerland – March 26, 2021

https://www.globenewswire.com/news-release/2021/03/26/2200054/0/de/The-European-Medicines-Agency-s-CHMP-issues-a-positive-opinion-recommending-marketing-authorisation-for-Ponvory-ponesimod-to-treat-adults-with-relapsing-forms-of-multiple-sclerosis.html

Indication PONVORY™ is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

TRODELVY™ (sacituzumab govitecan-hziy)

March 25, 2021

European Medicines Agency Validates Marketing Authorization Application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer

– Agency Grants Accelerated Assessment Based on Positive Results of Phase 3 ASCENT Trial –

– Supplementary Biologics License Application Currently Under Review by the U.S. FDA for Full Marketing Approval –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease. The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation.

SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Currently, in the European Union (EU), there is no authorized standard treatment regimen with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC.

SG (under the tradename Trodelvy®) received accelerated approval by the U.S. Food and Drug Administration (FDA) to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

About the ASCENT Study

The Phase 3 ASCENT study, an international, multi-center, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic TNBC who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either sacituzumab govitecan-hziy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint of the study was progression-free survival (PFS) in patients without brain metastasis at baseline. Secondary endpoints include PFS for the full study population, OS, objective response rate (ORR), duration of response (DoR), and time to response. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

About Sacituzumab Govitecan-Hziy

SG is an antibody and topoisomerase inhibitor conjugate directed to the Trop-2 cell surface antigen, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse.

In addition to multiple ongoing studies of SG in triple-negative breast cancer, it is being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/HER 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005912/en/

EMA validates Gilead's breast cancer treatment marketing authorization application

Mar. 25, 2021 4:19 PM ET Gilead Sciences, Inc. (GILD) By: Aakash Babu, SA News Editor

Gilead Sciences (NASDAQ:GILD) announces that the European Medicines Agency (EMA) has backed the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of certain adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
https://seekingalpha.com/news/3676567-ema-validates-gileads-breast-cancer-treatment-marketing-authorization-application
https://seekingalpha.com/symbol/GILD

WHAT IS TRODELVY?

TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease.

TRODELVY is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

https://trodelvy.com/

PADCEV (enfortumab vedotin-ejfv)

European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin

03/26/2021

- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -

TOKYO & BOTHELL, Wash.--(BUSINESS WIRE)--

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). The MAA requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the European Union for people living with urothelial cancer.

Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.

About the EV-301 Trial

The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.6

About Enfortumab Vedotin

Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7,8 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).8

PADCEV (enfortumab vedotin-ejfv) U.S. Important Safety Information

PADCEV (enfortumab vedotin-ejfv)

WHAT IS PADCEV™?

PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine. It is not known if PADCEV is safe and effective in children.

PADCEV was FDA-approved based on a clinical study that measured how many patients had a tumor response. There is another study with PADCEV to confirm the clinical benefit.

https://www.padcev.com/

For more information, please see the full Prescribing Information for PADCEV here.

About the Astellas and Seagen Collaboration

Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV® (enfortumab vedotin-ejfv). In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005903/en/

EMA accepts Astellas, Seagen's enfortumab vedotin application in urothelial cancer

Mar. 26, 2021 3:04 AM ET Astellas Pharma Inc. (ALPMF) By: Mamta Mayani, SA News Editor

The EMA has accepted Astellas Pharma (OTCPK:ALPMF) and Seagen's (NASDAQ:SGEN) marketing authorization application (MAA) for enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant setting.
https://seekingalpha.com/news/3676653-ema-accepts-enfortumab-vedotin-application-in-urothelial-cancer
https://seekingalpha.com/symbol/ALPMF
https://seekingalpha.com/symbol/SGEN

R&D Pipeline The list shows the development status in the target diseases for which we aim to obtain approval in Japan, the United States, Europe and/or China. As of Jan 2021

https://sw4503.swcms.net/en/ir-library/pipeline/inframe/main/01/teaserItems1/0/linkList/0/link/3q2020_pip_en.pdf

Major Pipeline

https://www.astellas.com/en/science/pipeline

WHAT IS PADCEV™? PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine. It is not known if PADCEV is safe and effective in children. PADCEV was FDA-approved based on a clinical study that measured how many patients had a tumor response. There is another study with PADCEV to confirm the clinical benefit.

CINREBAFUSP ALFA (PRS-343) IN COMBINATION WITH TUKYSA® (TUCATINIB)

PIERIS ANNOUNCES AMENDMENT OF EXISTING IMMUNO-ONCOLOGY MULTI-TARGET COLLABORATION WITH SEAGEN, A CLINICAL TRIAL AND SUPPLY AGREEMENT TO EVALUATE CINREBAFUSP ALFA (PRS-343) IN COMBINATION WITH TUKYSA® (TUCATINIB) IN GASTRIC CANCER, AND STRATEGIC EQUITY INVESTMENT BY SEAGEN

Download PDF

Seagen will supply Pieris with TUKYSA® to evaluate the drug in combination with cinrebafusp alfa (PRS-343) in gastric cancer
Pieris' co-development option for one program from existing multi-target collaboration amended to US co-promotion option with increased royalties if exercised
Seagen to purchase $13 million equity stake in Pieris common stock

BOSTON, MA / ACCESSWIRE / March 25, 2021 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that Seagen has made a strategic equity investment in Pieris as part of an ongoing collaboration between the companies. In addition, the companies have entered into a clinical trial collaboration agreement to evaluate the safety and efficacy of combining Pieris' cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, with Seagen's TUKYSA® (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration agreement around joint development and commercial rights for the second of up to three products in the alliance.

The combination of cinrebafusp alfa and TUKYSA could potentially address a high medical need in HER2 low-expressing gastric cancer patients who do not respond to traditional HER2-targeted therapies. Preclinical studies show that TUKYSA synergizes with cinrebafusp alfa to enhance its 4-1BB-mediated immune cell stimulation. This effect was observed across a range of HER2 expressing cell lines (IHC3+, 2+, and 1+), including those where cinrebafusp alfa had limited single-agent activity.

"Preclinical data exploring the combination of cinrebafusp alfa and TUKYSA are encouraging and support evaluating the combination in the planned phase 2 clinical trial," said Marjorie Green, M.D., Senior Vice President, Late-Stage Development of Seagen. "We are pleased to supply drug for Pieris to explore the potential combination of these agents to address an important unmet medical need."

About Cinrebafusp Alfa
Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. The drug candidate is currently in development for the treatment of HER2-positive solid tumors. Based on encouraging phase 1 study results, which demonstrated clinical benefit as single agent and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel for the treatment of HER2-positive gastric cancer and, under the phase 2 protocol, in combination with tucatinib.

About Pieris Pharmaceuticals:
Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies, including AstraZeneca, Seagen, and Servier. Anticalin® is a registered trademark of Pieris. For more information, visit www.pieris.com.

ANTICALIN PROTEINS IN IMMUNO-ONCOLOGY

https://www.pieris.com/pipeline/immuno-oncology/anticalin-proteins-in-immuno-oncology

Seagen invests $13M in Pieris, inks deal for PRS-343 + Tuksya in gastric cancer

Mar. 25, 2021 8:33 AM ET Pieris Pharmaceuticals, Inc. (PIRS) By: Mamta Mayani, SA News Editor

Pieris Pharmaceuticals (NASDAQ:PIRS) soars 15% premarket after Seagen (NASDAQ:SGEN) makes a strategic equity investment in the company as part of an ongoing collaboration between them.
https://seekingalpha.com/news/3676224-seagen-invests-13m-in-pieris-inks-deal-for-prs-343-tuksya-in-gastric-cancer
https://seekingalpha.com/symbol/PIRS
https://seekingalpha.com/symbol/SGEN

TUKYSA® (TUCATINIB)

Indication

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

https://www.seagen.com/medicines/tukysa

https://www.tukysa.com/

What is TUKYSA? TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments. It is not known if TUKYSA is safe and effective in children. Please see Important Facts about TUKYSA.

Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab)

Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma, Meets Primary Endpoint of Progression-Free Survival

MAR 25, 2021

First Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody

Relatlimab is the company’s third distinct checkpoint inhibitor to demonstrate a benefit for patients

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing. The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the third distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for Bristol Myers Squibb and, with Opdivo, the first fixed-dose combination to demonstrate a benefit for patients.

Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab)

About RELATIVITY-047 (CA224-047)

RELATIVITY-047 (CA224-047) is a randomized, double-blind Phase 2/3 study evaluating the fixed-dose combination of relatlimab and Opdivo in patients with previously untreated metastatic or unresectable melanoma versus Opdivo alone. The primary endpoint of the trial is progression-free survival (PFS) by Blinded Independent Central Review (BICR) and the secondary endpoints are overall survival (OS) and objective response rate (ORR). A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of relatlimab 160 mg and Opdivo 480 mg or Opdivo 480 mg by intravenous infusion every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow up for the secondary endpoints of OS and ORR is ongoing.

About Opdivo ®

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

https://www.opdivo.com/

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Please see US Full Prescribing Information for OPDIVO and YERVOY.

For more information about Bristol Myers Squibb, visit us at BMS.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005311/en/

Bristol Myers’ anti-LAG-3 antibody achieves primary endpoint in melanoma trial

Mar. 25, 2021 7:18 AM ET

Bristol-Myers Squibb Company (BMY)

By: Dulan Lokuwithana, SA News Editor

Bristol Myers Squibb (NYSE:BMY) announces that its Phase 2/3 RELATIVITY-047 trial for combination therapy of relatlimab, and Opdivo (nivolumab) has achieved the primary endpoint in patients with previously untreated metastatic or unresectable melanoma.
https://seekingalpha.com/news/3676126-bristol-myers-anti-lag-3-antibody-achieves-primary-endpoint-melanoma-trial
https://seekingalpha.com/symbol/BMY

ORGOVYX™ (relugolix)

MYOVANT SCIENCES AND PFIZER ANNOUNCE POSITIVE DATA FROM PHASE 3 LIBERTY RANDOMIZED WITHDRAWAL STUDY OF ONCE-DAILY RELUGOLIX COMBINATION THERAPY IN WOMEN WITH UTERINE FIBROIDS

Wednesday, March 24, 2021 - 06:30amEST

78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001)
69.8% of women who continued relugolix combination therapy remained responders through Week 104
88.3% of women who discontinued treatment relapsed with heavy menstrual bleeding, on average 5.9 weeks after discontinuation
Myovant to host conference call and webcast today at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

BASEL, Switzerland and NEW YORK, March 24, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced positive data from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

“Since many women with uterine fibroids spend years struggling to manage their symptoms, there is a critical need for non-invasive long-term treatment options,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago and LIBERTY Program Steering Committee Member. “Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.”

ORGOVYX™ (relugolix)

The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001). All three key secondary endpoints in the LIBERTY randomized withdrawal study were also achieved, including sustained responder rate at two years (Week 104), time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001). Through two years, 69.8% of women who continued on relugolix combination therapy remained responders. 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.

Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.

Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021 target action date.

About the Phase 3 LIBERTY Program in Uterine Fibroids

The Phase 3 clinical program for uterine fibroids consisted of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women could elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy and to evaluate the need for maintenance therapy. Across studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

LIBERTY 1 and 2 met their primary endpoints (p < 0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving relugolix combination therapy in both studies experienced an 84.3% reduction in menstrual blood loss from baseline at Week 24 (p < 0.0001). Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies.

The open-label extension study also met its primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at Week 52. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.

For more information, please visit our website at www.myovant.com

to learn more, please visit us on www.Pfizer.com

Pfizer, Myovant Sciences' relugolix combo shows positive action in uterine fibroids

Mar. 24, 2021 6:54 AM ET Pfizer Inc. (PFE) By: Mamta Mayani, SA News Editor

Myovant Sciences (NYSE:MYOV) and Pfizer (NYSE:PFE) announce positive data from Phase 3 LIBERTY withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.
https://seekingalpha.com/news/3675564-pfizer-myovant-sciences-relugolix-combo-shows-positive-action-in-uterine-fibroids
https://seekingalpha.com/symbol/PFE
https://seekingalpha.com/symbol/MYOV

What is ORGOVYX?

ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer.

It is not known if ORGOVYX is safe or effective in females or children.

Please see full Prescribing Information and Patient Product Information for ORGOVYX.

https://www.orgovyx.com/

GAVRETO® (pralsetinib)

CStone Announces New Drug Approval of GAVRETO® (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients

Times：2021.03.24 Author：CStone

- GAVRETO has been approved for the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer after platinum-based chemotherapy
- GAVRETO is the first approved selective RET inhibitor in China and first approved precision therapy for CStone

SUZHOU, China, March 24, 2021 - - CStone Pharmaceuticals (CStone, HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration (NMPA) of China has approved GAVRETO® (pralsetinib) capsules for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. Discovered by CStone’s partner Blueprint Medicines, GAVRETO is China’s first approved selective RET inhibitor, as well as CStone’s first approved precision therapy in China.

Dr. Frank Jiang, Chairman and CEO of CStone, noted: “This is a key milestone for CStone. The approval of GAVRETO in China reflects CStone’s commitment to research and develop innovative therapies to meet patients’ unmet medical needs as well as strong execution capabilities. We would like to thank all the patients and investigators involved in the clinical study and extend our gratitude to the NMPA and other government authorities for their support in the priority review leading to the fast approval of GAVRETO. We continue to advance the development of GAVRETO in other indications such as first-line NSCLC, thyroid cancer and other solid tumors, aiming to bring the treatment to more patients soon.”

GAVRETO® (pralsetinib)

About GAVRETO (pralsetinib)

GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the NMPA of China for the treatment of adults with locally advanced or metastatic rearranged during transfection (RET) fusion-positive NSCLC after platinum-based chemotherapy.

GAVRETO has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

GAVRETO is not approved for the treatment of any other indication in China by the NMPA or in the U.S. by the FDA, or for any indication in any other jurisdiction by any other health authority.

GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. In preclinical studies, GAVRETO inhibited RET at lower concentrations than other pharmacologically relevant kinases, including VEGFR2, FGFR2, and JAK2.

Blueprint Medicines and Roche are co-developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-altered NSCLC, thyroid cancer, and other solid tumors. Blueprint Medicines and Genentech, a member of the Roche Group, are co-commercializing GAVRETO in the U.S., and Roche has exclusive commercialization rights for GAVRETO outside of the U.S. (excluding greater China). The European Medicines Agency validated a marketing authorization application for GAVRETO for the treatment of RET fusion-positive NSCLC, and the review is ongoing. The FDA granted breakthrough therapy designation to GAVRETO for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

https://www.gavreto.com/

Blueprint Medicines partner CStone wins Chinese approval for lung cancer therapy

Mar. 24, 2021 11:04 AM ET CStone Pharmaceuticals (CSPHF) By: Dulan Lokuwithana, SA News Editor

CStone Pharmaceuticals (OTCPK:CSPHF) announced that the National Medical Products Administration (“NMPA”) of China has approved Gavreto (pralsetinib) for the treatment of a certain group of adult patients with non-small cell lung cancer (“NSCLC”).
https://seekingalpha.com/news/3675725-blueprint-medicines-partner-cstone-wins-chinese-approval-for-lung-cancer-therapy
https://seekingalpha.com/symbol/CSPHF
https://www.blueprintmedicines.com/
https://seekingalpha.com/symbol/BPMC
https://www.blueprintmedicines.com/pipeline/clinical-programs/
https://www.gavreto.com/

WHAT IS GAVRETO™ (pralsetinib)? GAVRETO is a prescription medicine used to treat certain cancers caused by abnormal rearranged during transfection (RET) gene in: adults with non-small cell lung cancer (NSCLC) that has spread adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy) adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working Your healthcare provider will perform a test to make sure that GAVRETO is right for you. GAVRETO was approved based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of GAVRETO.

biotecMAX™ January/ February/March 2021 Insight

REGEN-COV (casirivimab with imdevimab)

March 23, 2021 at 2:00 AM EDT Back

PHASE 3 TRIAL SHOWS REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) ANTIBODY COCKTAIL REDUCED HOSPITALIZATION OR DEATH BY 70% IN NON-HOSPITALIZED COVID-19 PATIENTS

TARRYTOWN, N.Y., March 23, 2021 /PRNewswire/ --

REGEN-COV also significantly shortened the duration of symptoms by 4 days

All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar efficacy across all endpoints

Companion dose-ranging Phase 2 trial showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg

FDA recently updated U.S. EUA fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV is the only one to retain potency against key emerging variants

Regeneron will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to EUA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567). This definitive Phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients ("outpatients") met its primary endpoint, showing the investigational REGEN-COV™ (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo.

This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting," said Suraj Saggar, D.O., trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. "With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death."

REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration. In addition, a companion Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses.

"With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients. These Phase 3 data will also form the basis of a full Biologics License Application."

REGEN-COV (casirivimab with imdevimab)

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Under an EUA issued by the FDA, REGEN-COV is currently available in the U.S. to treat mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

REGEN-COV is currently authorized and available in a 2,400 mg IV dose, with infusion times as short as 20 minutes. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

Regeneron is collaborating with Roche to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COVTM (casirivimab with imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn

Authorized Emergency Use
REGEN-COV, (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]

REGEN-COV has not been approved, but has been authorized for emergency use by FDA
This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/phase-3-trial-shows-regen-cov-casirivimab-with-imdevimab-antibody-cocktail-reduced-hospitalization-or-death-by-70-in-non-hospitalized-covid-19-patients-301253401.html

SOURCE Regeneron Pharmaceuticals, Inc.

Regeneron's COVID-19 antibody reduces hospitalization, death by 70%

Mar. 23, 2021 2:47 AM ET Regeneron Pharmaceuticals, Inc. (REGN) By: Mamta Mayani, SA News Editor2 Comments

Regeneron Pharmaceuticals (NASDAQ:REGN) announces positive topline results from Phase 3 outcomes trial assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567).

https://seekingalpha.com/news/3675066-regenerons-covid-19-antibody-reduces-hospitalization-death-by-70

https://seekingalpha.com/symbol/REGN

Regeneron Covid-19 Antibody Drug Reduced Risk of Hospitalization, Death by 70% in Late-Stage Trial The drug was effective at a higher dose already in use and a lower dose, which the company said it would seek permission to start selling By Joseph Walker March 23, 2021 2:00 am ET

#BBCNews

US trial of Oxford-AstraZeneca vaccine confirms safety and effectiveness - BBC News

•Mar 22, 2021 BBC News
Results from the long-awaited US trial of the Oxford-AstraZeneca Covid vaccine have confirmed that the shot is both safe and highly effective. The vaccine was 79% effective at stopping symptomatic Covid and 100% effective at preventing people from falling seriously ill. There were also no safety issues regarding blood clots. More than 32,000 volunteers took part in the study, mostly in America, but also in Chile and Peru.

U.S. study finds AstraZeneca vaccine 79% effective against symptomatic COVID-19

Mar 22, 2021 CBS News
Drugmaker AstraZeneca is preparing to request emergency use authorization for its coronavirus vaccine in the U.S. after its latest clinical trial finds the vaccine was fully effective in preventing COVID-19 hospitalizations and 79% effective in stopping symptomatic illness. Dr. Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, joins CBSN to discuss the potential impact in the fight against the pandemic.

AZD1222

AZD1222 US Phase III primary analysis confirms safety and efficacy

PUBLISHED25 March 2021

25 March 2021 00:45 GMT

76% vaccine efficacy against symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

85% efficacy against symptomatic COVID-19 in participants aged 65 years and over

Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.

These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks.

This primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from the 32,449 trial participants, an additional 49 cases to the previously announced interim analysis. Participants were randomised on a 2:1 ratio between the vaccine and placebo group.

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd1222-us-phase-iii-primary-analysis-confirms-safety-and-efficacy.html

Updated analysis finds AstraZeneca vaccine 76% effective against COVID-19

Mar. 24, 2021 10:52 PM ET AstraZeneca PLC (AZN) By: Jonathan M Block, SA News Editor1 Comment

AstraZeneca (NASDAQ:AZN) Wednesday night said that an updated analysis found that its COVID-19 vaccine is 76% effective at preventing symptomatic disease.

https://seekingalpha.com/news/3676053-updated-analysis-finds-astrazeneca-vaccine-76-effective-against-covid-19

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis

PUBLISHED22 March 2021

22 March 2021 07:00 GMT

79% vaccine efficacy at preventing symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

Comparable efficacy result across ethnicity and age,
with 80% efficacy in participants aged 65 years and over

Favourable reactogenicity and overall safety profile

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”

AstraZeneca will continue to analyse the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal.

Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.

AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The Phase III D8110C00001 trial is part of this funding agreement.

The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the Emergency Use Listing granted by the World Health Organization this accelerates the pathway to access in up to 142 countries through the COVAX Facility.

D8110C000011
The US Phase III trial, called D8110C00001, was led by AstraZeneca and funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) in collaboration with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Army Contracting Command, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial.

D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in 32,449 participants across 88 trial centres in the US, Peru and Chile. Trial participants aged 18 years or over who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus and COVID-19 were randomised in a 2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart.

To learn more about BARDA’s support for the COVID-19 pandemic response, visit medicalcountermeasures.gov.

To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus.

Please visit astrazeneca.com

AstraZeneca COVID-19 shot shows 79% efficacy;

Mar. 22, 2021 7:47 AM ET AstraZeneca PLC (AZN) By: Dulan Lokuwithana, SA News Editor40 Comments

Amid rare occurrences of blood clot formation following its inoculation, AstraZeneca (NASDAQ:AZN) today announced advanced trial data from the US study for its COVID-19 shot indicating an efficacy of ~79% at preventing symptomatic COVID-19.
https://seekingalpha.com/news/3674697-moderna-and-biontech-lower-after-astrazeneca-releases-us-trial-data-for-covid-19-shot
https://seekingalpha.com/symbol/AZN

AstraZeneca says vaccine is 76 percent effective in a new analysis after its use of data was questioned By Carolyn Y. Johnson

#AstraZeneca #CovidVaccine #MSNBC

AstraZeneca Covid Vaccine Found To Be Effective Against Severe Cases | Stephanie Ruhle | MSNBC

•Mar 22, 2021 MSNBC

Dr. Kavita Patel discusses the new data showing how effective the AstraZeneca Covid-19 vaccine is at preventing severe and fatal cases and why some may be hesitant to receive it. Aired on 03/22/2021.

AstraZeneca: US data shows vaccine effective for all adults

By MARIA CHENG and LAURAN NEERGAARD

https://apnews.com/article/us-data-shows-astrazeneca-vaccine-safe-all-ages-a73e711c7309be4444c65d5f9ae90c43

AstraZeneca Vaccine Is 79% Effective in U.S. Study

The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration.

https://www.nytimes.com/live/2021/03/22/world/covid-vaccine-coronavirus-cases

#CNBC #CNBCTV

AstraZeneca vaccine found to be 79% effective in U.S. trial

Mar 22, 2021 CNBC Television
The findings of a large U.S. trial have shown that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization. CNBC's Meg Tirrell reports. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi The findings of a large U.S. trial have shown that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization. The safety and efficacy analysis of the AstraZeneca vaccine, published Monday, was based on 32,449 participants across 88 trial centers in the U.S., Peru and Chile. Data from the late-stage human trial study reaffirms that the Oxford-AstraZeneca vaccine is safe and highly effective. By comparison, Moderna’s vaccine has been found to be more than 94% effective in preventing Covid and Pfizer-BioNTech’s vaccine was found to be 95% effective. AstraZeneca said it will continue to analyze the data and prepare for the primary analysis to be submitted to the U.S. Food and Drug Administration for emergency use authorization in the coming weeks. The results come shortly after several countries temporarily suspended the use of the shot following reports of blood clots in some vaccinated people. Health experts sharply criticized the move, citing a lack of data, while analysts expressed concern about the impact on vaccine uptake as the virus continues to spread. Germany, France, Italy and Spain are among those to have resumed use of the Oxford-AstraZeneca vaccine after Europe’s drug regulator said its initial investigation of possible side effects concluded the shot is safe and effective. The World Health Organization and the International Society on Thrombosis and Hemostasis have recommended that countries continue to use the Oxford-AstraZeneca vaccine. AstraZeneca said in a release Monday that an independent board identified no safety concerns related to the shot. It also conducted a specific review of blood clots as well as cerebral venous sinus thrombosis, an extremely rare blood clot in the brain, with the help of an independent neurologist. The data safety monitoring board “found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.” AstraZeneca to file for emergency use next month “We are thrilled by the results we have disclosed this morning,” Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit, told CNBC’s “Squawk Box” on Monday. “The plan is to file in the first half of April for the emergency use authorization and, of course, then it is in the hands of the FDA how fast they can decide about the approval. Assuming that the approval will take place in a fast way, we hope to deliver 30 million doses instantly after the EUA for Americans to get vaccinated,” Dobber said. When asked how AstraZeneca would tackle the prospect of lingering safety concerns following reports of blood clots in some vaccinated people, Dobber replied: “As always, and I think I speak on behalf of all manufacturers, patient safety is our number one priority.” “It was very pleasing to see that even with a magnifying glass the data safety monitoring board didn’t see any imbalance between the vaccinated group and the placebo group. So, that gives us a lot of confidence.”

Tecentriq ® (atezolizumab)

Sunday, Mar 21, 2021

Pivotal Phase III Study Shows Genentech’s Tecentriq Helped People With Early Lung Cancer Live Longer Without Their Disease Returning

First Phase III study to show that a cancer immunotherapy improves disease-free survival in people with resectable early stage lung cancer compared to best supportive care
Treating lung cancer early, before it has spread, may help prevent the disease from returning and therefore provide the best opportunity for a cure
Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency, and presented at an upcoming medical meeting

South San Francisco, CA -- March 21, 2021 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower010 study evaluating Tecentriq ® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomized Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.

About the IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

Tecentriq ® (atezolizumab)

About Tecentriq ® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

https://www.tecentriq.com/

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown, and
- their cancer tests positive for “high PD-L1”, and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
Tecentriq may also be used when their lung cancer:
- has spread or grown, and
- they have tried chemotherapy that contains platinum, and it did not work or is no longer working
- if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown

It is not known if Tecentriq is safe and effective in children.

Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.

For more information visit http://www.gene.com/cancer-immunotherapy.

For additional information about the company, please visit http://www.gene.com.

Genentech's Tecentriq meets late-stage lung cancer study main goal

Mar. 22, 2021 6:29 AM ETRoche Holding AG (RHHBY)By: Aakash Babu, SA News Editor1 Comment

Roche (OTCQX:RHHBY) company Genentech announces that the Phase III IMpower010 study evaluating Tecentriq (atezolizumab), compared with best supportive care (BSC), met its main goal of disease-free survival (DFS) in certain patients with non-small cell lung cancer (NSCLC) at the interim analysis.
https://seekingalpha.com/news/3674651-genentechs-tecentriq-meets-late-stage-lung-cancer-study-main-goal
https://seekingalpha.com/symbol/RHHBY

TECENTRIQ may work with your immune system to fight cancer

EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION)

PACIRA ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL NEW DRUG APPLICATION FOR EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) IN PEDIATRIC PATIENTS

PDF Version

-- EXPAREL is the first and only FDA-approved long-acting local analgesic for children aged six and over –
-- Conference call tomorrow at 8:30 a.m. ET --

PARSIPPANY, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.

EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION)

“The current standard of care for managing moderate-to-severe pain in children is opioids, which often come with unwanted severe and possibly life-threatening side effects in this vulnerable patient population,” said Dave Stack, Chairman and Chief Executive Officer at Pacira. “In line with our corporate mission to provide an opioid alternative to as many patients as possible, we are grateful for the opportunity to give clinicians and patients a new, safe and effective option for achieving long-lasting non-opioid pain control in children without the need for an indwelling catheter and pump.”

Since initial approval in 2011, more than 8 million patients have been treated with EXPAREL. With approximately one million pediatric procedures per year where opioids, catheters and pain pumps are the mainstay of postsurgical pain control, there is an urgent unmet need for opioid alternatives.

“There has been a significant gap in our pain control armamentarium as it relates to the ability to safely and effectively provide long-lasting non-opioid pain control for the pediatric surgical population,” said Christopher Tirotta, MD, Chief of Anesthesiology at Nicklaus Children's Hospital and an investigator in the pivotal PLAY study. “Traditional local anesthetics have not provided a duration of pain control that matches the time course of the most significant postsurgical pain, which has necessitated the reliance on opioids in an attempt to manage pain. With the addition of EXPAREL as an FDA-approved non-opioid option to provide prolonged pain control we are better equipped to treat our pediatric patients while reducing opioid exposure, and ultimately improving outcomes.”

The sNDA was based on the positive data from the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg. The PLAY study enrolled 98 patients to evaluate safety and the pharmacokinetics of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. Per FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of EXPAREL.

“Moderate-to-severe postsurgical pain is experienced by 40% of hospitalized children, and every scoliosis patient I treat surgically. Over and under treated pain in pediatric patients is a significant cause of morbidity after surgery,” said Peter Newton, MD, Chief of the Division of Orthopedics & Scoliosis at Rady Children's Hospital-San Diego and Clinical Professor at UC San Diego School of Medicine. “Opioids are responsible for 50% of postsurgical respiratory failure events in children, and often cause unpleasant side effects delaying a patient’s recovery after surgery. This FDA approval is a remarkable victory for pediatric patients and their families and paves the way for opioid-minimizing pain management protocols in children undergoing surgery.”

About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

https://www.pacira.com/

FDA OKs expanded use of Pacira's Exparel in pediatric patients

Mar. 23, 2021 4:12 AM ET

Pacira BioSciences, Inc. (PCRX)

By: Mamta Mayani, SA News Editor

The FDA has approved Pacira BioSciences' (NASDAQ:PCRX) supplemental new drug application (sNDA) seeking expansion of the Exparel label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia.
https://seekingalpha.com/news/3675071-fda-oks-expanded-use-of-paciras-exparel-in-pediatric-patients
https://seekingalpha.com/symbol/PCRX

EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Mar 20, 2021

Insulet’s Omnipod® 5 Automated Insulin Delivery System Improves Clinical Outcomes in Type 1 Diabetes

ACTON, Mass.--(BUSINESS WIRE)--Mar. 20, 2021-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced positive results from the first pivotal trial for the Omnipod® 5 Automated Insulin Delivery System. Omnipod 5, the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting and a leading forum for endocrinology research and clinical care worldwide.

Omnipod 5 System Pivotal Study Overview

Insulet presented its data in two groups of type 1 diabetes patients: 128 adults and adolescents between 14 and 70 years old, and 112 children age 6 to 13.9 years. The participants used the Omnipod 5 System at home for a period of 3 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections.

The Omnipod 5 System showed a significant increase in time in range (70-180 mg/dL) in the adults and adolescents, from 65% to 74%, or an additional 2.2 hours per day, and an overall reduction of HbA1c from 7.16% to 6.78%. Participants also saw a decrease in mean glucose from 161 to 154 mg/dL. Median time below 70 mg/dL improved from 2.0 to 1.1%. At a target glucose of 110 mg/dL, subjects achieved 76% time in range.

In children, time in range improved from 53% to 68%, corresponding to an additional 3.7 hours per day in target range. Additionally, HbA1c improved from 7.67% to 6.99% and the mean glucose level decreased from 183 to 160 mg/dL. Median time below 70 mg/dL stayed remarkably low at 1.5%.

“The daily management of type 1 diabetes is relentless,” said Jose S., father of a pediatric pivotal trial participant. “Caregivers make multiple decisions each day that profoundly affect their loved one’s wellness and safety. Insulet’s Omnipod 5 System reduces this burden by automating much of the decision making. It also provided me peace of mind by mitigating the threat of hypoglycemia.”

“It was remarkable how quickly every family learned to trust the automation, allowing people to sleep through the night for the first time in years,” said Professor Irl Hirsch, University of Washington. “The significant improvement in glycemic outcomes they achieved with the use of Omnipod 5, including the remarkably low rates of hypoglycemia, led to a tremendous reduction in the burden of care for so many.”

The Omnipod 5 System received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The Company expects to launch Omnipod 5 in limited release during the first half of 2021.

For more information, please visit: www.insulet.com and www.omnipod.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210320005001/en/

https://www.insulet.com/

Insulet’s insulin delivery system shows promise in pivotal trial

Mar. 22, 2021 6:10 AM ET

Insulet Corporation (PODD)

By: Aakash Babu, SA News Editor

Insulet (NASDAQ:PODD) announces positive results from the first pivotal trial for the company's Omnipod 5 Automated Insulin Delivery System.

https://seekingalpha.com/news/3674641-insulets-insulin-delivery-system-shows-promise-in-pivotal-trial

https://seekingalpha.com/symbol/PODD

Meet the Omnipod DASH® Insulin Management System

https://www.omnipod.com/new-to-omnipod

Meet the Omnipod DASH® Insulin Management System

KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma

March 23, 2021 6:45 am EST

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; p<0.0001) versus FU and cisplatin alone.The ORR, an additional efficacy outcome measure, was 45% (95% CI, 40-50) for patients who received KEYTRUDA plus FU and cisplatin and 29% (95% CI, 25-34) for those who received FU and cisplatin alone (p<0.0001).

Data Supporting the Approval

The approval was based on data from KEYNOTE-590 (ClinicalTrials.gov, NCT03189719), a multicenter, randomized, placebo-controlled trial that enrolled 749 patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation. Patients were randomized (1:1) to receive either KEYTRUDA (200 mg on Day 1 every three weeks) or placebo (on Day 1 every three weeks) in combination with cisplatin (80 mg/m2 on Day 1 every three weeks for up to six cycles) plus FU (800 mg/m2 per day on Days 1 to 5 every three weeks, or per local standard for FU administration, for up to 24 months); all study medications were administered via intravenous infusion.

Randomization was stratified by tumor histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia) and Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0 vs. 1).

Treatment with KEYTRUDA or chemotherapy continued until unacceptable toxicity or disease progression. Patients could be treated with KEYTRUDA for up to 24 months in the absence of disease progression. The major efficacy outcome measures were OS and PFS, as assessed by the investigator according to RECIST v1.1 (modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ). The study pre-specified analyses of OS and PFS based on squamous cell histology, Combined Positive Score (CPS) ≥10, and in all patients. Additional efficacy outcome measures were ORR and duration of response (DOR), according to modified RECIST v1.1, as assessed by the investigator.

KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

https://www.keytruda.com/

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck’s Patient Support Program for KEYTRUDA

Merck is committed to helping provide patients and their caregivers support throughout their treatment with KEYTRUDA. The KEY+YOU Patient Support Program provides a range of resources and support. For further information and to sign up, eligible patients may call 85-KEYTRUDA (855-398-7832) or visit www.keytruda.com.

For more information, visit www.merck.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005359/en/

Merck’s Keytruda authorized for a new indication in esophageal cancer

Mar. 23, 2021 11:22 AM ET

Merck & Co., Inc. (MRK)

By: Dulan Lokuwithana, SA News Editor2 Comments

Merck (MRK -1.2%) announced that the FDA has approved Keytruda for the treatment of a group of patients with locally advanced or metastatic esophageal or gastroesophageal junction (“GEJ”) carcinoma.
https://seekingalpha.com/news/3675276-mercks-keytruda-authorized-for-a-new-indication-in-esophageal-cancer
https://seekingalpha.com/symbol/MRK

Pemazyre® (pemigatinib)

Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene, Worsening After Cancer Chemotherapy

March 23, 2021

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WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy.

Pemazyre® (pemigatinib)

About FIGHT-202

The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.

About Pemazyre® (pemigatinib)

Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test9. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is marketed by Incyte in the United States and will be marketed by Incyte in Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

Additionally, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a trademark of Incyte Corporation.

https://www.pemazyre.com/

For additional information on Incyte, please visit Incyte.com and follow @Incyte.

For more information on Incyte Biosciences Japan G.K., please visit Incyte.jp.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005530/en/

Incyte's Pemazyre OK'd in Japan for bile duct cancer

Mar. 23, 2021 6:40 AM ET

Incyte Corporation (INCY)

By: Mamta Mayani, SA News Editor

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Incyte's (NASDAQ:INCY) Pemazyre, a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with FGFR2 fusion gene, worsening after cancer chemotherapy.
https://seekingalpha.com/news/3675094-incytes-pemazyre-okd-in-japan-for-bile-duct-cancer
https://seekingalpha.com/symbol/INCY

Vosoritide

BioMarin Announces Oral Presentation at ENDO2021, the Endocrine Society's Annual Meeting, with Data Demonstrating 2 Years of Treatment Benefit in Children with Achondroplasia Treated with VosoritideHeight Gain is Maintained in 2nd Year of Treatment

Mar 20, 2021

SAN RAFAEL, Calif., March 20, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that data from the open-label long-term extension of the Phase 3 study of 15 µg/kg dose of vosoritide was presented at an oral presentation at ENDO21, the Endocrine Society's Annual Meeting by Professor Ravi Savarirayan, M.B., B.S., M.D., clinical investigator from the Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne, Parkville, Victoria. Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for the treatment of achondroplasia, the most common form of disproportionate short stature in humans.

The data from the open-label extension presented at ENDO21 showed that children maintained an increase in Annual Growth Velocity (AGV) through the second year of continuous treatment with vosoritide. Children who received two years of vosoritide therapy had a baseline mean AGV of 4.28 cm/year. After one year of treatment, mean AGV was 5.71 cm/year and after the second year mean AGV was 5.65 cm/year, demonstrating sustained restoration of a major portion of the growth deficit in achondroplasia through the second year of treatment. Children also had an improved height z-score, which is a measure of height relative to that of a similar population of average height.

In the children who were crossed over from placebo to vosoritide in the open-label extension arm, similar efficacy after one year was observed compared to children who received treatment with vosoritide after one year. Children who were crossed over to treatment had a baseline mean AGV of 3.99 cm/year. After one year of treatment, mean AGV was 5.57 cm per year.

Retention of subjects on treatment was high with 93% of patients originally randomized to receive vosoritide remaining on treatment two years later.

Vosoritide Safety

The 2-year data demonstrated that vosoritide, administered at 15ug/kg/day was generally well tolerated with no new safety findings. The majority of adverse events (AEs) were mild and no serious adverse events were reported as study drug-related. Injection site reactions were the most common drug-related AEs, and all were transient. There were no AEs related to disproportionate bone growth or bone pathology. No clinically significant blood pressure decreases or new safety findings were observed.

For additional information, please visit www.biomarin.com.

BioMarin presents data supporting long-term benefit of vosoritide in achondroplasia

Mar. 21, 2021 12:09 AM ET

BioMarin Pharmaceutical Inc. (BMRN)

By: Dulan Lokuwithana, SA News Editor

BioMarin Pharmaceutical (NASDAQ:BMRN) has announced new Phase 3 data from an open-label long-term extension study to support the lasting treatment benefit of vosoritide in children with achondroplasia. https://seekingalpha.com/news/3674615-biomarin-presents-data-for-long-term-benefit-of-vosoritide-in-achondroplasia https://seekingalpha.com/symbol/BMRN

Vosoritide is an investigational analog of C-type Natriuretic Peptide (CNP) under evaluation for the treatment of children with achondroplasia, the most common form of skeletal dysplasia.

biotecMAX™ January/ February/March 2021 Insight

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study

March 19, 2021 6:45 am EST

KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of Death by 38%, With a Median Overall Survival of 18.3 Months Versus 11.4 Months With Chemotherapy Regardless of Mismatch Repair Status

First Results From Pivotal KEYNOTE-775/Study 309 Trial Presented at Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the first presentation of investigational data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial in an oral plenary session (Plenary Session #10191) at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer. The trial evaluated the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210319005069/en/

Results were similar across the all-comer population and the pMMR subgroup. In the pMMR subgroup, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI: 0.50-0.72]; p<0.0001), with a median PFS of 6.6 months (95% CI: 5.6-7.4; number of events=247) versus 3.8 months (95% CI: 3.6-5.0; number of events=238) for patients who received TPC. KEYTRUDA plus LENVIMA reduced the risk of death by 32% (HR=0.68 [95% CI: 0.56-0.84]; p=0.0001), with a median OS of 17.4 months (95% CI: 14.2-19.9; number of events=165) versus 12.0 months (95% CI: 10.8-13.3; number of events=203) for patients who received TPC. The secondary endpoint of ORR was 30.3% (95% CI: 25.5-35.5), with a CR rate of 5.2% and a PR rate of 25.1%, for patients who received KEYTRUDA plus LENVIMA versus 15.1% (95% CI: 11.5-19.3), with a CR rate of 2.6% and a PR rate of 12.5%, for patients who received TPC (ORR difference versus TPC: 15.2 percentage points; p<0.0001). For patients who responded, the median DOR was 9.2 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.

In the all-comer population, in the KEYTRUDA plus LENVIMA arm (n=406), treatment-emergent adverse events (TEAEs) of any grade led to discontinuation of KEYTRUDA in 18.7% of patients, of LENVIMA in 30.8% of patients, and of both in 14.0% of patients. In the TPC arm (n=388), TEAEs of any grade led to discontinuation of chemotherapy in 8.0% of patients. Grade 5 TEAEs of any cause occurred in 5.7% of patients in the KEYTRUDA plus LENVIMA arm and in 4.9% of patients in the TPC arm. Grade ≥3 TEAEs occurred in 88.9% of patients in the KEYTRUDA plus LENVIMA arm and in 72.7% of patients in the TPC arm. In the KEYTRUDA plus LENVIMA arm, the most common TEAEs of any grade occurring in at least 25% of patients were hypertension (64.0%), hypothyroidism (57.4%), diarrhea (54.2%), nausea (49.5%), decreased appetite (44.8%), vomiting (36.7%), weight decrease (34.0%), fatigue (33.0%), arthralgia (30.5%), proteinuria (28.8%), anemia (26.1%), constipation (25.9%) and urinary tract infection (25.6%). In the TPC arm, the most common TEAEs of any grade occurring in at least 25% of patients were anemia (48.7%), nausea (46.1%), neutropenia (33.8%), alopecia (30.9%), and fatigue (27.6%). Median treatment duration was 231 days (range: 1-817) with KEYTRUDA plus LENVIMA and 104.5 days (range: 1-785) with TPC.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administration’s (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

KEYNOTE-775/Study 309 Trial Design (Plenary Session #10191)

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following one prior platinum-based regimen in any setting. The dual primary endpoints are PFS, as assessed by BICR per RECIST v1.1, and OS. Select secondary endpoints include ORR, as assessed by BICR per RECIST v1.1, and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were pMMR, and 130 patients had tumors that were dMMR. Patients were randomized 1:1 to receive:

KEYTRUDA (200 mg intravenously [IV] every three weeks for up to 35 cycles [approximately two years]) in combination with LENVIMA (20 mg orally once daily); or
Chemotherapy treatment of physician’s choice (TPC) of either doxorubicin (60 mg/m2 IV every three weeks for up to a maximum cumulative dose of 500 mg/m2) or paclitaxel (80 mg/m2 IV on a 28-day cycle [three weeks of receiving weekly paclitaxel and one week of not receiving paclitaxel]).

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

https://www.keytruda.com/

How KEYTRUDA + LENVIMA may help

KEYTRUDA and LENVIMA are prescribed in combination to help treat your advanced endometrial cancer. Learn more about your treatment.

Results from a clinical trial

https://www.keytrudalenvima.com/advanced-endometrial-cancer/

http://www.lenvima.com/

About LENVIMA® (lenvatinib) Capsules

LENVIMA® (lenvatinib) is a kinase inhibitor that is indicated:

For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC)
In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
In combination with KEYTRUDA, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

LENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

What is LENVIMA?

LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.

LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing
LENVIMA is used along with another medicine called everolimus to treat advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anti-cancer medicine
LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery

It is not known if LENVIMA is safe and effective in children.

http://www.lenvima.com/

Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.

About the Merck and Eisai Strategic Collaboration

In March 2018, Eisai and Merck, known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck’s anti-PD-1 therapy KEYTRUDA.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.

For more information, visit www.merck.com

For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.eu (for Europe, Middle East, Africa),

Merck's Keytruda combo shines in late-stage endometrial cancer study

Mar. 19, 2021 7:06 AM ET Merck & Co., Inc. (MRK) By: Aakash Babu, SA News Editor

Merck (NYSE:MRK) announces that it's late-stage study testing the combination of its blockbuster cancer drug Keytruda with tyrosine kinase inhibitor LENVIMA in certain patients with endometrial cancer, met the main goals.

https://seekingalpha.com/news/3674343-mercks-keytruda-combo-shines-in-late-stage-endometrial-cancer-study

https://seekingalpha.com/symbol/MRK

https://us.eisai.com/who-we-are/collaboration

How KEYTRUDA + LENVIMA may help KEYTRUDA and LENVIMA are prescribed in combination to help treat your advanced endometrial cancer. Learn more about your treatment. Results from a clinical trial

PONVORY™ (ponesimod)

Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain LesionsHead-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide
PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator
Approval follows more than 10 years of cumulative data demonstrating the treatment’s efficacy and safety

TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.3,4,5

PONVORY™ also prevented disability from worsening for most people. Nine in 10 PONVORY™-treated patients did not have worsening of 3-month disability, and PONVORY™ showed a numerical benefit in delaying disability progression. The difference in rates of disability progression was not statistically significant between the PONVORY™ and teriflunomide groups.3

About the Phase 3 Study8
The Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial was a head-to-head, prospective, multicenter, randomized, double-blind Phase 3 study comparing efficacy, safety and tolerability of PONVORY™ 20 mg versus teriflunomide 14 mg in adults with relapsing MS. The primary endpoint of the study, which included 1,133 participants, was the annualized relapse rate (ARR) from baseline through the study period. The study included several other important efficacy endpoints, including the number of new Gd-enhancing T1 lesions from baseline to Week 108, the number of new or enlarging T2 lesions from baseline to Week 108, and the time to 3-month and 6-month confirmed disability progression.

PONVORY™ (ponesimod)

About PONVORY™
PONVORY™ (ponesimod) is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, indicated to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ is believed to work by keeping immune cells called lymphocytes out of the blood by trapping them in the lymph nodes.3 The way PONVORY™ exerts therapeutic effects in MS is unknown, but may help keep the lymphocytes out of the central nervous system, where they could cause damage.3

PONVORY™ does not require genetic testing or first-dose cardiac monitoring for most patients. Because initiation of PONVORY™ treatment results in a decrease in heart rate, first-dose monitoring is recommended in patients with certain preexisting cardiac conditions.3

It is not known if PONVORY™ is safe and effective in children.

Janssen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ponesimod for treatment of adults with relapsing multiple sclerosis in Q1 2020, which is currently under review.

A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.

Please see full Prescribing Information and Medication Guide.

Learn more at www.janssen.com.

FDA approves Johnson & Johnson's multiple sclerosis drug ponesimod

Mar. 19, 2021 8:35 AM ET

Johnson & Johnson (JNJ)

By: Jonathan M Block, SA News Editor1 Comment

The FDA has approved Johnson & Johnson's (NYSE:JNJ) oral therapy Ponvory (ponesimod) for relapsing multiple sclerosis.

https://seekingalpha.com/news/3674381-fda-approves-johnson-johnson-multiple-sclerosis-drug-ponvory-ponesimod

https://seekingalpha.com/symbol/JNJ

Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions Mar 19, 2021 United States Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator Approval follows more than 10 years of cumulative data demonstrating the treatment’s efficacy and safety TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.3,4,5

Mavacamten

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

03/19/2021CATEGORY:

Corporate/Financial News

U.S. FDA has assigned a target action date of January 28, 2022

Application based on results from the Phase 3 EXPLORER-HCM trial

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 28, 2022.

Mavacamten

Mavacamten is an investigational therapy that is not approved for use in any country.

About Mavacamten

Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is thought to work by reducing cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility, and increased diastolic compliance.

About EXPLORER-HCM

The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III), obstructive hypertrophic cardiomyopathy. All participants had measurable left ventricular outflow tract (LVOT) gradient (resting and/or provoked) ≥50 mmHg at baseline.

The primary endpoint for EXPLORER-HCM was a composite functional analysis designed to capture mavacamten’s effect on both symptoms and function. Secondary endpoints were changes from baseline to week 30 in postexercise LVOT gradient, pVO2, proportion of patients with at least one NYHA class improvement, and measures of patientreported outcomes. Additional endpoints included changes from baseline to Week 30 in echocardiographic indices, circulating biomarkers, cardiac rhythm patterns and accelerometry.

For more information about Bristol Myers Squibb, visit us at BMS.com

FDA accepts Bristol Myers Squibb's mavacamten NDA for review

Mar. 19, 2021 7:23 AM ET

Bristol-Myers Squibb Company (BMY)

By: Aakash Babu, SA News Editor

Bristol Myers Squibb (NYSE:BMY) announces that the U.S. FDA has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy ((oHCM)), with an action date of January 28, 2022.

https://seekingalpha.com/news/3674352-fda-accepts-bristol-myers-squibbs-mavacamten-nda-for-review

https://seekingalpha.com/symbol/BMY

FDA Accepts Bristol-Myers' Mavacamten Application In Inherited Heart Disease For Review Vandana Singh , Benzinga Staff Writer March 19, 2021 7:52am The FDA has accepted for review Bristol-Myers Squibb Co's (NYSE: BMY) marketing application for mavacamten for symptomatic obstructive hypertrophic cardiomyopathy. The FDA has assigned a goal date of January 28, 2022. Hypertrophic cardiomyopathy is a disease in which the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. Mavacamten is an allosteric modulator of cardiac myosin that reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation. Price Action: BMY shares are up 0.

KEYTRUDA® (pembrolizumab)

European Commission Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

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March 17, 2021 7:00 am EST

KEYTRUDA as Monotherapy Now Approved for Adult and Pediatric Patients Aged 3 years and Older with Relapsed or Refractory cHL Who Have Failed Autologous Stem Cell Transplant (ASCT) or After Two or More Lines of Therapy When ASCT is Not a Treatment Option

First Pediatric Indication for KEYTRUDA in the European Union

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; p=0.0027) and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV. The approval is also based on supportive data from an updated analysis of the KEYNOTE-087 trial; KEYNOTE-087 was the basis for the 2017 EC approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed ASCT and BV or who are transplant ineligible and have failed BV. This approval is the first pediatric approval for KEYTRUDA in the European Union (EU).

KEYTRUDA® (pembrolizumab)

A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER

IT’S TRU. KEYTRUDA.

SELECT A TYPE OF CANCER

https://www.keytruda.com/

The approval was based on data from KEYNOTE-204 (NCT02684292), a randomized, open-label, active-controlled study conducted in 304 patients with relapsed or refractory cHL.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210317005185/en/

For more information, visit www.merck.com

EC OKs expanded use of Merck’s Keytruda in classical hodgkin lymphoma

Mar. 17, 2021 8:07 AM ET Merck & Co., Inc. (MRK) By: Mamta Mayani, SA News Editor1 Comment

The European Commission (EC) has approved an expanded label for Merck's (NYSE:MRK) Keytruda, an anti-PD-1 therapy, as monotherapy for the treatment of patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplan

https://seekingalpha.com/news/3673536-ec-oks-expanded-use-of-mercks-keytruda-in-classical-hodgkin-lymphoma

https://seekingalpha.com/symbol/MRK

ARCALYST ® (rilonacept)

Kiniksa Announces FDA Approval of ARCALYST ® (rilonacept) for Recurrent Pericarditis

PDF Version

March 18, 2021

- ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis -
- Commercial launch expected in April 2021 -
- Kiniksa launches Kiniksa One Connect™ patient support program -
- Conference call and webcast scheduled for 5:30 p.m. EDT today -

HAMILTON, Bermuda, March 18, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced the U.S. Food and Drug Administration (FDA) approved ARCALYST ® (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The commercial launch is expected in April 2021.

“The approval of ARCALYST in recurrent pericarditis offers patients the first and only FDA-approved therapy for this devastating disease and also represents a transformational event for Kiniksa,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “I would like to thank the recurrent pericarditis community and specifically acknowledge the exceedingly dedicated patients, nurses, physicians and caregivers who participated in the clinical trials as well as the Kiniksa team whose absolute focus on patients made this possible. We look forward to launching ARCALYST for recurrent pericarditis with the support of our experienced commercial and medical affairs teams and, importantly, providing this breakthrough therapy to patients suffering with this debilitating disease as quickly as possible.”

ARCALYST ® (rilonacept)

About ARCALYST
ARCALYST is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks IL-1α and IL-1β signaling. ARCALYST was discovered by Regeneron and is approved by the FDA for recurrent pericarditis, CAPS, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and DIRA. The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.

About RHAPSODY
RHAPSODY is the global, randomized withdrawal design, pivotal Phase 3 clinical trial of ARCALYST in recurrent pericarditis. Eligible patients presented at screening with at least a third pericarditis episode, defined as at least 1 day with pericarditis pain of ≥ 4 on the 11-point Numerical Rating Scale (NRS) and a C-reactive protein (CRP) value ≥ 1 mg/dL within the 7-day period prior to first study drug administration. Patients could be receiving concomitant NSAIDs and/or colchicine and/or oral corticosteroid treatment in any combination. The study was comprised of 4 periods: a screening period; a single-blind run-in period during which patients received a loading dose of ARCALYST 320 mg injected subcutaneously (SC) followed by 160 mg SC weekly while background pericarditis medications were tapered and discontinued; a double-blind, placebo-controlled randomized withdrawal period during which clinical responders to ARCALYST were randomized 1:1 and received 160 mg SC weekly ARCALYST or placebo; and a long-term extension treatment period with up to 24 months of open-label ARCALYST 160 mg SC weekly. The primary efficacy endpoint was time-to-first pericarditis-recurrence in the randomized withdrawal period. The Clinical Endpoint Committee adjudicated all suspected pericarditis recurrences for inclusion in the primary efficacy endpoint analysis. Kiniksa will continue to follow patients in the long-term extension treatment period for up to 24 months. The co-principal investigators are Dr. Allan Klein of Cleveland Clinic and Dr. Massimo Imazio of the University of Torino, Italy. For more information, refer to ClinicalTrials.gov Identifier: NCT03737110.

About the ARCALYST License Agreement with Regeneron
In 2017, Regeneron granted Kiniksa an exclusive license to develop and commercialize ARCALYST worldwide, excluding Israel, Egypt, Turkey and select countries in the Middle East and North Africa. In the United States and Japan, Kiniksa’s license is for all indications other than those involving oncology and local administration to the eye or ear. Upon the approval of the supplemental Biologics License Application (sBLA) for ARCALYST in recurrent pericarditis, the scope of the license granted to Kiniksa automatically expanded to include DIRA and CAPS in the United States and Japan, and Kiniksa assumed the responsibility for sales and distribution of ARCALYST in these additional indications in the United States. Outside the United States and Japan, Kiniksa’s license is for all indications other than CAPS and certain periodic fever syndromes, DIRA, oncology, and local application to the eye or ear. Upon approval of ARCALYST in recurrent pericarditis, Kiniksa is obligated to make a $20 million milestone payment to Regeneron. Kiniksa and Regeneron will evenly split profits on sales of ARCALYST after deducting certain commercialization expenses, subject to specified limits.

https://www.arcalyst.com/

FDA Approval of ARCALYST® (rilonacept) for Recurrent Pericarditis March 18, 2021

https://investors.kiniksa.com/static-files/8659dd09-223e-4177-ad91-a361346ab7c5

Kiniksa wins FDA approval of Arcalyst for pericarditis; shares up 14% after-hours

Mar. 18, 2021 5:29 PM ET

Kiniksa Pharmaceuticals, Ltd. (KNSA)

By: Jonathan M Block, SA News Editor

The FDA has approved Kiniksa Pharmaceuticals' (NASDAQ:KNSA) Arcalyst (rilonacept) for recurrent pericarditis.

https://seekingalpha.com/news/3674266-kiniksa-wins-fda-approval-of-arcalyst-for-pericarditis-shares-up-14-afterhours

https://seekingalpha.com/symbol/KNSA

ARCALYST® (rilonacept) is the first and only FDA-approved treatment that targets IL-1 and is indicated for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older. ARCALYST, an IL-1 soluble decoy receptor, targets the underlying mechanism that drives inflammation in recurrent pericarditis.

NEXLETOL® (bempedoic acid) Tablet, ezetimibe and atorvastatin

Mar 17, 2021

NEXLETOL® (bempedoic acid) Tablet, ezetimibe and atorvastatin combination lowered bad cholesterol by 60.5% vs. placebo in Phase 2 study

- Results of bempedoic acid, ezetimibe and atorvastatin triple therapy study published in March issue of Atherosclerosis -

- Combining three orally administered once-daily LDL-C lowering medicines has not been previously studied, though combination therapy is common in other areas of cardiovascular medicine1 -

- Results of this Phase 2 study suggest oral combination therapy could play a role in helping more patients achieve guideline-specified LDL-C goals -

ANN ARBOR, Mich., March 17, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the results of a Phase 2 study evaluating the combination of NEXLETOL® (bempedoic acid) 180 mg Tablet, ezetimibe 10 mg and atorvastatin 20 mg in patients with hypercholesterolemia were published in Atherosclerosis, demonstrating reduction in low-density lipoprotein cholesterol (LDL-C) levels by 60.5% vs. placebo.2

NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

Indication and Limitation of Use
NEXLETOL and NEXLIZET are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined.

https://www.nexletol.com/

Please see the full Prescribing Information for NEXLETOL.
Please see the full Prescribing Information for NEXLIZET.

For more information, please visit www.esperion.com

Esperion's NEXLETOL combo shows promise in mid-stage cholesterol study

Mar. 17, 2021 4:14 PM ET

Esperion Therapeutics, Inc. (ESPR)

By: Aakash Babu, SA News Editor3 Comments

Esperion (NASDAQ:ESPR) announces results of a Phase 2 study evaluating the combination of NEXLETOL (bempedoic acid) 180 mg Tablet, ezetimibe 10 mg and atorvastatin 20 mg in patients with hypercholesterolemia showed reduction in low-density lipoprotein cholesterol (LDL-C) levels by 60.5% vs. placebo.

https://seekingalpha.com/news/3673779-esperions-nexletol-combo-shows-promise-in-mid-stage-cholesterol-study

https://seekingalpha.com/symbol/ESPR

DEVELOPMENT TIMELINE FOR BEMPEDOIC ACID1-6

https://esperion.com/science/bempedoic-acid/

What is NEXLETOL? NEXLETOL is a prescription medicine used, along with diet and other lipid-lowering medicines, in the treatment of adults who need additional lowering of “bad” cholesterol (LDL-C) and have: heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes high levels of LDL-C, and/or known cardiovascular disease It is not known if NEXLETOL can decrease problems related to high cholesterol, such as heart attacks or stroke.

NVX–CoV2373

Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials

Mar 11, 2021 at 4:02 PM EST Download PDF

- 100% protection against severe disease

- Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19

- Efficacy against variants confirmed in U.K. and South Africa

GAITHERSBURG, Md., March 11, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX–CoV2373, the company's vaccine candidate. The company also announced the complete analysis of its Phase 2b trial taking place in South Africa, with efficacy of 55.4% among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants. Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death. Both studies achieved their statistical success criteria. Today's final analyses build on the successful interim results announced in January 2021, adding substantially more COVID-19 cases and statistical power.

NVX–CoV2373

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

For more information, visit www.novavax.com

View original content:http://www.prnewswire.com/news-releases/novavax-confirms-high-levels-of-efficacy-against-original-and-variant-covid-19-strains-in-united-kingdom-and-south-africa-trials-301246019.html

Novavax (NVAX) shares continue to climb after robust COVID-19 vaccine data

Mar. 12, 2021 6:17 AM ET Novavax, Inc. (NVAX) By: Mamta Mayani, SA News Editor17 Comments

Novavax (NASDAQ:NVAX) soars nearly 20% in premarket trading after the final analysis of the U.K. trial showed that the vaccine was 96.4% effective against "mild, moderate, and severe disease caused by the original COVID-19 strain.
Vaccine efficacy was 86.3% against the fast-spreading U.K. variant (B.1.1.7/501Y.V1). Overall vaccine efficacy was 89.7%.
https://seekingalpha.com/news/3672149-novavax-nvax-shares-continue-to-climb-on-covid-19-vaccine-data
https://seekingalpha.com/symbol/NVAX

Novavax' vaccine 96% effective against original COVID-19 variant

Mar. 11, 2021 4:36 PM ET Novavax, Inc. (NVAX) By : Aakash Babu, SA News Editor 83 Comments

Novavax (NASDAQ:NVAX) is surging with a 14% gain in the post market session after reporting encouraging final analysis of the data from its late-stage COVID-19 trial conducted in the United Kingdom.
The vaccine candidate, NVX-CoV2373, has shown a final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain.
https://seekingalpha.com/news/3671951-novavax-vaccine-shows-high-level-of-efficacy-against-original-covid-19-variant
https://seekingalpha.com/symbol/NVAX

Coronavirus Vaccine Candidate Updates After assessing safety and immunogenicity in Phase 1/2 clinical trials, NVX-CoV2373 is currently in two pivotal Phase 3 studies to evaluate vaccine efficacy, safety and immunogenicity. We expect to announce initial interim data in Q1 2021. NVX-CoV2373 clinical trials have enrolled more than 30,000 volunteers around the globe. Learn more about our clinical trial enrollment and progress toward diversity demographics.

ALUNBRIG® (brigatinib)

Health Canada approves new indication for lung cancer treatment option ALUNBRIG®

Wed March 17, 2021 8:00 AM|Canada Newswire|About: TAK

First-line indication offers Canadians with advanced lung cancer new treatment options

TORONTO, March 17, 2021 /CNW/ - Takeda Canada Inc. is pleased to announce that Health Canada has issued ALUNBRIG® (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1 The approval is based on results from the phase 3 ALTA-1L trial which evaluated 275 patients and showed that once-daily ALUNBRIG® was superior to crizotinib on measures of efficacy and tolerability making it a promising first-line treatment option.2

"The approval of ALUNBRIG® is a significant step forward for Canadians battling advanced forms of lung cancer, who now have a new treatment option available in their fight against a devastating disease," says David Fyshe, Oncology Country Head, Takeda Canada. "We are proud of ALUNBRIG® clinical results demonstrating first-line treatment benefits. This new oncology indication directly supports Takeda's on-going commitments to uncover solutions for people living with cancer."

In 2018, ALUNBRIG® (brigatinib) was issued marketing authorization with conditions, pending the results of trials, as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).

About ALUNBRIG® (brigatinib)

ALUNBRIG® is a targeted medicine that blocks the action of the altered ALK gene to help shrink or slow cancer growth. ALUNBRIG® is administered orally, beginning with seven days of 90 mg once daily, followed by 180 mg once daily thereafter. ALUNBRIG® is now indicated as a monotherapy for the first-line treatment of adult patients with ALK+ locally advanced (not amenable to curative therapy) or metastatic NSCLC and as a monotherapy for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).1

ALUNBRIG® and the ALUNBRIG Logo® are registered trademarks of ARIAD Pharmaceuticals, Inc. (ARIA)

Additional information about Takeda Canada is available at www.takeda.com/en-ca.

Takeda’s lung cancer therapy approved for new indication in Canada

Mar. 17, 2021 3:45 PM ET

Takeda Pharmaceutical Company Limited (TAK)

By: Dulan Lokuwithana, SA News Editor1 Comment

The Canadian unit of Takeda Pharmaceutical (NYSE:TAK) has announced that the company has received marketing authorization from Health Canada for ALUNBRIG® (brigatinib tablets) as monotherapy for the first-line treatment for a certain group of patients with non-small cell lung cancer ("NSCLC").

https://seekingalpha.com/news/3673758-takedas-lung-cancer-therapy-approved-for-new-indication-in-canada

https://seekingalpha.com/symbol/TAK

Health Canada approves new indication for lung cancer treatment option ALUNBRIG®

March 17, 2021

First-line indication offers Canadians with advanced lung cancer new treatment options

TORONTO, ON – March, 17 2021 –– Takeda Canada Inc. is pleased to announce that Health Canada has issued ALUNBRIG® (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1 The approval is based on results from the phase 3 ALTA-1L trial which evaluated 275 patients and showed that once-daily ALUNBRIG® was superior to crizotinib on measures of efficacy and tolerability making it a promising first-line treatment option.2

https://www.takeda.com/en-ca/newsroom/news-releases/2021/health-canada-approves-new-indication-for-lung-cancer-treatment-option-alunbrig/

Uses of ALUNBRIG ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has a certain abnormal anaplastic lymphoma kinase (ALK) gene that has spread to other parts of your body. It is not known if ALUNBRIG is safe and effective in children.

Verzenio® (abemaciclib)

Lilly Presents Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

March 17, 2021Download PDFPRO data further support the monarchE results to date for Verzenio for the treatment of HR+, HER2- high risk early breast cancer
First disclosure of patient-reported outcomes for a Phase 3 study of a CDK4 & 6 inhibitor in the adjuvant setting for HR+, HER2- early breast cancer

INDIANAPOLIS, March 17, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced patient-reported outcomes (PRO) for the investigational use of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC). The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. In one analysis, the PRO data indicated that most patients (approximately 70-75%) in both arms reported being bothered "a little bit" or "not at all" by treatment-related side effects. This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

Verzenio® (abemaciclib)

Abstract # P008: Patients' quality of life and side effect perceptions in monarchE, a study of abemaciclib plus endocrine therapy in adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (Sara M. Tolaney)
- Accepted as ePoster – Adjuvant Systemic Therapy
- Available on-demand on March 10, 2021
- Selected for one of the three St. Gallen International Breast Cancer Conference Poster Awards 2021
Abstract # P013: Safety outcomes from monarchE: Phase 3 study of abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER-2-, node-positive, high risk, early breast cancer (Hope S. Rugo)
- Accepted as ePoster – Adjuvant Systemic Therapy
- Available on-demand on March 10, 2021

About Verzenio® (abemaciclib)
Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.

INDICATION
Verzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:

in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy
in combination with fulvestrant for women with disease progression following endocrine therapy
as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

https://www.verzenio.com/

Please see full Prescribing Information for Verzenio.

To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

To learn more about Lilly, please visit us at lilly.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-presents-patient-reported-outcomes-from-the-positive-phase-3-monarche-trial-for-verzenio-at-st-gallen-virtual-congress-2021-301248904.html

SOURCE Eli Lilly and Company

Lilly presents favorable patient reported outcomes in late-stage trial for breast cancer

Mar. 17, 2021 8:22 AM ET Eli Lilly and Company (LLY) By: Dulan Lokuwithana, SA News Editor1 Comment

Eli Lilly (NYSE:LLY) has announced the patient-reported outcomes (“PRO”) for the investigational use of Verzenio (abemaciclib) with adjuvant endocrine therapy (“ET”) in a contain category of patients with high-risk early breast cancer.

https://seekingalpha.com/news/3673543-lilly-presents-favorable-patient-reported-outcomes-in-late-stage-trial-for-breast-cancer

https://seekingalpha.com/symbol/LLY

Verzenio is a prescription medicine used to treat a type of breast cancer. It is a medicine you can take if: You have a type of breast cancer called HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2–negative) and the cancer has spread to other parts of the body (metastasized) Verzenio is given along with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, along with fulvestrant in women whose disease has progressed after hormonal therapy, or by itself in adults whose disease has progressed after hormone therapy and prior chemotherapy It is not known if Verzenio is safe and effective in children.

LIBTAYO® (CEMIPLIMAB)

March 15, 2021 at 2:00 AM EDT

PHASE 3 TRIAL OF LIBTAYO® (CEMIPLIMAB) MONOTHERAPY IN ADVANCED CERVICAL CANCER STOPPED EARLY FOR POSITIVE RESULT ON OVERALL SURVIVAL

TARRYTOWN, N.Y. and PARIS, March 15, 2021 /PRNewswire/ --

Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy

Trial enrolled patients with advanced cervical cancer regardless of PD-L1 status

Fourth cancer type where Libtayo has positive pivotal data; first-in-class survival results in cervical cancer follow first-in-class pivotal results in advanced BCC and advanced CSCC

Regulatory submissions planned in 2021

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) monotherapy compared to chemotherapy, in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021.

LIBTAYO® (CEMIPLIMAB)

About Libtayo
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

In the U.S., Libtayo is approved for certain patients with advanced stages of CSCC, BCC and NSCLC with ≥50% PD-L1 expression. Outside of the U.S., Libtayo is approved for certain patients with advanced CSCC in the European Union and six other countries, including Australia, Brazil, the United Kingdom and Canada.

The generic name for Libtayo in its approved U.S. indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.

About Regeneron's VelocImmune® Technology
Libtayo was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Libtayo® (cemiplimab-rwlc), Dupixent® (dupilumab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb), Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) and Regeneron's antibody cocktail for COVID-19, which was recently granted Emergency Use Authorization (EUA) in the U.S.

What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

Libtayo is a prescription medicine used to treat people with a type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR"," ALK "or "ROS1" gene.

It is not known if Libtayo is safe and effective in children.

Please see accompanying full Prescribing Information, including Medication Guide.

https://www.libtayo.com/

View original content:http://www.prnewswire.com/news-releases/phase-3-trial-of-libtayo-cemiplimab-monotherapy-in-advanced-cervical-cancer-stopped-early-for-positive-result-on-overall-survival-301246954.html

SOURCE Regeneron Pharmaceuticals, Inc.

Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com)

Regeneron, Sanofi winds up late-stage Libtayo study after positive data in cervical cancer

Mar. 15, 2021 7:00 AM ET Regeneron Pharmaceuticals, Inc. (REGN) By: Mamta Mayani, SA News Editor1 Comment

Based on positive results on overall survival (OS), Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) will stop early, Phase 3 trial investigating Libtayo (cemiplimab) monotherapy compared to chemotherapy, in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
https://seekingalpha.com/news/3672496-regeneron-sanofi-winds-up-llibtayo-study-after-positive-data-in-cervical-cancer
https://seekingalpha.com/symbol/REGN
https://seekingalpha.com/symbol/SNY

https://www.libtayo.com/

What is LIBTAYO? LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation. LlBTAYO is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI) or cannot receive treatment with a HHI. LIBTAYO is a prescription medicine used to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC). LIBTAYO may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if LIBTAYO is safe and effective in children.

TREMFYA® (guselkumab)

New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years

Tue March 16, 2021 6:00 AM|PR Newswire

These data mark the first and only long-term Phase 3 study results for a selective interleukin (IL)-23 inhibitor therapy in PsA, which include impact on radiographic progression through two years

PR Newswire

SPRING HOUSE, Pa., March 16, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced long-term data from the Phase 3 DISCOVER-2a study showing that the skin clearance, joint symptom relief, and safety of TREMFYA® (guselkumab) previously demonstrated through 24 weeks and one year (Week 52) in adults with active psoriatic arthritis (PsA) continued through two years (Week 112).1,2 These findings also confirmed that the robust efficacy TREMFYA demonstrated in patients at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitisb and dactylitisc was also seen through Week 100.1-8 In addition, the extent of radiographic progressiond was studied through two years. These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021.1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO).9

TREMFYA® (guselkumab)

In addition, results showed 56 percent of TREMFYA q4w patients and 55 percent of TREMFYA q8w patients achieved at least 50 percent improvement in ACR score (utilizing NRI).2 Among patients who had clinically meaningful PsO at baseline, 62 percent of TREMFYA q4w patients and 55 percent of TREMFYA q8w patients achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0 (utilizing NRI).2

"PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and therefore, sustained control of this inflammation is important to physicians and patients," said Alyssa Johnsen, M.D., Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. "These long-term study results further bolster our confidence in the ability of TREMFYA to significantly improve the diverse manifestations of PsA over time."

Click to Tweet: New Phase 3 study shows efficacy and safety data at two years with Janssen's medicine in patients with active #PsA. Read more: http://bit.ly/3cEmmSY

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases.9,12

TREMFYA was approved in the U.S. for the treatment of adults with moderate to severe plaque PsO in July 2017 and in July 2020 for adults with active PsA.9 The PsA approval was based on results from DISCOVER-1 and DISCOVER-2, which showed TREMFYA reached each study's primary endpoint of ACR 20 response at 24 weeks.4,5 Complete study results were previously published in The Lancet.4,5

Previously announced DISCOVER-1 and DISCOVER-2 data showed TREMFYA demonstrated improvements in multiple clinical outcomes of PsA including joint symptoms, skin symptoms, soft tissue inflammation, physical function, axial-related disease, fatigue as measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale,l and low rates of radiographic progression at Week 52.3-9,13

About TREMFYA® (guselkumab)9
Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as PsO and PsA.28

TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who are candidates for systemic therapy (injections or pills) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA. It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.

Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. https://www.tremfya.com/

Learn more at www.janssen.com.

View original content to download multimedia:

http://www.prnewswire.com/news-releases/new-phase-3-data-show-first-in-class-tremfya-guselkumab-achieved-complete-skin-clearance-and-favorable-joint-efficacy-in-adult-patients-with-active-psoriatic-arthritis-psa-through-two-years-301248005.html

SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson

J&J's Tremfya shows efficacy in psoriatic arthritis study through two years

Mar. 16, 2021 6:41 AM ET Johnson & Johnson (JNJ)

By: Mamta Mayani, SA News Editor

Johnson & Johnson (NYSE:JNJ) unit, Janssen Pharmaceutical announces long-term data from Phase 3 DISCOVER-2 study evaluating Tremfya (guselkumab) in adults with active psoriatic arthritis (PsA) through two years (Week 112).
https://seekingalpha.com/news/3672990-jnjs-jnj-tremfya-shows-efficacy-in-late-stage-psoriatic-arthritis-study
https://seekingalpha.com/symbol/JNJ

WHAT IS TREMFYA® (guselkumab)? TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.

Maribavir

Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance)

March 15, 2021

More Than Three Times as Many Transplant Recipients With Confirmed Resistant Cytomegalovirus (CMV) Infection at Baseline Receiving the Investigational Drug Maribavir Achieved CMV Viremia Clearance Compared to Conventional Antiviral Therapies, Building on Previously Presented Results Supporting the Efficacy of Maribavir
Transplant Recipients Receiving Maribavir Experienced Lower Rates of Treatment-Related Neutropenia and Acute Kidney Injury Compared to Conventional Antiviral Therapies
Takeda Continues to Investigate Maribavir for the First-Line Treatment of CMV in Hematopoietic Cell Transplant Recipients in an Ongoing Phase 3 Clinical Trial

OSAKA, Japan, March 15, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) announced the results from a subgroup analysis of the Phase 3 TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir), which supported the efficacy results from the overall randomized population. More than three times as many (62.8%; 76/121) transplant recipients with confirmed genotypic resistant CMV infection at baseline treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment phase) compared to those treated with conventional antiviral therapies (20.3%, 14/69) (investigator assigned treatment; IAT consists of one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) (adjusted difference [95% CI]: 44.1% [31.3, 56.9]).1

Transplant recipients receiving maribavir exhibited lower incidence of treatment-related toxicities common with conventional antiviral therapies. Those receiving maribavir experienced lower rates of treatment-related neutropenia vs. valganciclovir/ganciclovir (1.7% [4/234] vs. 25% [14/56]) and acute kidney injury vs. foscarnet (1.7% [4/234] vs. 19.1% [9/47]). Incidence of any treatment-emergent adverse events (TEAEs) was 97.4% (228/234) for maribavir and 91.4% (106/116) for the conventional therapy group.1 The most common TEAEs in the maribavir group were dysgeusia (35.9%, 84/234), nausea (8.5%, 20/234) and vomiting (7.7%, 18/234).2 Incidence of TEAEs leading to study drug discontinuation was 13.2% (31/234) in the maribavir group and 31.9% (37/116) in the conventional therapy group.1 Two treatment-related serious TEAEs led to death (1 patient per treatment group).1

About Maribavir

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HCT. Maribavir is an investigational treatment that has not been approved for use by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or any other regulatory authorities. Maribavir is the only CMV antiviral drug that targets and inhibits the UL97 protein kinase and its natural substrates.16-19

Maribavir has been granted Orphan Drug Designation by the European Commission as a treatment of CMV disease in patients with impaired cell mediated immunity and by the FDA for treatment of clinically significant CMV viremia and disease in at-risk patients. Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease. The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy. Breakthrough Therapy Designation expedites the development and review of investigational treatments for serious conditions with preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy. These designations do not guarantee that the EMA or FDA will approve maribavir for the treatment of CMV infections in transplant patients, and the timing of any such approval is uncertain.

For more information, visit https://www.takeda.com.

Phase 3 analysis confirms efficacy of Takeda's maribavir in transplant recipients

Mar. 15, 2021 10:12 AM ET

Takeda Pharmaceutical Company Limited (TAK)

By: Jonathan M Block, SA News Editor1 Comment

A subgroup analysis of phase 3 data from Takeda's (NYSE:TAK) investigational antiviral maribavir in transplant recipients with refractory, with or without resistance (R/R), cytomegalovirus (CMV) infection/disease showed more than than three times as many (62.8%) patients with confirmed genotypic resistant CMV infection in the treatment group achieved CMV clearance at week 8 compared to those on conventional antiviral therapies (20.3%).

https://seekingalpha.com/news/3672646-phase-3-analysis-confirms-efficacy-of-takeda-maribavir-in-transplant-recipients

https://seekingalpha.com/symbol/TAK

Our Pipeline

biotecMAX™ January/ February/March 2021 Insight

COVID-19 vaccine Ad26.COV2.S

WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19

12 March 2021 News release Geneva

The World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and for COVAX roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday.

Mar 12, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization

Mar 11, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission

Mar 11, 2021

Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion

COVID-19 vaccine Ad26.COV2.S

WHO authorizes Johnson & Johnson vaccine for emergency use worldwide

Mar. 12, 2021 11:40 AM ET Johnson & Johnson (JNJ) By: Jonathan M Block, SA News Editor8 Comments

The World Health Organization (WHO) has placed Johnson & Johnson's (NYSE:JNJ) COVID-19 vaccine on a list of safe and effective emergency therapies for all countries.
The move follows yesterday's decision by the European Medicines Agency to provide a similar authorization for the vaccine.
https://seekingalpha.com/news/3672319-who-authorizes-johnson-johnson-vaccine-for-emergency-use-worldwide
https://seekingalpha.com/symbol/JNJ

J&J to make up to three billion COVID-19 vaccines in 2022: chief scientist

By Julie Steenhuysen and Ludwig Burger CHICAGO/FRANKFURT (Reuters)

https://news.yahoo.com/j-j-three-billion-covid-204345668.html

MARCH 15, 2021

Takeda and IDT Support Manufacturing of Johnson & Johnson’s COVID-19 Vaccine

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization Data have demonstrated vaccine protects against COVID-19 related hospitalization and death in broad geographic regions, including those with variants of significant concern1 Available on not-for-profit basis for emergency pandemic use Compatible with standard vaccine storage, distribution channels, enabling delivery to remote areas NEW BRUNSWICK, N.J., March 12, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.

bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together

Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

March 10, 2021

Download PDF- New data show therapy reduced risk of hospitalizations and death by 87 percent- Second positive Phase 3 trial readout for bamlanivimab and etesevimab together- Results support use of bamlanivimab 700 mg and etesevimab 1400 mg, the dose authorized in U.S. and several countries around the world

INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together "These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1400 mg. These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the National Institutes of Health's COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the U.S."

For more information about the use of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 in high-risk patients under the FDA's emergency use authorization, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921).

Patients and physicians can visit lillyantibody.com to learn more, including how to find a potential treatment location.

For media resources, including product images and fact sheets, please click here.

Authorized Use and Important Safety Information

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use

Bamlanivimab and etesevimab together and bamlanivimab alone are not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Benefit of treatment with bamlanivimab alone has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

About etesevimab
Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

About BLAZE-1
BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.

In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), bamlanivimab 2800 mg plus etesevimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo, and bamlanivimab 700 mg plus etesevimab 1400 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV-2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.

The study is ongoing with additional treatment arms.

To learn more about Lilly, please visit us at  www.lilly.com

View original content to download multimedia: http://www.prnewswire.com/news-releases/lillys-bamlanivimab-and-etesevimab-together-reduced-hospitalizations-and-death-in-phase-3-trial-for-early-covid-19-301243984.html

SOURCE Eli Lilly and Company

Lilly's (LLY) COVID-19 antibody combo reduced hospitalization and death by 87%

Mar. 10, 2021 8:22 AM ET Eli Lilly and Company (LLY) By: Mamta Mayani, SA News Editor 1 Comment

Eli Lilly (NYSE:LLY) announces new data from Phase 3 BLAZE-1 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events").
https://seekingalpha.com/news/3671153-lillys-covid-19-combo-therapy-reduced-covid-hospitalizationby-87https://www.abcellera.com/

AbCellera-discovered bamlanivimab combo shows promise in late-stage COVID-19 trial

Mar. 10, 2021 11:37 AM ET AbCellera Biologics Inc. (ABCL) By: Aakash Babu, SA News Editor1 Comment

AbCellera (ABCL +6.0%) announces that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly (NYSE:LLY), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by 87% in high-risk patients recently diagnosed with COVID-19.
https://seekingalpha.com/news/3671258-abcellera-discovered-bamlanivimab-combo-shows-promise-in-late-stage-covid-19-trial
https://seekingalpha.com/symbol/ABCL
https://seekingalpha.com/symbol/LLY

AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19

VIR-7831 (GSK4182136)

Vir Biotechnology and GSK Announce VIR-7831 Reduces Hospitalization and Risk of Death in Early Treatment of Adults with COVID-19

03/10/21 at 8:22 PM ESTPDF Version

– Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalization or death –

– Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries –

– Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants –

SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy.

VIR-7831 (GSK4182136)

COMET-ICE Clinical Trial Design
The multi-center, double-blind, placebo-controlled COMET-ICE trial is investigating VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 1 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States.

In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial. This part of the trial is assessing the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally.

For more information, please visit www.vir.bio.

For further information please visit www.gsk.com/about-us.

https://www.vir.bio/pipeline/#focus

Vir Bio, GSK's COVID-19 antibody drug reduces hospitalization, death by 85%,

Mar. 11, 2021 2:31 AM ET Vir Biotechnology, Inc. (VIR) By: Mamta Mayani, SA News Editor4 Comments

An evidence of profound efficacy was found in Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline's (NYSE:GSK) Phase 3 COMET-ICE trial evaluating VIR-7831 (GSK4182136) as monotherapy for early treatment of COVID-19 in adults at high risk of hospitalization.

https://seekingalpha.com/news/3671542-vir-bio-gsks-covid-19-antibody-drug-shows-efficacy

https://seekingalpha.com/symbol/VIR

https://seekingalpha.com/symbol/GSK

Vir Biotechnology Inc (VIR)

https://www.barchart.com/stocks/quotes/VIR/options?moneyness=allRows&view=sbs

Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)

REAL-WORLD EVIDENCE CONFIRMS HIGH EFFECTIVENESS OF PFIZER-BIONTECH COVID-19 VACCINE AND PROFOUND PUBLIC HEALTH IMPACT OF VACCINATION ONE YEAR AFTER PANDEMIC DECLARED

Thursday, March 11, 2021 - 06:45am

Dramatically lower COVID-19 disease incidence rates observed in individuals fully vaccinated with the Pfizer-BioNTech vaccine, based on real-world data gathered by the Israel Ministry of Health
Data suggest Pfizer-BioNTech vaccine prevents asymptomatic SARS-CoV-2 infection
Latest data analysis finds unvaccinated individuals were 44 times more likely to develop symptomatic COVID-19 and 29 times more likely to die from COVID-19
Findings represent the most comprehensive real-world evidence to date demonstrating the effectiveness of a COVID-19 vaccine
Data are of global importance to other countries as vaccination campaigns continue worldwide

JERUSALEM & NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program. These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. This comprehensive real-world evidence can be of importance to countries around the world as they advance their own vaccination campaigns one year after the World Health Organization (WHO) declared COVID-19 a pandemic.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210311005482/en/

Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)

About the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in a total of more than 60 countries. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in Israel, the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

In addition, to learn more, please visit us on www.Pfizer.com

For more information, please visit www.BioNTech.de.

Pfizer-BioNTech's COVID-19 vaccine shows 97% efficacy after second dose: Real-world evidence

Mar. 11, 2021 7:18 AM ET Pfizer Inc. (PFE) By: Mamta Mayani, SA News Editor4 Comments

The Israel Ministry of Health (MoH) announces that real-world evidence demonstrate dramatically lower incidence rates of COVID-19 in individuals fully vaccinated with the Pfizer (NYSE:PFE) - BioNTech (NASDAQ:BNTX) COVID-19 Vaccine (BNT162b2).

https://seekingalpha.com/news/3671611-pfizer-biontechs-covid-19-vaccine-shows-97-efficacy-after-second-dose

Welcome to BioNTechs’s COVID-19 information portal

https://biontech.de/covid-19

https://seekingalpha.com/symbol/PFE

https://seekingalpha.com/symbol/BNTX

Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared

https://investors.biontech.de/news-releases/news-release-details/real-world-evidence-confirms-high-effectiveness-pfizer-biontech

Yescarta®(axicabtagene ciloleucel)

March 05, 2021

U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

-- Yescarta is the First CAR T-Cell Therapy Approved for Indolent Follicular Lymphoma; Approval Marks the Third Indication for a Kite Cell Therapy --

-- 91 Percent of Patients Responded to Yescarta, and Median Duration of Response Was Not Yet Reached in the ZUMA-5 Trial --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, and marks the third approved indication for a Kite cell therapy.

More information is available at www.kitekonnect.com.

About Yescarta

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
https://www.yescarta.com/
Please see Important Facts about YESCARTA, including important warnings.
For more information on Kite, please visit www.kitepharma.com.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210305005624/en/

Gilead wins FDA approval for Yescarta in follicular lymphoma

Mar. 06, 2021 9:09 PM ET Gilead Sciences, Inc. (GILD) By: Dulan Lokuwithana, SA News Editor16 Comments

Kite, a unit of Gilead Sciences (NASDAQ:GILD), has announced that the FDA has granted approval for its T cell immunotherapy Yescarta (axicabtagene ciloleucel) for a certain category of adults with relapsed or refractory follicular lymphoma.
https://seekingalpha.com/news/3670089-gilead-wins-fda-approval-for-yescarta-in-follicular-lymphoma
https://seekingalpha.com/symbol/GILD

APPROVED USE YESCARTA is a treatment for your non-Hodgkin lymphoma. It is used when you have failed at least two other kinds of treatment. YESCARTA is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

NURTEC® ODT (rimegepant)

BIOHAVEN'S NURTEC® ODT APPROVED IN ISRAEL FOR ACUTE TREATMENT OF MIGRAINE

03/10/2021- NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT)- A single oral dose of NURTEC ODT 75 mg can provide fast pain relief and return patients to normal function within 60 minutes, and deliver sustained efficacy that lasts up to 2 days for many patients- 86 percent of patients treated with a single dose of NURTEC ODT did not use a migraine rescue medication within 24 hours

NEW HAVEN, Conn., March 10, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma announced today that NURTEC® ODT (rimegepant) was approved by the Israeli Ministry of Health for the acute treatment of migraine with and without aura in adults. NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT) approved for the acute treatment of migraine.

NURTEC® ODT (rimegepant)

About NURTEC ODT
NURTEC® ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.

The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Indication
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use
NURTEC ODT is not indicated for the preventive treatment of migraine.

https://www.nurtec.com/

Please click here for full Prescribing Information.

More information about Biohaven is available at www.biohavenpharma.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine-301244414.html

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

Biohaven's NURTEC ODT approved in Israel for acute treatment of migraine

Mar. 10, 2021 7:37 AM ET Biohaven Pharmaceutical Holding Company Ltd. (BHVN) By: Aakash Babu, SA News Editor

Biohaven Pharmaceutical (NYSE:BHVN) announces that NURTEC ODT (rimegepant) was approved by the Israeli Ministry of Health for the acute treatment of migraine with and without aura in adults.

https://seekingalpha.com/news/3671108-biohavens-nurtec-odt-approved-in-israel-for-acute-treatment-of-migraine

https://seekingalpha.com/symbol/BHVN

WHAT IS NURTEC ODT? Nurtec ODT (rimegepant) orally disintegrating tablets is a prescription medicine for the acute treatment of migraine attacks with or without aura in adults. Nurtec ODT is not used as a preventive treatment of migraine. It is not known if Nurtec ODT is safe and effective in children.

KEYTRUDA® (pembrolizumab)

Health Canada Approves KEYTRUDA® (pembrolizumab) as First-line Treatment for Adults with Metastatic Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

Mon March 8, 2021 7:00 AM|Canada Newswire|About: MRK

Approval Based on Significant Progression Free Survival Findings from Phase 3 KEYNOTE-177 Trial

KEYTRUDA® is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells.1
An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily.2

KIRKLAND, QC, March 8, 2021 /CNW/ - Merck (MRK), known as MSD outside the United States and Canada, today announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the first-line treatment, as monotherapy, for adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).3

KEYTRUDA® (pembrolizumab)

About KEYTRUDA®

KEYTRUDA® is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells.20 KEYTRUDA® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.21

KEYTRUDA® was first approved in Canada in 2015 and currently has 19 indications in several disease areas, including advanced renal cell carcinoma (RCC), bladder cancer, non-small cell lung carcinoma (NSCLC), classical Hodgkin lymphoma (cHL), melanoma and head and neck squamous cell carcinoma (HNSCC).22

For more information about our operations in Canada, visit www.merck.ca

Please see the product monograph for KEYTRUDA® (pembrolizumab) at:
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf.

https://www.keytruda.com/

https://seekingalpha.com/symbol/MRK

https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf

VENTANA ALK (D5F3) CDx Assay

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Tue March 9, 2021 1:00 AM|PR Newswire|About: CHGCY, RHHBY

-- ALK - anaplastic lymphoma kinase - is an important biomarker found in NSCLC, and targeted therapies have been shown to dramatically improve progression-free survival compared to the previous standard of care(2,3,4)

-- The VENTANA ALK (D5F3) CDx Assay(5) is now FDA approved as a companion diagnostic in four targeted treatments, providing more options to lung cancer patients

PR Newswire

TUCSON, Ariz., March 9, 2021 /PRNewswire/ -- Roche (RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Pfizer's drug LORBRENA® (lorlatinib). The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

VENTANA ALK (D5F3) CDx Assay

The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) and LORBRENA® (lorlatinib). The assay has been shown in studies to identify more NSCLC patients that may benefit from an anti-ALK target therapy than fluorescent in situ hybridisation (FISH) testing.6,7,8,9 The VENTANA ALK (D5F3) CDx Assay is available in the US for use on the BenchMark ULTRA and BenchMark XT immunohistochemistry/in situ hybridisation (IHC/ISH) slide staining instruments.

About the VENTANA ALK (D5F3) CDx Assay

VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer tissue stained with a BenchMark ULTRA or BenchMark XT automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) or LORBRENA® (lorlatinib) in the US.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This product is intended for in vitro diagnostic (IVD) use.

For more information, visit ALKIHC.com.

About LORBRENA

For more information on LORBRENA (lorlatinib), visit LORBRENA

https://www.lorbrena.com/

https://www.pfizer.com/https://www.chugai-pharm.co.jp/english/

https://www.roche.comhttps://seekingalpha.com/symbol/RHHBY

https://seekingalpha.com/symbol/CHGCY

FDA OKs expanded use of Roche's Ventalan ALK Assay in lung cancer

Mar. 09, 2021 2:34 AM ET Roche Holding AG (RHHBY) By: Mamta Mayani, SA News Editor

The FDA has approved Roche's (OTCQX:RHHBY) Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Pfizer's (NYSE:PFE) drug Lorbrena (lorlatinib).
https://seekingalpha.com/news/3670547-fda-oks-expanded-use-of-roches-ventalan-alk-assay-in-lung-cancer

VENTANA ALK (D5F3) CDx Assay

Valoctocogene Roxaparvovec,

BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia ARMAT Designation Granted by FDA During Bleeding Disorders Awareness Month

Mar 8, 2021

SAN RAFAEL, Calif., March 8, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. The FDA granted RMAT designation based on the potential of the valoctocogene roxaparvovec clinical data to address the unmet medical need within this population.

"We are encouraged that the FDA granted RMAT Designation to valoctocogene roxaparvovec. This designation confirms our belief in this treatment's potential to address unmet medical needs for people with hemophilia A at this time," said Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin. "We look forward to continuing a productive dialogue with the FDA around the RMAT designation, which provides options for the Agency to leverage data post approval, while also recognizing the agency's initial request to see two years of data from the Phase 3 study to evaluate the safety and efficacy of this investigational treatment option that could potentially provide a transformational treatment choice for the hemophilia community."

"During Bleeding Disorders Awareness Month, we applaud the FDA for its efforts to recognize the potential of cell and gene therapies to help people with hemophilia who have medical needs not currently addressed," said Leonard A. Valentino, MD, President & CEO of the National Hemophilia Foundation (NHF). "Established under the 21st Century Cures Act, RMAT designation has the potential to provide more treatment choices to people with bleeding disorders at a faster pace, which benefits the whole community. The FDA's RMAT designation is a critical program to advance the efficient development and regulatory review of regenerative medicine products that have the potential to address unmet needs," said the Alliance for Regenerative Medicine (ARM). "As the global voice of the regenerative medicine sector, ARM played a critical role in the creation of this pathway. The FDA has granted more than 50 RMAT designations to investigational products and in February approved an RMAT-designated product for the first time, illustrating the agency's commitment to advancing the development of regenerative medicines."

For additional information, please visit www.biomarin.com.

https://seekingalpha.com/news/3670215-biomarins-hemophilia-therapy-wins-fda-rmat-status

BioMarin's hemophilia therapy wins FDA RMAT status

Mar. 08, 2021 8:44 AM ET BioMarin Pharmaceutical Inc. (BMRN) By: Aakash Babu, SA News Editor

BioMarin Pharmaceutical (NASDAQ:BMRN) announces that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A.

https://seekingalpha.com/symbol/BMRN

Valoctocogene roxaparvovec is an investigational AAV5 gene therapy under regulatory review for the treatment of severe hemophilia A.

Moderna COVID-19 Vaccine)

Moderna Announces Supply Agreement to Provide 13 Million Doses of COVID-19 Vaccine Moderna to the Philippines

March 6, 2021 at 12:23 PM ESTPDF Version

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 6, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a supply agreement with the Government of The Philippines for 13 million doses of the COVID-19 Vaccine Moderna.

Under the terms of this agreement, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the Company will work with regulators to pursue necessary approvals prior to distribution.

A separate agreement with the Philippine Government and private sector for the supply of an additional 7 million doses is also anticipated. Moderna COVID-19 Vaccine)

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination).

View source version on businesswire.com: https://www.businesswire.com/news/home/20210306005014/en/

To learn more, visit www.modernatx.com.

Moderna to start variant-targeted COVID-19 vaccine trial next week

Mar. 05, 2021 3:37 PM ET Moderna, Inc. (MRNA) By: Dulan Lokuwithana, SA News Editor19 Comments

Moderna (MRNA -1.1%) is set to begin its first human study for the COVID-19 vaccine candidate targeting a new coronavirus strain as early as next week, The Wall Street Journal reports.https://seekingalpha.com/news/3670022-moderna-to-start-variant-targeted-covid-19-vaccine-trial-next-week
https://seekingalpha.com/symbol/MRNA
https://seekingalpha.com/news/3670114-moderna-to-supply-13m-doses-of-covid-19-vaccine-to-philippines

Baxter BioPharma Solutions and Moderna Announce Agreement for Fill/Finish Manufacturing of the Moderna COVID-19 Vaccine in the U.S.

March 8, 2021 at 9:00 AM ESTPDF Version

Agreement to perform fill/finish services for approximately 60–90 million doses in the U.S. this year
Manufacturing will take place at Baxter BioPharma Solutions’ Indiana facility

DEERFIELD, Ill., AND CAMBRIDGE, Mass..--(BUSINESS WIRE)--Mar. 8, 2021-- Baxter International Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that they have entered into an agreement for Baxter BioPharma Solutions to provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of the Moderna COVID-19 Vaccine in 2021. Baxter’s BioPharma Solutions business is a premier contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals, including vaccines.

https://investors.modernatx.com/news-releases/news-release-details/baxter-biopharma-solutions-and-moderna-announce-agreement

Moderna ropes in Baxter for fill/finish manufacturing of COVID-19 vaccine

Mar. 08, 2021 12:36 PM ET Baxter International Inc. (BAX) By: Dulan Lokuwithana, SA News Editor3 Comments

Baxter International (BAX +0.9%) has agreed to provide fill/finish sterile manufacturing services and supply packaging for ~60-90M doses of the COVID-19 vaccine developed Moderna (MRNA -3.5%).

https://seekingalpha.com/news/3670345-moderna-ropes-in-baxter-for-fillfinish-manufacturing-of-covid-19-vaccine

https://seekingalpha.com/symbol/BAX

https://seekingalpha.com/symbol/MRNA

Moderna Announces First Participants Dosed in Study Evaluating COVID-19 Booster Vaccine Candidates

March 10, 2021 at 4:09 PM EST PDF Version

Study to enroll 60 participants previously vaccinated with mRNA-1273 in Phase 2, to evaluate booster vaccine candidates against the B.1.351 variant first identified in South Africa

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 10, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participants have been dosed with the Company’s modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, in an amendment to the ongoing Phase 2 clinical study.

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-study-evaluating

Mar 5, 2021 at 1:35 pm ET First Study of Moderna's Variant-Targeted Vaccine May Start Next Week By Peter Loftus

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

March 06, 2021

Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI

– >98% of Treatment-Naïve Patients Achieved and Maintained Undetectable Viral Load with Biktarvy Through Four Years in the Open-Label Extension Phase of Two Phase 3 Studies –

– Treatment-Naïve Adults Reached and Maintained Undetectable Viral Load with Biktarvy for Certain Transmitted-Drug Resistance and with No Treatment-Emergent Resistance Through 144 Weeks –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new, long-term data from open-label extensions (OLE) of two Phase 3 studies (Study 1489 and Study 1490) of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), demonstrating the sustained efficacy and safety profile and no treatment-emergent resistance with Biktarvy for the treatment of HIV-1 in treatment-naïve adults. The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).

Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF)

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies /mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy.

https://www.biktarvy.com/

U.S. Prescribing Information for Biktarvy including BOXED WARNING, is available at www.gilead.com.

Gilead presented additional Biktarvy data at virtual CROI 2021, including findings from a 144-week analysis of the same Phase 3 studies (Study 1489 and Study 1490), which demonstrated that people living with HIV who received initial therapy with Biktarvy reached and maintained an undetectable viral load with no treatment-emergent resistance through 144 weeks (n=634). In a subgroup analysis of participants with transmitted-drug resistance (TDR, n=248) based on retrospective sequencing of baseline samples, Biktarvy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR (98% vs. 97%; as treated analysis).

“As a clinician, my goal is to initiate treatment immediately after diagnosis with a therapy that achieves and maintains virologic control over the long-term,” said Kimberly Workowski, MD, Professor of Medicine, Emory University. “The data presented at CROI highlight that Biktarvy can achieve long-term viral suppression at four years among a range of people living with HIV and supports further study for patients with certain transmitted drug-resistant HIV.”

The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. FDA, and the safety and efficacy of Biktarvy for this use has not been established. Please see below for the U.S. Indication and Important Safety Information for Biktarvy.

Biktarvy does not cure HIV or AIDS.

https://www.gilead.com/

Gilead announces new four year late-stage data for Biktarvy in HIV

Mar. 08, 2021 8:03 AM ET Gilead Sciences, Inc. (GILD) By: Dulan Lokuwithana, SA News Editor9 Comments

Gilead Sciences (NASDAQ:GILD) has announced new long-term data from two ongoing Phase 3 studies (Studies 1489 and 1490) of Biktarvy for HIV-1 in treatment-naïve adults.
https://seekingalpha.com/news/3670189-gilead-announces-new-four-year-late-stage-data-for-biktarvy-in-hiv
https://seekingalpha.com/symbol/GILD
View source version on businesswire.com: https://www.businesswire.com/news/home/20210306005010/en/

What is BIKTARVY®? BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 55 pounds. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Molnupiravir (EIDD-2801/MK-4482)

Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

March 6, 2021 12:01 am EST

The findings reported on a secondary objective to reduce time to negativity of infectious SARS-CoV-2 virus isolation from nasopharyngeal swabs from participants with symptomatic COVID-19

Primary and other secondary findings to be presented at an upcoming medical meeting

MIAMI & KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. These preliminary findings were presented today during Science SpotlightsTM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005610/en/

Molnupiravir (EIDD-2801/MK-4482)

About Molnupiravir

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.

For more information, visit www.merck.com

Merck announces positive mid-stage trial data for COVID-19 antiviral drug

Mar. 06, 2021 9:07 PM ET Merck & Co., Inc. (MRK) By: Dulan Lokuwithana, SA News Editor4 Comments

Merck (NYSE:MRK) and Ridgeback Biotherapeutics have announced that molnupiravir (EIDD-2801/MK-4482), their investigational oral antiviral agent against COVID-19, managed to speed up the time for the infectious agent to become negative in COVID-19 patients.
https://seekingalpha.com/news/3670088-merck-announces-positive-mid-stage-trial-data-for-covid-19-antiviral-drughttps:

MRK Merck & Co., Inc.

https://seekingalpha.com/symbol/MRK

https://ridgebackbio.com/

Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir The findings reported on a secondary objective to reduce time to negativity of infectious SARS-CoV-2 virus isolation from nasopharyngeal swabs from participants with symptomatic COVID-19 Primary and other secondary findings to be presented at an upcoming medical meeting

biotecMAX™ January/ February/March 2021 Insight

BLINCYTO® (Blinatumomab)

BLINCYTO® (Blinatumomab) Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation Chemotherapy In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

Phase 3 Results Published in The Journal of The American Medical Association
93% of Patients With Minimal Residual Disease (MRD) at Baseline Achieved MRD Negative Remission With BLINCYTO Versus 24% After Chemotherapy

THOUSAND OAKS, Calif., March 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

BLINCYTO® (Blinatumomab)

BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with BLINCYTO were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with BLINCYTO, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the BLINCYTO group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

About the 20120215 Study
Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial evaluating event-free survival after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell ALL. Study enrollment was terminated early in September 2019 due to encouraging efficacy in the BLINCYTO arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC) in accordance with a prespecified stopping rule. Key secondary endpoints included overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA and is being conducted in Australia and various countries in the EU and Latin America. Click here to read about the trial on ClinicalTrials.gov.

About BiTE® Technology
BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About BLINCYTO® (Blinatumomab)
BLINCYTO is a BiTE® (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:

relapsed or refractory B-cell precursor ALL in adults and children.
B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation

https://www.blincyto.com/

INDICATIONS

BLINCYTO® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy.

The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There are ongoing studies to confirm clinical benefit.

BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.

Amgen reports positive effect of Blincyto in children with lymphoblastic leukemia

Mar. 02, 2021 4:29 PM ET Amgen Inc. (AMGN) By: Dulan Lokuwithana, SA News Editor

Amgen (NASDAQ:AMGN) has announced that its immuno-oncology therapy Blincyto has significantly prolonged event-free survival compared with consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL).

https://seekingalpha.com/news/3668510-amgen-reports-positive-effect-of-blincyto-in-children-with-lymphoblastic-leukemia

https://seekingalpha.com/symbol/AMGN

INDICATIONS BLINCYTO® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy. The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There are ongoing studies to confirm clinical benefit. BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.

Actemra®/RoActemra® (tocilizumab)

Roche’s Actemra/RoActemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition

Systemic sclerosis (SSc) is a rare disease that affects about 2.5 million people worldwide
Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a progressive disease that can significantly impact lung function and can be life-threatening
In a global study, Actemra/RoActemra reduced the rate of progressive loss of lung function in people with SSc-ILD compared to placebo
The U.S. Food and Drug Administration previously granted Priority Review designation to Actemra/RoActemra for the treatment of SSc-ILD

Basel, 05 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Actemra®/RoActemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease. Actemra®/RoActemra® (tocilizumab)

About Actemra/RoActemra

Actemra/RoActemra was the first approved anti-IL-6 receptor biologic, and is available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX. Actemra/RoActemra IV and SC are also approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older. Actemra/RoActemra SC is approved globally for giant cell arteritis (GCA), and Actemra/RoActemra IV is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. Actemra/RoActemra was the first approved treatment for sJIA, GCA and CRS. Actemra SC is now approved in the U.S. for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition to the above-mentioned indications, in Japan Actemra IV is also approved for the treatment of Castleman’s disease and adult Still's disease, and the Actemra SC formulation is approved for Takayasu arteritis. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is approved in more than 110 countries worldwide. For more information, please visit www.roche.com.FDA OKs Roche's Actemra injection for regulating pulmonary function in SSc-ILD

Mar. 05, 2021 4:48 AM ETRoche Holding AG (RHHBY)By: Mamta Mayani, SA News Editor

Thursday, Mar 4, 2021

Genentech’s Actemra Becomes the First BiologThe FDA has approved Roche's (OTCQX:RHHBY) Actemra/RoActemra (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).https://seekingalpha.com/news/3669803-fda-oks-roches-actemra-for-regulating-pulmonary-function-in-ssc-ildhttps://seekingalpha.com/symbol/RHHBY

ic Therapy Approved by the FDA for Slowing the Rate of Decline in Pulmonary Function in Adults With Systemic Sclerosis-Associated Interstitial Lung Disease, a Rare, Debilitating Condition

Systemic sclerosis (SSc) is a rare disease that impacts up to 75,000 people in the United States
Approximately 80% of SSc patients may be affected by interstitial lung disease (ILD), a progressive disease that can significantly impact lung function and can be life-threatening
In a global study, Actemra reduced the rate of progressive loss of lung function in people with SSc-ILD compared to placebo
The U.S. Food and Drug Administration previously granted Priority Review designation to Actemra for the treatment of SSc-ILD

South San Francisco, CA -- March 4, 2021 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Actemra® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. Actemra is the first biologic therapy approved by the FDA for the treatment of the disease.://www.gene.com/media/press-releases/14897/2021-03-04/genentechs-actemra-becomes-the-first-bio

What does ACTEMRA treat? ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist. ACTEMRA is used to treat: Adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well Adults with giant cell arteritis (GCA) Adults with systemic sclerosis with early interstitial lung disease (SSc-ILD) Patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older Patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

bamlanivimab (LY-CoV555)

EMA issues advice on Lilly's bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

March 5, 2021Download PDFCHMP has completed a review of available data for both antibodies for the treatment of confirmed COVID-19
CHMP scientific opinion supports national decision-making within European Union (EU) member states on the use of the antibodies during a public health emergency before a formal marketing authorization is granted

INDIANAPOLIS, March 5, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3 of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. The opinion can now be considered by the EU member states when making decisions on the use of the therapies at a national level before a formal marketing authorization is issued. bamlanivimab (LY-CoV555)

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.https://seekingalpha.com/news/3670026-abcelleras-bamlanivimab-wins-emas-positive-recommendation

In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), bamlanivimab 2800 mg plus etesevimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV-2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll up to 3,300 participants. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.

View original content to download multimedia:http://www.prnewswire.com/news-releases/ema-issues-advice-on-lillys-bamlanivimab-ly-cov555-alone-and-administered-together-with-etesevimab-ly-cov016-for-the-treatment-of-confirmed-covid-19-in-the-european-union-301241579.html

SOURCE Eli Lilly and Company

Eli Lilly’s antibody combo wins positive opinion in Europe against COVID-19

Mar. 05, 2021 12:15 PM ETEli Lilly and Company (LLY)By: Dulan Lokuwithana, SA News Editor

Eli Lilly and Company (LLY +2.0%) announced that the European Medicines Agency has issued a positive opinion for its bamlanivimab alone and bamlanivimab/ etesevimab combination for the treatment of confirmed COVID-19.https://seekingalpha.com/symbol/LLY

AbCellera and Lilly to Co-develop Antibody Therapies for the Treatment of COVID-19

Tislelizumab

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Second- or Third-line Non-Small Cell Lung Cancer

March 5, 2021 at 8:30 AM EST

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 5, 2021-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that a supplemental Biologics License Application (sBLA) for anti-PD1 antibody tislelizumab was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for treatment in the second- or third-line setting of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy. Tislelizumab

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986). To learn more about BeiGene, please visit www.beigene.com

BeiGene's tislelizumab lung cancer sBLA accepted in China

Mar. 05, 2021 8:45 AM ETBeiGene, Ltd. (BGNE)By: Aakash Babu, SA News Editor

BeiGene (NASDAQ:BGNE) announces that a supplemental Biologics License Application ((sBLA)) for anti-PD1 antibody tislelizumab was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for treatment in the second- or third-line setting of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy.https://seekingalpha.com/news/3669897-beigenes-tislelizumab-lung-cancer-sbla-accepted-in-chinaseekingalpha

Tislelizumab Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and we believe it could serve as a key element of our immuno-oncology combination platform. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

PulseSelect™ Pulsed Field Ablation (PFA) System

Medtronic Announces First Procedures in Pivotal Trial to Evaluate Novel Ablation Technology in Treating Atrial Fibrillation

Study Will Determine the Safety and Effectiveness of Pulsed Electrical Fields to Interrupt Irregular Heart Rhythms

DUBLIN, March 4, 2021 /PRNewswire/ -- Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect™ Pulsed Field Ablation (PFA) System, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation (AF). The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health by Nitesh Sood, M.D., Fall River, Massachusetts; the second procedure was performed by Arnoldas Giedrimas, M.D., also at Southcoast Health. The PULSED AF Trial is the first global, pre-market, multi-center clinical study with IDE approval aimed to establish the safety and efficacy of the PulseSelect System.

PulseSelect™ Pulsed Field Ablation (PFA) System

The PULSED AF trial is a prospective, non-randomized, multi-center clinical trial that will enroll up to 500 patients who will be treated with the PulseSelect System across as many as 50 sites in the U.S., Canada, Europe, and Australia. PULSED AF is designed to evaluate the safety and efficacy of the PulseSelect System for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be assessed at six and 12 months.

"For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation," said Rob Kowal, M.D., Ph.D., chief medical officer of Cardiac Ablation Solutions, which is reported as part of the Cardiac and Vascular Group at Medtronic. "Developed internally at Medtronic, the PulseSelect System has the potential to create a paradigm shift in how cardiac ablations are performed for patients suffering from atrial fibrillation."

Pre-clinical research on the PulseSelect technology has included extensive work to understand the physiology and mechanism of action for this novel energy source, resulting in its designation in 2018 as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for the treatment of drug refractory recurrent symptomatic atrial fibrillation. PulseSelect was designated with Innovative Device Status, also known as Green Channel, in November 2020 by the Center for Medical Device Evaluation (CMDE), the arm of the National Medical Products Administration (NMPA) that sets medical device regulations for China.

https://www.medtronic.com/us-en/healthcare-professionals/products/cardiac-rhythm/ablation-arrhythmias/indications-safety-warnings.html

https://www.medtronic.com/covidien/en-us/products/ablation-systems.html

Medtronic initiates pivotal trial for PulseSelect System in atrial fibrillation

Mar. 04, 2021 3:28 PM ET Medtronic plc (MDT) By: Dulan Lokuwithana, SA News Editor

Medtronic plc (MDT -2.8%) has announced the first procedures in the investigational device exemption (“IDE”) pivotal trial to evaluate the PulseSelect Pulsed Field Ablation System in atrial fibrillation.

https://seekingalpha.com/news/3669589-medtronic-initiates-pivotal-trial-for-pulseselect-system-in-atrial-fibrillation

https://seekingalpha.com/symbol/MDT

INDICATIONS, SAFETY, AND WARNINGS CARDIAC ABLATION PRODUCTS FOR NON-AF ARRHYTHMIAS

Tirzepatide

Tirzepatide achieved superior A1C and body weight reductions across all three doses compared to injectable semaglutide in adults with type 2 diabetes

March 4, 2021Download PDFTrial participants taking the highest dose of tirzepatide (15 mg) achieved an A1C reduction of 2.46 percent and weight loss of 12.4 kg (27.3 lb., 13.1 percent), double the weight reduction compared to those taking semaglutide 1 mg
At the lowest dose of tirzepatide (5 mg), participants achieved A1C and body weight reductions of 2.09 percent and 7.8 kg (17.2 lb., 8.5 percent), significantly greater than semaglutide

INDIANAPOLIS, March 4, 2021 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to injectable semaglutide 1 mg in adults with type 2 diabetes in Eli Lilly and Company's (NYSE: LLY) 40-week SURPASS-2 clinical trial. In topline results from the largest SURPASS trial to date, using the efficacy estimandi, the highest dose of tirzepatide (15 mg) reduced A1C by 2.46 percent and body weight by 12.4 kg (27.3 lb., 13.1 percent). The lowest dose of tirzepatide (5 mg) reduced A1C by 2.09 percent and body weight by 7.8 kg (17.2 lb., 8.5 percent) compared to semaglutide at 1.86 percent and 6.2 kg (13.7 lb., 6.7 percent).

About tirzepatide
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).

For the latest updates, visit http://www.lillydiabetes.com/

To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

View original content to download multimedia:http://www.prnewswire.com/news-releases/tirzepatide-achieved-superior-a1c-and-body-weight-reductions-across-all-three-doses-compared-to-injectable-semaglutide-in-adults-with-type-2-diabetes-301239948.html

SOURCE Eli Lilly and Company

Lilly's tirzepatide improves blood glucose and weight loss vs. semaglutide in diabetes

Mar. 04, 2021 7:28 AM ET

Eli Lilly and Company (LLY)

By: Mamta Mayani, SA News Editor

Eli Lilly (NYSE:LLY) announces findings from its SURPASS-2 clinical trial, comparing the efficacy and safety of its tirzepatide 5 mg, 10 mg and 15 mg to Novo Nordisk's semaglutide in adults with type 2 diabetes.

https://seekingalpha.com/news/3669286-lillys-tirzepatide-shows-superiority-over-semaglutide-in-diabetes

https://seekingalpha.com/symbol/LLY

https://www.lilly.com/disease-areas/diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by diabetes. We offer a wide range of therapies and a continued determination to provide real solutions—from medicines and technologies to support programs and more.

DUPIXENT® (DUPILUMAB)

March 4, 2021 at 12:59 AM EST Back

FDA ACCEPTS DUPIXENT® (DUPILUMAB) FOR REVIEW IN CHILDREN WITH MODERATE-TO-SEVERE ASTHMA

TARRYTOWN, N.Y. and PARIS, March 4, 2021 /PRNewswire/ --

Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial

Dupixent has the potential to be a best-in-class treatment option in this younger population of children aged 6 to 11

Acceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the European Union (EU) regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021.

DUPIXENT® (DUPILUMAB)

About Dupixent
Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled.

Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including those in the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. Across all approved indications globally, more than 200,000 patients have been treated with Dupixent.

Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver.

U.S. INDICATIONS

DUPIXENT is a prescription medicine used:

to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

https://www.dupixent.com/

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-review-in-children-with-moderate-to-severe-asthma-301240295.html

SOURCE Regeneron Pharmaceuticals, Inc.

FDA accepts Regeneron, Sanofi's Dupixent application for children with asthma

Mar. 04, 2021 1:32 AM ET

Regeneron Pharmaceuticals, Inc. (REGN)

By: Mamta Mayani, SA News Editor

The FDA has accepted for review Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NASDAQ:SNY) supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.

https://seekingalpha.com/news/3669188-fda-accepts-regenerons-dupixent-application-for-children-with-asthma

https://seekingalpha.com/symbol/SNY

https://seekingalpha.com/symbol/REGN

https://www.dupixent.com/

Indications DUPIXENT is a prescription medicine used: to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

LORBRENA® (lorlatinib)

U.S. FDA EXPANDS APPROVAL OF PFIZER’S LORBRENA® AS FIRST-LINE TREATMENT FOR ALK-POSITIVE METASTATIC LUNG CANCER

Wednesday, March 03, 2021 - 07:03pm

Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI®

NEW YORK--(BUSINESS WIRE)-- The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program.

LORBRENA® (lorlatinib)

LORBRENA is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive NSCLC. Up to 40% of people with ALK-positive metastatic NSCLC present with brain metastases at initial diagnosis.1,2,3

The expanded approval of LORBRENA is based on the results from the pivotal Phase 3 CROWN trial, which showed a 72% reduction in risk of progression or death vs. XALKORI® (crizotinib) in a previously untreated patient population (HR 0.28: 95% CI, 0.19 to 0.41; p<0.0001) as assessed by blinded independent central review (BICR). Central nervous system (CNS) involvement was assessed in all patients. There were 17 patients in the LORBRENA arm and 13 in the XALKORI arm with measurable brain metastases based on baseline brain imaging. A prespecified exploratory analysis showed that among these patients, the intracranial objective response rate (IC-ORR), as assessed by BICR, was 82% (95% CI, 57 to 96) in the LORBRENA arm and 23% (95% CI, 5 to 54) in the XALKORI arm. The intracranial duration of response (IC-DOR) was 12 months or longer in 79% (n=11) and 0% of patients in the LORBRENA and XALKORI arms, respectively.

The most common adverse events (AEs) of any Grade and Grade 3-4 worsening laboratory abnormalities occurring in ≥20% of people treated with LORBRENA were edema (56%), weight gain (38%), peripheral neuropathy (35%), cognitive effects (21%), diarrhea (21%), dyspnea (20%), and hypertriglyceridemia (22%). Serious AEs occurred in 34% of people treated with LORBRENA; the most frequently reported serious AEs were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%). Fatal AEs occurred in 3.4% of people treated with LORBRENA and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%). Permanent discontinuation of LORBRENA due to AEs occurred in 6.7% of people. AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively. Detailed results from the CROWN study were published in the November 2020 issue of the New England Journal of Medicine.

About LORBRENA® (lorlatinib)

LORBRENA is a tyrosine kinase inhibitor (TKI) that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK. LORBRENA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.

LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

IMPORTANT LORBRENA® (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.

The full prescribing information for LORBRENA can be found here.

https://www.lorbrena.com/

In addition, to learn more, please visit us on www.Pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210303006042/en/

FDA OKs expanded use of Pfizer’s Lorbrena as first-line treatment in lung cancer

Mar. 04, 2021 12:59 AM ET

Pfizer Inc. (PFE)

By: Mamta Mayani, SA News Editor6 Comments

The FDA has approved Pfizer's (NYSE:PFE) supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

https://seekingalpha.com/news/3669183-fda-oks-expanded-use-of-pfizers-lorbrena-as-first-line-treatment-in-lung-cancer

https://seekingalpha.com/symbol/PFE

Indication LORBRENA is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of the body, and who have taken the medicine: alectinib, or ceritinib, or both crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and that is no longer responding to these treatments. It is not known if LORBRENA is safe and effective in children. The effectiveness of LORBRENA is based on a study that measured tumor response rate and duration of response. There is an ongoing study to find out how LORBRENA works over a longer period of time.

Dovato and Triumeq label expansion

ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside pipeline advances at CROI 2021

Data presented will demonstrate the potential of new antiretroviral mechanisms of action and long-acting medicines that challenge the HIV treatment and prevention paradigm

London, 2 March 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March.

What is TRIUMEQ? (abacavir, dolutegravir, lamivudine)

TRIUMEQ is a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used to treat HIV-1 infection in adults and in children who weigh at least 88 pounds. HIV-1 is the virus that causes AIDS. TRIUMEQ is not for use by itself in people who have or have had resistance to abacavir, dolutegravir, or lamivudine. It is not known if TRIUMEQ is safe and effective in children who weigh less than 88 pounds.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Medication Guide for TRIUMEQ and discuss it with your healthcare provider.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks of the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

Please click here for full Prescribing Information, including Boxed Warning and Medication Guide for TRIUMEQ.

https://us.triumeq.com/index/

Dovato(dolutegravir & lamivudine)

INDICATION

DOVATO is a complete prescription regimen to treat HIV-1 in adults who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their doctor determines they meet certain requirements.

Please read the Patient Information for DOVATO and discuss it with your healthcare provider.

https://www.dovato.com/

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

ViiV Healthcare wins FDA nod for Dovato and Triumeq label expansion

Mar. 02, 2021 1:51 PM ET GlaxoSmithKline plc (GSK ) By: Dulan Lokuwithana, SA News Editor

The FDA has approved the supplemental New Drug Applications for Dovato and Triumeq according to information available on the FDA website.

https://seekingalpha.com/news/3668425-viiv-healthcare-wins-fda-nod-for-dovato-and-triumeq-label-expansion

https://seekingalpha.com/symbol/GSK

https://seekingalpha.com/symbol/PFE

What is TRIUMEQ? TRIUMEQ is a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used to treat HIV-1 infection in adults and in children who weigh at least 88 pounds. HIV-1 is the virus that causes AIDS. TRIUMEQ is not for use by itself in people who have or have had resistance to abacavir, dolutegravir, or lamivudine. It is not known if TRIUMEQ is safe and effective in children who weigh less than 88 pounds. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please read the Medication Guide for TRIUMEQ and discuss it with your healthcare provider. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks of the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products. Please click here for full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.

AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII)

KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD

March 2, 2021 at 11:31 PM EST

Conference Call and Live Audio Webcast Scheduled for Tomorrow, Wednesday, March 3, at 8:30 a.m. ET

CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS™ (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII)

About AZSTARYSTM:

AZSTARYSTM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here: http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315.

For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com

KemPharm (KMPH) shares skyrocket 120% on FDA approval of ADHD drug

Mar. 03, 2021 5:56 AM ET KemPharm, Inc. (KMPH)

By: Mamta Mayani, SA News Editor15 Comments

KemPharm (NASDAQ:KMPH) soars 120% premarket after the FDA approved New Drug Application (NDA) for Azstarys (formerly referred to as KP415) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older.

https://seekingalpha.com/news/3668599-kempharm-shares-skyrocket-120-on-fda-approval-of-adhd-drug

https://seekingalpha.com/symbol/KMPH

AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII) is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of serdexmethylphenidate, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH. The complete approved prescribing information for AZSTARYS is provided below: Full Prescribing Information

FreeStyle Libre system

Abbott Receives Health Canada Authorization Under Interim Order to Expand Use of FreeStyle® Libre System for Pregnant Women in the Hospital and Professional Health Care Settings

More content below

Wed, March 3, 2021, 9:00 AM

Expanded use of FreeStyle Libre system allows health care workers in hospital and professional health care settings to remotely monitor expectant mothers' glucose status to minimize exposure to COVID-19
FreeStyle Libre is the only glucose sensing technology in Canada to replace the need for traditional finger pricks for people with and without diabetes, including pregnant women, in the healthcare setting

MISSISSAUGA, ON, March 3, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that Health Canada, under interim order, authorized the expanded use of the FreeStyle Libre flash glucose monitoring system in hospital and professional health care settings to include Canadian women who are pregnant.

Health Canada OKs expanded use of Abbott's FreeStyle Libre system

Mar. 03, 2021 11:03 AM ET Abbott Laboratories (ABT)

By: Jonathan M Block, SA News Editor

Health Canada has authorized the expanded use of Abbott Laboratories' (NYSE:ABT) FreeStyle Libre flash glucose monitoring system to include pregnant women in hospital or professional health care settings.

https://seekingalpha.com/news/3668802-health-canada-oks-expanded-use-of-abbott-freestyle-libre-system

https://www.abbott.com/

https://seekingalpha.com/symbol/ABT

Easy access to accurate, affordable testing:
That’s the benefit of being part of the FreeStyle family.

Get a Free Meter and automatic, more affordable5 co-pay6 for test strips per prescription.

https://www.myfreestyle.com/

What can continuous glucose monitoring (CGM) do for you?

https://www.freestyle.abbott/us-en/home.html

What can continuous glucose monitoring (CGM) do for you?

Vosoritide for Achondroplasia

BioMarin Completes Full Enrollment in Phase 2 Study of Vosoritide for Treatment of Infants and Young Children with AchondroplasiaTopline data expected to be available in mid-2022Mar 3, 2021

SAN RAFAEL, Calif., March 3, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ:BMRN

Description of Phase 2 Study in Infants and Young Children Ages 0 to 5 Years

This is a Phase 2 randomized, placebo-controlled study of vosoritide. The 52-week study consists of approximately 70 infants and young children with achondroplasia, aged zero to less than five years old (60 months). The study will be followed by a subsequent open-label extension trial when all subjects receive active treatment. Children in this study will have completed a three-to-six-month baseline study to determine their respective baseline growth prior to entering the Phase 2 study. The primary objectives of the study are to evaluate safety, tolerability, and the effect of vosoritide on height. The company also plans to augment the height data with other analyses of effects on growth and assessments including proportionality, functionality, quality of life, sleep apnea, and foramen magnum dimension, as well as the advent of major illnesses and surgeries.

https://www.biomarin.com/our-treatments/pipeline/vosoritide-for-achondroplasia/

For additional information, please visit www.biomarin.com.

Vosoritide for Achondroplasia

Vosoritide is an investigational analog of C-type Natriuretic Peptide (CNP) under evaluation for the treatment of children with achondroplasia, the most common form of skeletal dysplasia.

BioMarin completes enrollment in phase 2 study of vosoritide for achondroplasia

Mar. 03, 2021 10:06 AM ET

BioMarin Pharmaceutical Inc. (BMRN)

By: Jonathan M Block, SA News Editor

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) has completed enrollment in its phase 2 study examining vosoritide, a once-daily injection for children with achondroplasia, the most common form of disproportionate short stature in humans.

https://seekingalpha.com/news/3668760-biomarin-completes-enrollment-in-phase-2-study-of-vosoritide-for-achondroplasia

https://seekingalpha.com/symbol/BMRN

Vosoritide is an investigational analog of C-type Natriuretic Peptide (CNP) under evaluation for the treatment of children with achondroplasia, the most common form of skeletal dysplasia.

biotecMAX™ January/ February/March 2021 Insight

single-dose COVID-19 vaccine

Prognosis

U.S. Clears J&J’s Vaccine; U.K. Business Grants: Virus Update

Bloomberg News February 27, 2021, 6:08 PM EST Updated on February 28, 2021, 6:07 AM EST

Johnson & Johnson Covid-19 Vaccine Cleared for Use in U.S.

Riley Griffin

Feb 27, 2021

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use

Feb 26, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

Johnson & Johnson COVID-19 vaccine wins FDA's emergency-use approval

Feb. 27, 2021 6:21 PM ET Johnson & Johnson (JNJ) By: Jason Aycock, SA News Editor63 Comments

The Food and Drug Administration has granted emergency use authorization for Johnson & Johnson's (NYSE:JNJ) COVID-19 vaccine, the third such vaccine to be approved under EUA.

https://seekingalpha.com/news/3667403-johnson-johnson-covid-19-vaccine-wins-fdas-emergency-use-approval

F.D.A. Clears Johnson & Johnson’s Shot, Giving Americans a 3rd Vaccine

The approval of the vaccine, the first to require a single shot, will bring millions more doses to the U.S. within days.

See how the Johnson & Johnson vaccine works.

Amid Slow Vaccine Deliveries, Desperate E.U. Nations Hunt for More

FDA authorizes Johnson & Johnson’s single-shot coronavirus vaccine

The action by the Food and Drug Administration means the United States will have three vaccines a year after the virus began spreading rapidly. A few million doses of the newest shot are expected to be shipped shortly. By Laurie McGinley and Carolyn Y. Johnson

Merck to help make Johnson & Johnson's vaccine - Washington Post

Author of the article: Reuters Publishing date: Mar 02, 2021 • 52 minutes ago

Article content

Merck & Co Inc will help make rival Johnson & Johnson’s single-shot COVID-19 vaccine, the Washington Post reported on Tuesday, citing senior officials from U.S. President Joe Biden’s administration.

https://financialpost.com/pmn/business-pmn/merck-to-help-make-johnson-johnsons-vaccine-washington-post?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

https://seekingalpha.com/symbol/JNJ How effective is the Johnson & Johnson vaccine? Here's what to know March 4, 2021, 3:30 PM ESTBy Erika Edwards and Denise Chow

The first 4 million doses of Johnson & Johnson's Covid-19 vaccine are rolling out this week, joining vaccines from the drugmakers Moderna and Pfizer-BioNTech, which have been in use since December.

Johnson & Johnson's single-dose shot, made in partnership with Janssen Pharmaceuticals, differs from the two others in several ways. It's made differently, and, at first glance, it might appear to be less effective.

Full coverage of the coronavirus outbreak

But that doesn't necessarily mean the Johnson & Johnson vaccine is inferior. Here's why:https://www.nbcnews.com/news/amp/ncna1259652

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use First Single-Shot Vaccine in Fight Against Global Pandemic Data demonstrated protection against COVID-19 related hospitalization and death, across countries with different variants Available on not-for-profit basis for emergency pandemic use Shipping vaccine immediately, delivering more than 20 million doses to U.S. in March, 100 million doses in first half of 2021 NEW BRUNSWICK, N.J., February 27, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

FDA authorizes Johnson & Johnson COVID-19 vaccine

•Feb 27, 2021 ABC News

#Johnsons #COVID19 #CoronaVaccineUS

US approves Johnson & Johnson's COVID-19 vaccine for emergency use

•Feb 28, 2021 WION

Toripalimab

Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China

Sun February 28, 2021 8:15 PM|GlobeNewswire

-- Junshi grants AstraZeneca exclusive promotion rights of toripalimab in mainland China for the urothelial carcinoma indications and for all indications in non-core areas
-- Junshi will continue to be responsible for the promotion of other indications in core areas
--The companies will continue to explore business collaborations in overseas markets including emerging markets

SHANGHAI, China, March 01, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the Company has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. (“AstraZeneca Pharmaceutical” or the “Promoter”), pursuant to which Junshi Biosciences will grant AstraZeneca Pharmaceutical the exclusive promotion right of toripalimab in mainland China for the urothelial carcinoma indications to be approved subsequently for marketing and the exclusive promotion right for all indications approved and to be approved in non-core areas. Junshi Biosciences will continue to be responsible for the promotion of other indications approved and to be approved excluding urothelial carcinoma indications in core areas.

Toripalimab
About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On 17 December 2018, Toripalimab obtained a conditional approval from the the National Medical Products Administration (“NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designations from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (“FDA”) for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA application of Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

For more information, please visit: http://junshipharma.com.

THERAPEUTIC AREAS

https://junshipharma.com/en/Treatment.html

AstraZeneca, Junshi Bio collaborate to commercialize toripalimab in China

Feb. 28, 2021 11:36 PM ET AstraZeneca PLC (AZN) By: Mamta Mayani, SA News Editor 2 Comments

Junshi Biosciences grants AstraZeneca (NASDAQ:AZN) exclusive promotion rights of toripalimab in mainland China for the urothelial carcinoma indications and for all indications in non-core areas.

https://seekingalpha.com/news/3667416-astrazeneca-junshi-bio-ink-toripalimab-deal-in-china

https://seekingalpha.com/symbol/AZN

治疗领域解决未被满足的临床需求，实现病有所医

Health Canada authorizes AstraZeneca and Verity Pharmaceuticals Inc./Serum Institute of India COVID-19 vaccines

Fri February 26, 2021 10:16 AM|Canada Newswire

OTTAWA, ON, Feb. 26, 2021 /CNW/ - Today, Health Canada authorized two vaccines; the COVID-19 vaccine manufactured by AstraZeneca, and developed in partnership with Oxford University, and, the Serum Institute of India's version of the AstraZeneca vaccine.

These are the first viral vector-based COVID-19 vaccines authorized in Canada. The vaccines are authorized for use in people over 18 years of age. They are administered as a two-dose regimen and can be kept at refrigerated temperatures (from 2˚ to 8˚C) for at least six months, facilitating distribution across the country.

These vaccines were authorized with terms and conditions under Health Canada's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. This process allowed Health Canada to assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada's high standards.

Health Canada authorizes AstraZeneca COVID-19 vaccine

Feb. 26, 2021 10:52 AM ETAstraZeneca PLC (AZN)By: Jonathan M Block, SA News Editor13 Comments

Health Canada has authorized AstraZeneca's (NASDAQ:AZN) COVID-19 vaccine as well as the Serum Institute of India's version of the AstraZeneca vaccine. https://seekingalpha.com/news/3667222-health-canada-authorizes-astrazeneca-covid-19-vaccine

15 February, 2021

World Health Organisation (WHO) grants Emergency Use Listing (EUL) for the AstraZeneca/Oxford COVID-19 vaccine manufactured by Serum Institute of India

World Health Organisation (WHO) grants Emergency Use Listing (EUL) to the AstraZeneca/Oxford COVID-19 vaccine 'COVISHIELD' ChAdOx1-S [recombinant] manufactured by Serum Institute of India (SII). AstraZeneca and SII will now work with the COVAX initiative, enabling equitable global access to its COVID-19 vaccines.Read more...

Viral vector-based vaccines for COVID-19

About COVID-19 viral vector-based vaccines

Many vaccines are being studied to see if they will prevent COVID-19, and Health Canada is expediting reviews of all COVID-19 vaccine submissions.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/type-viral-vector.html

https://www.seruminstitute.com/product_covishield.php

https://www.seruminstitute.com/product_pipeline.php

https://seekingalpha.com/symbol/AZN

PRODUCTS SUPPLIED OVERSEAS | PRODUCTS SUPPLIED IN INDIA | PRODUCT LIST | PRODUCT PIPELINE PRODUCTS SUPPLIED OVERSEAS

Emgality® (galcanezumab)

Emgality® (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache

Thu February 25, 2021 9:00 AM|Canada Newswire|About: LLY

The first and only anti-CGRP treatment with dual indications

TORONTO, Feb. 25, 2021 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines. i

Emgality® (galcanezumab)

About Emgalityx
Emgality is a humanized IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) and prevents its biological activity. Emgality targets CGRP with high affinity (KD = 31 pM) and does not bind to the CGRP receptor or related peptides adrenomedullin, amylin, calcitonin and intermedin.

Emgality is administered subcutaneously through a single-use prefilled syringe or a prefilled pen and is intended for patient self-administration.

For the prevention of migraine, Emgality is available in pre-filled syringes and prefilled pens.xi
For episodic cluster headache, Emgality is available in 100 mg/mL prefilled syringes.

The recommended dose of Emgality for episodic cluster headache is 300 mg once a month (administered as three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Treatment benefit should be assessed within 3 weeks of the initiation of treatment. In patients with no improvement within this time, any further decisions for continuation of the treatment should be carefully considered based on individual patient basis and clinical judgement.x

https://www.emgality.com/

For full prescribing information, including Patient Information, please refer to the Canadian Product Monograph for Emgality, available at www.lilly.ca.

Emgality (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache

Published: Feb 25, 2021

https://www.biospace.com/article/releases/emgality-and-174-galcanezumab-now-approved-for-use-in-canada-for-the-treatment-of-episodic-cluster-headache/

https://seekingalpha.com/symbol/LLY

Important Facts About Emgality® (em-GAL-it-ē) injection. Also known as galcanezumab-gnlm. Emgality is a prescription medicine used in adults for: The preventive treatment of migraine. The medicine (120 mg) comes in a prefilled pen or syringe and is taken once a month. The treatment of episodic cluster headache. The medicine (300 mg) comes in three (100 mg) prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.

NVX‑CoV2373 (TAK-019)

Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan

Feb 26, 2021 at 8:22 AM ESTDownload PDF

Agreement includes COVID-19 vaccine technology transfer to Takeda for local manufacturing and commercialization in Japan
Takeda doses first participant in immunogenicity and safety study to support local regulatory application

GAITHERSBURG, Md., February 25, 2021 -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its collaboration with Takeda Pharmaceutical Company Limited, originally announced in August. The companies have signed an exclusive license agreement for Takeda’s development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. Additionally, Takeda dosed the first participants in a Phase 1/2 clinical trial to test the immunogenicity and safety of Novavax’ vaccine candidate in the Japanese population.

NVX‑CoV2373 (TAK-019)

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated 50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

For more information, visit www.novavax.com

https://seekingalpha.com/symbol/NVAX

Novavax, Takeda finalize licensing agreement for COVID-19 vaccine in Japan

Feb. 26, 2021 8:47 AM ETNovavax, Inc. (NVAX)By: Jonathan M Block, SA News Editor

Novavax Inc. (NASDAQ:NVAX) and Takeda Pharmaceutical Company Ltd. (NYSE:TAK) have finalized a license agreement that allows for Takeda’s development, manufacturing, and commercialization of Novavax’ COVID-19 vaccine candidate in Japan.

https://seekingalpha.com/news/3667122-novavax-takeda-finalize-licensing-agreement-for-covid-19-vaccine-in-japan

Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico Feb 22, 2021 at 7:00 AM EST Download PDF PREVENT-19 enrolls 30,000 volunteers across 118 sites in the U.S. and Mexico GAITHERSBURG, Md., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of the company’s COVID-19 vaccine. Novavax has previously reported positive interim efficacy results of NVX-CoV2373, its recombinant protein-based vaccine candidate, in an ongoing Phase 3 clinical trial taking place in the United Kingdom.

Roxadustat

Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease

PUBLISHED1 March 2021

1 March 2021 21:01 GMT

AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. Roxadustat is under regulatory review for the treatment of anaemia of chronic kidney disease (CKD).

AstraZeneca and FibroGen are committed to working with the FDA ahead of the meeting and to bringing roxadustat to patients with anaemia of CKD. A date for the advisory committee meeting has not been determined.

Roxadustat
Roxadustat, an oral medicine, is the first in a new class of treatments called HIF-PH inhibitors that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilisation, and reduction of hepcidin. Roxadustat is also in clinical development for anaemia associated with MDS and for chemotherapy-induced anaemia.

Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anaemia in CKD in NDD and DD adult patients. In Europe, the Marketing Authorisation Application for Evrenzo for the treatment of anaemia in CKD in NDD and DD patients was submitted by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020.

AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other countries in the Americas, Australia and New Zealand, as well as Southeast Asia. Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.

Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

FDA to hold AdCom meet to review FibroGen, AstraZeneca's kidney drug

Mar. 02, 2021 3:18 AM ET

FibroGen, Inc. (FGEN) By: Mamta Mayani, SA News Editor

The FDA will hold an advisory committee (AdCom) meeting to review FibroGen (NASDAQ:FGEN) and its partner, AstraZeneca's (NASDAQ:AZN) new drug application for roxadustat in U.S.

https://seekingalpha.com/news/3668096-fda-to-hold-adcom-meet-to-review-fibrogen-astrazenecas-kidney-drug

https://www.fibrogen.com/

https://seekingalpha.com/symbol/FGEN

https://www.astrazeneca.com/

https://seekingalpha.com/symbol/AZN

We are advancing roxadustat, our first-in-class, oral small molecule product candidate for the treatment of anemia associated with chronic kidney disease (CKD), through global Phase 3 clinical development.

https://www.fibrogen.com/roxadustat/

Roxadustat We are advancing roxadustat, our first-in-class, oral small molecule product candidate for the treatment of anemia associated with chronic kidney disease (CKD), through global Phase 3 clinical development.

Retifanlimab (formerly INCMGA0012)

Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)

February 26, 2021 DownloadPDF Format (opens in new window)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

About POD1UM-202

POD1UM-202 (NCT03597295) is a global, open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

Retifanlimab (formerly INCMGA0012)

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell anal carcinoma (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer, and the Biologics License Application for retifanlimab has been accepted for Priority Review.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

For additional information on Incyte, please visit Incyte.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210226005125/en/

Incyte's retifanlimab application validated in Europe for anal cancer

Feb. 26, 2021 4:39 AM ET Incyte Corporation (INCY)

By: Mamta Mayani, SA News Editor

The EMA has validated Incyte's (NASDAQ:INCY) Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who are intolerant of, platinum-based chemotherapy.

https://seekingalpha.com/news/3666998-incytes-retifanlimab-application-validated-in-europe

https://seekingalpha.com/symbol/INCY

At Incyte, our research is grounded in the relentless pursuit of scientific excellence and the conviction that the advancement of basic science can drive the discovery of innovative medicines for patients. Our world-class researchers are focused on transforming the treatment of cancer and inflammatory and autoimmune conditions, and are advancing a diversified portfolio of clinical candidates.

EPIDIOLEX®/EPIDYOLEX® (cannabidiol)

GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated with Tuberous Sclerosis Complex

February 26, 2021PDF Version

– If approved by the European Commission (EC), the label for EPIDYOLEX® will expand to include a third indication in Europe –

LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the Group”), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company’s Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC), for patients two years of age and older.

EPIDYOLEX® (cannabidiol)

EPIDIOLEX is the first and only FDA‑approved prescription cannabidiol (CBD).

It is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

https://www.epidiolex.com/

About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)
EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Commission (EC) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., EPIDIOLEX® is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or Tuberous Sclerosis Complex (TSC) in patients one year of age and older. EPIDIOLEX® has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome in patients two years and older. In September 2020, EPIDYOLEX® was approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. EPIDYOLEX® has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of seizures associated TSC.

https://www.gwpharm.com/

GW Pharma gets European nod on expanded label for Epidyolex

Feb. 26, 2021 11:09 AM ET GW Pharmaceuticals plc (GWPH)

By: Dulan Lokuwithana, SA News Editor

GW Pharmaceuticals (NASDAQ:GWPH) announced that the European Medicines Agency has issued a positive opinion on its Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex.

https://seekingalpha.com/news/3667230-gw-pharma-get-european-nod-on-expanded-label-for-epidyolex

https://seekingalpha.com/symbol/GWPH

EPIDIOLEX is the first and only FDA‑approved prescription cannabidiol (CBD). It is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

ORLADEYO™ (berotralstat)

BioCryst Receives Positive CHMP Opinion for ORLADEYO™ (berotralstat), an Oral, Once-daily Therapy to Prevent Attacks in Patients with Hereditary Angioedema

PDF Version

For investors and media only

RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of ORLADEYO™ (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

The European Commission (EC) will review the CHMP recommendation and a final approval decision from the EC on the marketing authorization application (MAA) for ORLADEYO is expected in the second quarter.

If approved, ORLADEYO would be the first oral, once-daily therapy in the European Union to treat patients with HAE by preventing recurrent attacks. The CHMP positive opinion is based on data from the pivotal APeX-2 clinical trial and supporting data from the APeX-S trial. In APeX-2, ORLADEYO met its primary endpoint (p<0.001) for ORLADEYO 150 mg compared to placebo. ORLADEYO showed a positive safety profile and was generally well-tolerated over 48 weeks in both APeX-2 and APeX-S.

ORLADEYO™ (berotralstat)

About ORLADEYO™ (berotralstat)

ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO™ (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

https://orladeyo.com/

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

For more information, please visit the company’s website at www.biocryst.com.

ORLADEYO™ (berotralstat)

ORLADEYO™ (berotralstat) is an oral, once-daily capsule that prevents hereditary angioedema (HAE) attacks by inhibiting plasma kallikrein. ORLADEYO is approved in the U.S. and Japan for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years of age and older. It is not known if ORLADEYO is safe and effective to treat an acute HAE attack, therefore ORLADEYO should not be used to treat an acute HAE attack. For additional information, please visit www.ORLADEYO.com, and for full U.S. prescribing information, click here.

The company also has a regulatory application under review with the European Medicines Agency (EMA).

https://www.biocryst.com/orladeyo/

BioCryst's ORLADEYO nabs CHMP positive recommendation in hereditary angioedema

Feb. 25, 2021 4:26 PM ET

BioCryst Pharmaceuticals, Inc. (BCRX)

By: Aakash Babu, SA News Editor6 Comments

BioCryst Pharmaceuticals (NASDAQ:BCRX) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of ORLADEYO (berotralstat) for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

https://seekingalpha.com/news/3666754-biocrysts-orladeyo-nabs-chmp-positive-recommendation-in-hereditary-angioedema

https://seekingalpha.com/symbol/BCRX

WHAT IS ORLADEYO™ (berotralstat)? ORLADEYO (or-luh-DAY-oh) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in adults and children 12 years of age and older. It is not known if ORLADEYO is safe and effective in children under 12 years of age. It is not known if ORLADEYO is safe and effective to treat an acute HAE attack, therefore ORLADEYO should not be used to treat an acute HAE attack. Do not take more than one capsule of ORLADEYO per day because extra doses can cause heart rhythm problems.

HUMIRA® (adalimumab)

February 24, 2021

HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

- HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis[1]
- Approval based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52[1,2]
- HUMIRA is now approved in the U.S. for use in 11 indications, including 5 approvals in pediatric populations

NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA induced clinical remission at Week 8 and maintained remission at Week 52 in patients who responded at Week 8.1,2

HUMIRA® (adalimumab)

More information on this trial can be found at www.clinicaltrials.gov (NCT02065557).

About HUMIRA (adalimumab) in the U.S.

Uses
HUMIRA is a prescription medicine used:

To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older.
To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Please click here for the Full Prescribing Information and Medication Guide.

https://www.humira.com/

For more information about AbbVie, please visit us at www.abbvie.com

AbbVie's HUMIRA wins FDA approval for ulcerative colitis

Feb. 25, 2021 7:39 AM ETAbbVie Inc. (ABBV)By: Aakash Babu, SA News Editor21 Comments

AbbVie (NYSE:ABBV) announces that the U.S. FDA has approved HUMIRA (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.

https://seekingalpha.com/news/3666307-abbvies-humira-wins-fda-approval-for-ulcerative-colitis

https://seekingalpha.com/symbol/ABBV

Uses HUMIRA is a prescription medicine used: To reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines. Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Ankylosing spondylitis (AS) in adults. Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab. Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough. Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older. In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines. To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) (UV) in adults and children 2 years of age and older.

biotecMAX™ January & February 2021 Insight

Single-Shot Janssen COVID-19 Vaccine Candidate

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.

Regulatory Filings The Company filed for Emergency Use Authorization (EUA) in the United States on February 4, 2021 and submitted a Conditional Marketing Authorisation Application (cMAA) in the European Union on February 15, 2021. In addition, rolling submissions for the investigational single-dose COVID-19 vaccine have been initiated in several countries worldwide. The Company will continue to provide data on an ongoing basis in support of WHO prequalification for the Janssen COVID-19 vaccine candidate.

Phase 3 ENSEMBLE Study Design The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years old and older. The trial, conducted in eight countries across three continents, includes a diverse and broad population. The study was designed to evaluate the safety and efficacy of the Janssen investigational vaccine in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The Company announced topline efficacy and safety data from ENSEMBLE on January 29, 2021. For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

Learn more at www.jnj.com. Follow us at @JNJNews.

FDA staff finds J&J COVID vaccine effective ahead of review

Feb. 24, 2021 8:44 AM ET Johnson & Johnson (JNJ) By: Dulan Lokuwithana, SA News Editor16 Comments

The FDA has released the briefing document for the COVID-19 vaccine candidate from Johnson & Johnson (NYSE:JNJ) ahead of its review scheduled for later this week.

https://seekingalpha.com/news/3665494-jnj-covid-19-vaccine-fda-releases-briefing-documents-ahead-of-review

HEALTH AND SCIENCE

FDA staff endorses J&J’s single-shot Covid vaccine for emergency use — clearing way for third vaccine in U.S.

PUBLISHED WED, FEB 24 20218:03 AM ESTUPDATED WED, FEB 24 202110:05 AM EST Berkeley Lovelace Jr.

KEY POINTS

The FDA’s staff endorsed Johnson & Johnson’s Covid-19 vaccine for emergency use, a critical step in bringing a third shot to the U.S. marketplace.
The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which will meet Friday to review J&J’s request for emergency use.

https://www.cnbc.com/2021/02/24/covid-vaccine-fda-staff-endorses-jjs-single-shot-for-emergency-use.html

FDA review confirms safety, efficacy of single-shot Johnson & Johnson coronavirus vaccine, especially against severe cases

By Carolyn Y. Johnson and Laurie McGinley Feb. 24, 2021 at 5:30 p.m. EST

https://www.washingtonpost.com/health/2021/02/24/johnson-and-johnson-vaccine/

Feb 26, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

Johnson & Johnson rises as COVID-19 vaccine clears FDA panel vote

Feb. 26, 2021 5:10 PM ET Johnson & Johnson (JNJ) By: Jason Aycock, SA News Editor106 Comments

Johnson & Johnson (NYSE:JNJ) has risen 1.9% postmarket after its COVID-19 vaccine has won approval from an FDA advisory panel for emergency use authorization.

https://seekingalpha.com/news/3667371-johnson-johnson-rises-as-covid-19-vaccine-clears-fda-panel-vote

https://seekingalpha.com/symbol/JNJ

Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational SingleShot Janssen COVID-19 Vaccine Candidate NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID19 vaccine candidate. The submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.

Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

•Feb 24, 2021 CBS News

Feb 26, 2021

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

One-shot coronavirus vaccine by Johnson & Johnson is safe and effective, US FDA finds

•Feb 24, 2021 South China Morning Post

Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib)

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

02/26/2021CATEGORY:

Corporate/Financial News

Recommendation based on the Phase 3 CheckMate -9ER trial, in which Opdivo in combination with Cabometyx doubled progression-free survival and significantly improved overall survival and response rates

Opdivo in combination with Cabometyx showed consistent efficacy benefits across key subgroups of patients

Opdivo in combination with Cabometyx also demonstrated a manageable safety profile, with a low rate of treatment-related discontinuations

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib)

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national Phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1≥1%) were randomized to receive Opdivo plus Cabometyx (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Inc., Ipsen and Takeda Pharmaceutical Company Limited.

About Opdivo®

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

https://www.opdivo.com/

CABOMETYX + OPDIVO results showed that:

People were able to live 2x LONGER without their tumor growing or spreading
People who took CABOMETYX + OPDIVO were able to live without their tumor progressing for a median† of 16.6 months compared to 8.3 months for people who took sunitinib.
†Median is the middle value in a set of the measurements—for some it was shorter; for others, longer.

TWICE AS MANY PEOPLE had meaningful reductions‡ in their tumor size
55.7% of people who took CABOMETYX + OPDIVO had reductions in tumor size, compared to 27.1% of people taking sunitinib.
Nearly TWICE AS MANY PEOPLE saw their tumors disappear completely (complete response)
CABOMETYX + OPDIVO
8% complete response
48% partial response

https://www.cabometyx.com/cabometyx-opdivo

For more information about Bristol Myers Squibb, visit us at BMS.com

Bristol Myers' opdivo combo wins positive opinion from EU in kidney cancer

Feb. 26, 2021 6:59 AM ET

Bristol-Myers Squibb Company (BMY)

By: Mamta Mayani, SA News Editor4 Comments

The European Medicines Agency's advisory group CHMP has recommended approval of Bristol Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) in combination with Exelixis’ (NASDAQ:EXEL) Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma.

https://seekingalpha.com/news/3667040-ema-backs-bristol-myers-opdivo--cabometyx-in-kidney-cancer

https://seekingalpha.com/symbol/EXEL

https://seekingalpha.com/symbol/BMY

What is CABOMETYX? CABOMETYX is a prescription medicine used to treat: People with kidney cancer (renal cell carcinoma). CABOMETYX may be used: Alone to treat people with renal cell carcinoma (RCC) that has spread (advanced RCC) In combination with nivolumab when your cancer has spread (advanced RCC), and you have not already had treatment for your advanced RCC People with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib. It is not known if CABOMETYX is safe and effective in children.

CABENUVA (rilpivirine and cabotegravir)

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months If approved, expanded use would offer adults living with HIV an every-two-months longacting injectable option for maintaining viral suppression TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

CABENUVA (rilpivirine and cabotegravir)

About ATLAS-2M (NCT03299049) The ATLAS-2M study is an ongoing Phase 3b, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two-months, 3 mL dose of each medicine) compared to every four weeks (once-monthly, 2 mL dose of each medicine) over a 48-week treatment period in 1,045 adults living with HIV-1.2 Participants were required to be virologically suppressed for six months or greater, on first or second antiretroviral regimen, with no prior virologic failure. The primary outcome measure for the study is the proportion of participants with HIV-1 RNA ≥50 c/mL at Week 48 using the FDA Snapshot algorithm (ITT-E population). For further information please see https://clinicaltrials.gov/ct2/show/NCT03299049. About CABENUVA (rilpivirine and cabotegravir) CABENUVA is approved as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA is administered by a healthcare provider as two intramuscular injections (cabotegravir, rilpivirine) in the buttocks.

The complete regimen combines rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, with the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Please see full Prescribing Information.

Learn more at www.janssen.com and follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Biopharma, Inc. and Janssen Sciences Ireland UC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.

https://seekingalpha.com/symbol/JNJ

You've heard about it. Now ask about it. CABENUVA IS NOW APPROVED

Tislelizumab (BGB-A317

Novartis strengthens Oncology pipeline with successful closing of tislelizumab in-licensing

Back to News Archive

Feb 26, 2021

Adds tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody for monotherapy and proprietary combination cancer therapies with Novartis portfolio and pipeline therapies
Novartis will co-develop tislelizumab with BeiGene and expand access to patients in North America, Europe and Japan
Specifically designed to minimize binding to FcγR on macrophages, tislelizumab will be key asset in Novartis immuno-oncology combination strategy

Basel, February 26, 2021 — Novartis today announced that it has closed the in-licensing of tislelizumab from BeiGene, Ltd. in North America, Europe and Japan. Tislelizumab is a uniquely designed anti-PD-1 antibody, specifically engineered to minimize binding to FcyR on macrophages, that is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.

Novartis has identified multiple opportunities to combine tislelizumab with other therapies in the Novartis portfolio and pipeline. Tislelizumab is currently being studied in non-small cell lung cancer, gastric cancer, hepatocellular carcinoma and nasopharyngeal carcinoma, with broad potential in several other solid tumors.

Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologic program, and we believe it could serve as a key element of our immuno-oncology combination platform. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab

Find out more at https://www.novartis.com.

BeiGene closes tislelizumab collaboration and license agreement with Novartis

Feb. 26, 2021 7:34 AM ET BeiGene, Ltd. (BGNE) By: Aakash Babu, SA News Editor

BeiGene (NASDAQ:BGNE) announces the closing of the collaboration and license agreement with Novartis Pharma AG to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab.

https://seekingalpha.com/news/3667072-beigene-closes-tislelizumab-collaboration-and-license-agreement-with-novartis

https://www.beigene.com/

https://seekingalpha.com/symbol/BGNE

https://www.novartis.com/

https://seekingalpha.com/symbol/NVS

BeiGene Announces Closing of Collaboration with Novartis to Develop and Commercialize Anti-PD-1 Antibody Tislelizumab in North America, Europe and Japan February 26, 2021 at 7:00 AM EST CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--Feb. 26, 2021-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced the closing of the collaboration and license agreement with Novartis Pharma AG, previously announced on January 11, 2021, to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. The companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.

COVID-19 BOOSTER AND NEW VACCINE VARIANTS

NEWS/ Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

PFIZER AND BIONTECH INITIATE A STUDY AS PART OF BROAD DEVELOPMENT PLAN TO EVALUATE COVID-19 BOOSTER AND NEW VACCINE VARIANTS

Thursday, February 25, 2021 - 06:45am

The evaluation is part of the Phase 1/2/3 trial and will study a third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1 participants to evaluate the safety and tolerability of a booster vaccine
Discussions with regulatory authorities are ongoing regarding an additional registration-enabling study using an mRNA vaccine with a variant sequence; this would provide a flexible solution for rapidly adapting the vaccine for use against the B.1.351 lineage or other new strains that may emerge as possible immune escape virus variants
Based on in-vitro studies conducted to date and observations from real world evidence, the Companies have not observed changes to neutralizing antibody levels that would predict a significant reduction in protection provided by two doses of BNT162b2

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the United States who will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen. The study is part of the Companies’ clinical development strategy to determine the effectiveness of a third dose against evolving variants.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005515/en/

For more information, please visit www.BioNTech.de.

In addition, to learn more, please visit us on www.Pfizer.com

AUTHORIZED USE IN THE U.S.:

The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.

Pfizer Details Plans for Studying Booster Shots Against Variants

Pfizer and Biontech start study to evaluate COVID-19 booster and new vaccine variants

Feb. 25, 2021 7:03 AM ET Pfizer Inc. (PFE) By: Aakash Babu, SA News Editor2 Comments

Pfizer (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have begun an evaluation of the safety and immunogenicity of a third dose of their COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against the virus caused by the circulating and potential newly emerging SARS-CoV-2 variants.

https://seekingalpha.com/news/3666230-pfizer-and-biontech-start-study-to-evaluate-covid-19-booster-and-new-vaccine-variants

https://seekingalpha.com/symbol/PFE

https://seekingalpha.com/symbol/BNTX

BioNTech, Pfizer could have capacity for 3 billion COVID-19 vaccines in 2022 - Bloomberg

Mar. 09, 2021 5:13 PM ETBioNTech SE (BNTX)By: Jonathan M Block, SA News Editor7 Comments

BioNTech (NASDAQ:BNTX) CEO Ugur Sahin says that the company along with partner Pfizer (NYSE:PFE) may have the capacity to deliver 3 billion doses of its COVID-19 in 2022.
Sahin told Bloomberg in an interview that BioNTech and Pfizer already have an order book of 1.3 billion doses and are discussing the potential for hundreds of millions of doses more as options with government organizations.

https://seekingalpha.com/news/3670969-biontech-pfizer-could-have-capacity-for-3-billion-covid-19-vaccines-in-2022-bloomberg

BioNTech, Pfizer could have capacity for 3 billion COVID-19 vaccines in 2022
https://www.bloomberg.com/news/articles/2021-03-09/biontech-pfizer-could-have-capacity-for-3-billion-doses-in-2022 BioNTech Sees Higher Dose Capacity; Brazil Deaths: Virus Update

Global Information About Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)

PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

EUROPEAN MEDICINES AGENCY ACCEPTS PFIZER’S MARKETING AUTHORIZATION APPLICATION FOR ITS INVESTIGATIONAL 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FOR ADULTS 18 YEARS OF AGE OR OLDER

Friday, February 26, 2021 - 06:45am

If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins.

PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

ABOUT 20vPnC

Pfizer’s 20vPnC vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes in Prevenar 13®1 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD),iii,iv,v,vi,vii and have been associated with high case-fatality rates,viii,ix,x,xi antibiotic resistance,5,xii,xiii and/or meningitis.xiv,xv Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease globally.xvi,xvii,xviii,xix,xx,xxi,xxii

The U.S. FDA has accepted for priority review the biologics license application of 20vPnC in adults 18 years of age and older with a Prescription Drug User Fee Act goal date in June 2021. In June 2020 Pfizer announced initiation of two Phase three trials for 20vPnC evaluating the safety and efficacy of the investigational vaccine in infants.

INDICATIONS FOR PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

Prevnar 13® is a vaccine approved for adults 18 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
Prevnar 13® is also approved for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 strains of Streptococcus pneumoniae in the vaccine, and for children 6 weeks through 5 years (prior to the 6th birthday) for the prevention of ear infections caused by 7 of the 13 strains in the vaccine
Prevnar 13® is not 100% effective and will only help protect against the 13 strains in the vaccine

In addition, to learn more, please visit us on www.Pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210226005036/en/

https://seekingalpha.com/symbol/PFE

https://www.pfizer.com/science/drug-product-pipeline

PRODUCT PIPELINE FOR NEW PHARMACEUTICAL DRUGS OUR MEDICINES IN DEVELOPMENT Our priority is researching and developing medicines and vaccines that will benefit patients around the world. We are committed to addressing unmet needs across a number of important therapeutic areas including, Oncology, Inflammation & Immunology, Vaccines, Internal Medicine and Rare Disease, with the goal of delivering innovative products to patients.

GENOTROPIN® (somatropin)

EMA ACCEPTS MARKETING APPLICATION FOR SOMATROGON TO TREAT PEDIATRIC PATIENTS WITH GROWTH HORMONE DEFICIENCY

Friday, February 26, 2021 - 06:30am

– If approved, somatrogon will serve as a once-weekly treatment option –

NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/

GENOTROPIN® (somatropin)

https://www.genotropin.com/

INDICATIONS

GENOTROPIN is a prescription product for the treatment of growth failure in children:

Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD)
With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor
Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA)
With a genetic condition called Turner syndrome (TS)
With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause

GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content or services of this site.

About GENOTROPIN® (somatropin)

GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

About Somatrogon

Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of growth hormone deficiency.

For more information, visit http://www.OPKO.com.

In addition, to learn more, please visit us on www.pfizer.com

Pfizer, OPKO Health's somatrogon application validated in Europe

Feb. 26, 2021 8:38 AM ETPfizer Inc. (PFE)By: Mamta Mayani, SA News Editor5 Comments

The European Medicines Agency has validated for review Pfizer (NYSE:PFE) and OPKO Health's (NASDAQ:OPK) marketing authorization application (MAA) for somatrogon, a long-acting recombinant human growth hormone for the treatment of pediatric patients with growth hormone deficiency (GHD).

https://seekingalpha.com/news/3667118-pfizer-opko-healths-somatrogon-application-validated-in-europe

https://www.opko.com/

https://seekingalpha.com/symbol/OPK

https://seekingalpha.com/symbol/PFE

https://www.genotropin.com/

INDICATIONS GENOTROPIN is a prescription product for the treatment of growth failure in children: Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD) With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA) With a genetic condition called Turner syndrome (TS) With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088. This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content or services of this site.

REGEN-COV (casirivimab with imdevimab)

February 26, 2021 at 6:46 AM EST Back

EMA ISSUES ADVICE ON REGENERON'S ANTIBODY COCKTAIL (CASIRIVIMAB WITH IMDEVIMAB) FOR CERTAIN COVID-19 PATIENTS

TARRYTOWN, N.Y., Feb. 26, 2021 /PRNewswire/ --

EU member states can utilize the positive CHMP opinion when making national decisions about use of the antibody cocktail, prior to a potential future EMA market authorization

Regeneron has collaborated with Roche to develop and manufacture the antibody cocktail; Roche is responsible ex-U.S. and has already begun distribution in the EU

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's investigational COVID-19 antibody cocktail (casirivimab with imdevimab). The CHMP recommends that the antibody cocktail, known as REGEN-COVTM in the U.S., can be used to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

REGEN-COV (casirivimab with imdevimab)

About the Antibody Cocktail

The antibody cocktail, known as REGEN-COV (casirivimab with imdevimab) in the U.S., consists of two monoclonal antibodies (also known as REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

In November 2020, REGEN-COV received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

REGEN-COV continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalized and certain hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of February 2021, approximately 23,000 people have participated in clinical trials involving REGEN-COV. Lower doses of REGEN-COV are also being studied with the aim of increasing the number of patients who could potentially be treated if the cocktail is approved.

REGEN-COV was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune® and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn).

Authorized Emergency Use

REGEN-COV (casirivimab with imdevimab) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. REGEN-COV is not FDA approved for any use and its safety and effectiveness has not yet been established for the treatment of COVID-19.

This authorized use is only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564 (b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Limitations of Authorized Use

-- REGEN-COV is not authorized for use in patients:

who are hospitalized due to COVID-19, OR
who require oxygen therapy due to COVID-19, OR
who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

-- Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/ema-issues-advice-on-regenerons-antibody-cocktail-casirivimab-with-imdevimab-for-certain-covid-19-patients-301236407.html

SOURCE Regeneron Pharmaceuticals, Inc.

Regeneron's antibody cocktail is set for marketing approval in EU

Feb. 26, 2021 9:21 AM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Dulan Lokuwithana, SA News Editor1 Comment

The European Medicines Agency has issued a positive opinion for the investigational COVID-19 antibody cocktail (casirivimab with imdevimab) developed by Regeneron (NASDAQ:REGN).

https://seekingalpha.com/news/3667153-regenerons-antibody-cocktail-is-set-for-marketing-approval-in-eu

https://seekingalpha.com/symbol/REGN

REGEN-COV™ (casirivimab with imdevimab) Emergency Use Authorization (EUA) REGEN-COV (casirivimab with imdevimab to be administered together) has been granted an Emergency Use Authorization by the US FDA.

Tezepelumab

Tezepelumab is the first biologic to consistently and significantly reduce exacerbations in broad population of severe asthma patients

PUBLISHED26 February 2021

26 February 2021 14:00 GMT

Tezepelumab demonstrated superiority versus placebo across every primary and key secondary endpoint in NAVIGATOR Phase III trial

Positive full results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab demonstrated a statistically significant and clinically meaningful1 reduction in the annualised asthma exacerbation rate (AAER) in severe, uncontrolled asthma patients.2 The results were presented at the American Academy of Asthma Allergy & Immunology Virtual Annual Meeting.2

Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC.2 SoC was medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).2

Tezepelumab

Tezepelumab is the only biologic medicine to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of baseline eosinophil count across Phase II and Phase III clinical trials.2-9

In a pre-planned subgroup analysis, tezepelumab achieved a statistically significant and clinically meaningful 41% reduction (p<0.001) in AAER in patients with baseline eosinophil counts less than 300 cells per microlitre.2 Importantly, clinically meaningful reductions in AAER were also observed in two additional subgroups: 39% in patients with baseline eosinophil counts less than 150 cells per microlitre and 70% in patients with greater than or equal to 300 cells per microlitre.2

Tezepelumab demonstrated statistically significant improvements in every key secondary endpoint compared to placebo, including lung function measurements, asthma control and health-related quality of life.2

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and headache.2

NAVIGATOR is a pivotal Phase III trial that will form the basis of regulatory submission.

Tezepelumab blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.3,10 NAVIGATOR is the first Phase III trial to show benefit in severe asthma by targeting TSLP.2

The statistically significant and clinically meaningful exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microlitre support the US Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.2,3 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

Tezepelumab
Tezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma.3,10 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.3,10 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,25 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.3,25 Tezepelumab acts at the top of the inflammation cascade and has the potential to treat a broad population of severe asthma patients regardless of their type of inflammation.3,25

AstraZeneca and Amgen collaboration
In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialise tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada. AstraZeneca’s share of gross profits from tezepelumab in the US will be recognised as collaboration revenue. In all countries outside the US and Canada, AstraZeneca will solely commercialise tezepelumab. AstraZeneca will record all sales outside of the US as product sales and recognise Amgen’s share of gross profit as cost of sales.

Please visit astrazeneca.com

AstraZeneca and Amgen's tezepelumab successful in phase 3 for severe asthma

Feb. 26, 2021 10:27 AM ET

AstraZeneca PLC (AZN)By: Jonathan M Block, SA News Editor1 Comment

AstraZeneca (NASDAQ:AZN) and Amgen (NASDAQ:AMGN) have released full phase 3 results of the biologic tezepelumab in severe asthma patients demonstrating a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER). https://seekingalpha.com/news/3667206-astrazeneca-and-amgens-tezepelumab-successful-in-phase-3-for-severe-asthma

https://seekingalpha.com/symbol/AZN

https://www.amgen.com/

https://seekingalpha.com/symbol/AMGN

Tezepelumab Is The First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma Data From Investigational Therapy Tezepelumab Phase 3 NAVIGATOR Trial in Patients With Severe Asthma Presented at the American Academy of Asthma Allergy & Immunology Annual Meeting THOUSAND OAKS, Calif., Feb. 26, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. When added to standard of care (SoC), tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma, compared to placebo.1 The results were presented at the American Academy of Asthma Allergy & Immunology Annual Meeting. NAVIGATOR is a pivotal Phase 3 trial that will form the basis of regulatory filing.

CABOMETYX® (cabozantinib)

Exelixis Announces Breakthrough Therapy Designation Granted to Cabozantinib for the Treatment of Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid CancerPDF Version

– U.S. FDA designation based on an interim analysis of the phase 3 COSMIC-311 pivotal trial, in which cabozantinib demonstrated significant improvement in progression-free survival –

– Exelixis expects to submit supplementary New Drug Application in 2021 –

ALAMEDA, Calif.--(BUSINESS WIRE)--Feb. 25, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib (CABOMETYX®) as a potential treatment for patients with differentiated thyroid cancer (DTC) that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The FDA’s Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement on at least one clinically significant endpoint over existing therapies.

CABOMETYX® (cabozantinib)

https://www.cabometyx.com/

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX is not indicated for radioiodine-refractory differentiated thyroid cancer.

More information about this trial is available at ClinicalTrials.gov.

Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

For more information about Exelixis, please visit www.exelixis.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005336/en/

Exelixis' CABOMETYX wins FDA's breakthrough therapy status

Feb. 25, 2021 8:36 AM ET Exelixis, Inc. (EXEL) By: Aakash Babu, SA News Editor

Exelixis (NASDAQ:EXEL) announces that the U.S. FDA has granted Breakthrough Therapy Designation to cabozantinib (CABOMETYX) as a potential treatment for certain patients with differentiated thyroid cancer (DTC).

https://seekingalpha.com/news/3666384-exelixis-cabometyx-wins-fdas-breakthrough-therapy-status

https://seekingalpha.com/symbol/EXEL

https://www.cabometyx.com/

biotecMAX™ January & February 2021 Insight

Pfizer-BioNTech COVID19 Vaccine

Pfizer Expands Production, Adds Suppliers for Covid-19 Doses

By Riley Griffin February 19, 2021, 3:56 PM EST Updated on February 19, 2021, 4:35 PM EST

Pfizer will 'more than double' COVID-19 vaccine output in U.S., CEO Bourla says

Feb. 19, 2021 4:25 PM ET Pfizer Inc. (PFE) By: Jonathan M Block, SA News Editor78 Comments

Speaking after President Joe Biden toured a Pfizer (NYSE:PFE) manufacturing plant in Michigan, company CEO Albert Bourla said that the pharma anticipates it will "more than double" the 5 million doses of COVID-19 vaccine it is producing each week in the U.S. in the next few weeks, according to Reuters.

https://seekingalpha.com/news/3664106-pfizer-will-more-than-double-covid-19-vaccine-output-in-us-ceo-bourla-says

Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women

PDF Version

Phase 2/3 trial will enroll approximately 4,000 healthy pregnant women in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, U.K., and Spain
First participants dosed in the U.S.
Women enrolled in the trial will be unblinded shortly after giving birth to allow those women who originally received placebo to be vaccinated while staying in the study

New York, USA and Mainz, Germany, February 18, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older.

https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-commence-global-clinical-trial-evaluate

PFIZER AND BIONTECH SUBMIT COVID-19 VACCINE STABILITY DATA AT STANDARD FREEZER TEMPERATURE TO THE U.S. FDA

Friday, February 19, 2021 - 07:00amEST

NEW YORK and MAINZ, GERMANY, February 19, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data

Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show

In a win for global vaccination goals, BioNTech-Pfizer vaccine is shown to generate strong response with one dose and to maintain potency in standard freezers for two weeks

By Jared S. Hopkins and Bojan Pancevski Updated Feb. 19, 2021 6:18 pm ET

https://www.wsj.com/articles/single-dose-of-pfizer-vaccine-is-85-effective-israeli-study-shows-11613723218?mod=hp_lead_pos2&source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

AFTER AUTHORIZATION, ISRAEL PLANS TO VACCINATE KIDS UNDER 16

Vaccine prevents 98.9% of COVID deaths, Israel’s Health Ministry data shows

Officials hail ‘dramatically’ effective Pfizer shots; two weeks after second dose, vaccine also 99.2% protective against serious illness, reduces chance of hospitalization by 98.9%

By TOI STAFF 20 February 2021, 8:33 pm

https://www.timesofisrael.com/israel-says-vaccine-dramatically-effective-prevents-98-9-of-covid-deaths/?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

02.19.2021
Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

02.18.2021
Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women

https://www.pfizer.com/

https://seekingalpha.com/symbol/PFE

https://biontech.de/

https://seekingalpha.com/symbol/BNTX

Welcome to BioNTechs’s COVID-19 information portal

TicoVac™ (TBE vaccine, whole virus inactivated)

U.S. FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC™ (TICK-BORNE ENCEPHALITIS VACCINE)

Tuesday, February 23, 2021 - 04:30pm

Tick-borne encephalitis (TBE) is a viral infection, endemic to parts of Europe and Asia

If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac™, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older.1,2 If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas. In line with Priority Review designation, the FDA will target an action within six months of the application submission date,3 with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021.

About TicoVac™ (TBE vaccine, whole virus inactivated)

Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun™ in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature.13 Therefore, it is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.14 The vaccine helps provide protection against all known subtypes of the TBE virus in both children (from one year of age) and adults,1,2,14 including the European, Siberian and Far Eastern subtypes.15,16

More than 40 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 160 million doses of the vaccine have been distributed since 1976.7,17

About TBE

TBE is a viral infection of the brain and spine,4 transmitted to humans through the bite of an infected tick,5 and less frequently by ingestion of unpasteurized milk or milk products from infected animals.4 It may initially be mistaken for summer flu,18,19 but can be a serious condition with possible long-term consequences.4,19 More than 1 in 3 people can have long-term effects that last months or yearsincluding cognitive changes, muscle weakness or permanent paralysis,4,19 and in rare cases (0.5-2%; up to 20% in Russia), people may die.20,21 TBE can affect people of all ages who come into contact with ticks whenever they do outdoor activities in countries where ticks infected with TBE are prevalent.4,21

Although TBE is not endemic in the U.S., TBE has been reported in more than 35 countries, ranging from Western Europe to Japan.5 Currently there is no cure or treatment for TBE, only management of symptoms.4 The potential vaccine could help protect people from the U.S. who are traveling to or living in endemic regions.

to learn more, please visit us on www.Pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210223006109/en/

FDA grants priority review status for Pfizer's TicoVac marketing application

Feb. 23, 2021 4:46 PM ET

Pfizer Inc. (PFE) By: Aakash Babu, SA News Editor6 Comments

Pfizer (NYSE:PFE) announces that the U.S. FDA has granted a priority review status to the company’s Biologics License Application (BLA) for TicoVac, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older.

https://seekingalpha.com/news/3665204-fda-grants-priority-review-status-for-pfizers-ticovac-marketing-application

https://seekingalpha.com/symbol/PFE

PD-L1 IHC 22C3 pharmDx assay

Agilent PD-L1 IHC 22C3 pharmDx Receives Expanded FDA Approval in Non-small Cell Lung Cancer (NSCLC)

Companion diagnostic can help guide treatment decisions in cases of NSCLC

SANTA CLARA, Calif., February 22, 2021

Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo® (cemiplimab-rwlc). This announcement underscores Agilent's continuing commitment to the development of IHC-based diagnostics for cancer therapy.

PD-L1 IHC 22C3 pharmDx assay

https://www.agilent.com/en/product/pharmdx

"Anti-PD-1 therapies, including Libtayo, continue to broaden the potential for the treatment of patients across different cancer types,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "With the FDA approval of PD-L1 IHC 22C3 pharmDx as a companion diagnostic for treatment with Libtayo monotherapy in advanced NSCLC, Agilent further strengthens its ability to elevate pathologist confidence in reporting results to oncologists and bolsters our role as a global pioneer in developing companion diagnostics for targeted treatments."

Regeneron and Sanofi developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 clinical trial.3

Agilent’s pharmDx assay approved for use in non-small cell lung cancer

Feb. 22, 2021 3:08 PM ET

Agilent Technologies, Inc. (A)

By: Dulan Lokuwithana, SA News Editor

Agilent Technologies (A -2.4%) has announced the FDA approval for its PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (“NSCLC”).

https://seekingalpha.com/news/3664514-agilents-pharmdx-assay-approved-for-use-in-non-small-cell-lung-cancer

https://www.agilent.com/

https://seekingalpha.com/symbol/A

Our pharmDx Solution is a portfolio of all-in-one pharmDx kits that lead to optimal diagnostic results within companion diagnostics. Correct results the first time help select the right therapy for each patient - every time. pharmDx is all about personalized medicine pharmDx kits make a difference to the assessment of patient treatment. The validated kits have the right specificity and sensitivity. Correct results the first time lead to fewer reruns and will help select the right therapy for each patient - every time. We help improve patient care by delivering fast results with great confidence and reducing time from biopsy to diagnosis.

Otezla® (apremilast)

Amgen Submits Supplemental New Drug Application for Otezla® (apremilast) for Adults with Mild-To-Moderate Plaque Psoriasis

Filing Based on Data From Phase 3 ADVANCE Study

THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.

Otezla® (apremilast)

About Otezla® (apremilast)
OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

https://www.otezla.com/

Please click here for Otezla® Full Prescribing Information.

For more information, visit www.amgen.com

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SOURCE Amgen

Amgen submits Otezla plaque psoriasis marketing application to the FDA

Feb. 22, 2021 10:53 AM ETAmgen Inc. (AMGN)By: Aakash Babu, SA News Editor

Amgen (AMGN +0.3%) announced the submission of a supplemental New Drug Application ((sNDA )) to the U.S. FDA for Otezla (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.

https://seekingalpha.com/news/3664353-amgen-submits-otezla-plaque-psoriasis-marketing-application-to-the-fda

https://seekingalpha.com/symbol/AMGN

APPROVED USES Otezla® (apremilast) is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis. Otezla is a prescription medicine approved for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

LIBTAYO® (CEMIPLIMAB-RWLC)

February 22, 2021 at 1:00 PM EST Back

FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) MONOTHERAPY FOR PATIENTS WITH FIRST-LINE ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%

TARRYTOWN, N.Y. and PARIS, Feb. 22, 2021 /PRNewswire/ --

Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials

This is the third approval for Libtayo in the U.S.

LIBTAYO® (CEMIPLIMAB-RWLC)

Across all of its approved indications, the recommended dose of Libtayo is 350 mg administered as an intravenous infusion over 30 minutes every three weeks, until disease progression or unacceptable toxicity. Libtayo is available as a single-dose 350 mg vial.

In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.

Libtayo was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically-humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune® and related VelociSuite® technologies. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Dupixent® (dupilumab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb), Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) and Regeneron's antibody cocktail for COVID-19, which was recently granted Emergency Use Authorization (EUA) in the U.S.

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

It is not known if Libtayo is safe and effective in children.

https://www.libtayo.com/

Please see accompanying full Prescribing Information, including Medication Guide.

For additional information about the company, please visit www.regeneron.com

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SOURCE Regeneron Pharmaceuticals, Inc.

Regeneron and Sanofi get FDA approval for Libtayo in non-small cell lung cancer

Feb. 22, 2021 1:24 PM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Dulan Lokuwithana, SA News Editor8 Comments

The FDA has approved LIBTAYO (cemiplimab-rwlc) as a first-line treatment for patients with locally advanced or metastatic Non-Small Cell Lung Cancer ("NSCLC"). Those with locally advanced tumors should not be candidates for surgical resection or definitive chemoradiation.

https://seekingalpha.com/news/3664445-regeneron-and-sanofi-get-fda-approval-for-libtayo-in-non-small-cell-lung-cancer

https://seekingalpha.com/symbol/REGN

https://seekingalpha.com/symbol/SNY

RINVOQ (upadacitinib)

February 22, 2021

Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients

- 33 percent of patients achieved the primary endpoint of clinical remission (per Adapted Mayo Score) compared to 4 percent of patients treated with placebo at week 8 (p<0.001)[1]
- All ranked secondary endpoints were met[1]
- These results reaffirm findings from the first Phase 3 induction study, U-ACHIEVE[1,2]
- Safety results were consistent with the previous Phase 3 induction study and the known profile of upadacitinib, with no new safety risks observed[1-6]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe ulcerative colitis and several other immune-mediated diseases[1,7-14]

NORTH CHICAGO, Ill., Feb. 22, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH.1 In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001).1 U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1

RINVOQ (upadacitinib)

About Upadacitinib (RINVOQ)

Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.1,7-14 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.3 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing.8-14 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

https://www.rinvoq.com/

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide.

For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

For more information about AbbVie, please visit us at www.abbvie.com.

AbbVie's upadacitinib successful in late-stage ulcerative colitis study

Feb. 22, 2021 9:17 AM ETAbbVie Inc. (ABBV)By: Mamta Mayani, SA News Editor4 Comments

AbbVie (NYSE:ABBV) announces that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH in adults with moderate to severe ulcerative colitis.

https://seekingalpha.com/news/3664317-abbvies-upadacitinib-successful-in-late-stage-ulcerative-colitis-study

https://seekingalpha.com/symbol/ABBV

https://www.rinvoq.com/

Sotorasib

FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

FDA Target Action Date is Aug. 16, 2021

THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.

Sotorasib

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, a KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest global clinical program exploring 10 combinations with clinical sites spanning five continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 700 patients studied across 13 tumor types.

For information, please visit www.codebreaktrials.com.

To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com.

For more information, visit www.amgen.com

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SOURCE Amgen

Amgen receives FDA priority review status for lung cancer therapy

Feb. 17, 2021 6:49 AM ET

Amgen Inc. (AMGN) By: Dulan Lokuwithana, SA News Editor

Amgen (NASDAQ:AMGN) has announced that the FDA has granted priority review for sotorasib, its KRAS inhibitor currently undergoing a global Phase 3 randomized active-controlled study (CodeBreaK 200) in patients with KRAS G12C-mutant non-small cell lung cancer ("NSCLC").

https://seekingalpha.com/news/3662708-amgen-receives-fda-priority-review-status-for-lung-cancer-therapy

https://seekingalpha.com/symbol/AMGN

A robust pipeline leveraging state-of-the-art science and molecular engineering focused on the pursuit of transformative medicines with large effects in serious diseases. Human genetic validation is used to strengthen the evidence base of as many of our programs as possible.

ORGOVYXTM (relugolix)

MYOVANT SCIENCES AND PFIZER ANNOUNCE PUBLICATION IN THE NEW ENGLAND JOURNAL OF MEDICINE OF PHASE 3 LIBERTY STUDIES OF ONCE-DAILY RELUGOLIX COMBINATION THERAPY IN WOMEN WITH UTERINE FIBROIDS

Wednesday, February 17, 2021 - 04:59pmEST

BASEL, Switzerland and NEW YORK, February 17, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced publication in the New England Journal of Medicine of the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks.

ORGOVYXTM (relugolix)

LIBERTY 1 and LIBERTY 2 each met the primary endpoint, with 73.4% and 71.2% of women in the relugolix combination therapy groups achieving the responder criteria compared with 18.9% and 14.7% of women in the placebo groups at Week 24, respectively (both p < 0.001). A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline in each study (both p < 0.001 compared to placebo).

“We are pleased that the New England Journal of Medicine recognized the importance of our Phase 3 LIBERTY program and published the study results, which support the potential of once-daily relugolix combination therapy in women with uterine fibroids,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “As we approach our FDA target action date of June 1, we look forward, if approved, to providing a one pill, once-a-day treatment for the millions of women with uterine fibroids who need and deserve new options.”

In LIBERTY 1 and LIBERTY 2, six of seven key secondary endpoints measured at Week 24 achieved statistical significance, including mean reduction in menstrual blood loss, amenorrhea, reduction in pain in women with pain at baseline, improvement on the Bleeding and Pelvic Discomfort scale, reduction in uterine volume (all p < 0.001 compared to placebo), and improvement in anemia in those women with anemia at baseline (both p < 0.05 compared to placebo). In addition, among the approximately 50% of women with moderate-to-severe pain at baseline, a significantly greater proportion of women receiving relugolix combination therapy reported minimal-to-no pain (maximum score of 1 on a 0 to 10 Numerical Rating Scale) during the last 35 days of treatment compared to placebo (43% vs. 10% and 47% vs. 17%, respectively; both p < 0.001). A seventh key secondary endpoint for reduction in fibroid volume was not achieved in either study.

Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2. The overall incidence of adverse events in the relugolix combination and placebo groups were also comparable (62% vs. 66% and 60% vs. 59%, respectively), including hot flashes (11% vs. 8% and 6% vs. 4%, respectively). There were no pregnancies reported in the relugolix combination groups in either study.

For more information, please visit our website at www.myovant.com.

In addition, to learn more, please visit us on www.Pfizer.com

https://www.orgovyx.com/

What is ORGOVYX?

ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer.

It is not known if ORGOVYX is safe or effective in females or children.

Please see full Prescribing Information and Patient Product Information for ORGOVYX.

Reference:

ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Myovant Sciences, Inc.; 2020.

Myovant, Pfizer's relugolix combo shows durable efficacy in uterine fibroids

Feb. 18, 2021 5:06 AM ET Myovant Sciences Ltd. (MYOV)

By: Mamta Mayani, SA News Editor6 Comments

Myovant Sciences (NYSE:MYOV) and Pfizer (NYSE:PFE) announces publication of Phase 3 LIBERTY 1 and LIBERTY 2 studies of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids in the New England Journal of Medicine.

https://seekingalpha.com/news/3663304-myovant-pfizers-relugolix-combo-shows-efficacy-in-uterine-fibroids

RELUGOLIX
COMBINATION
THERAPY

Relugolix combination therapy consists of relugolix 40 mg in combination with estradiol (1.0 mg) and a progestin (0.5 mg norethindrone acetate). Relugolix combination therapy is an oral investigational drug candidate for the treatment of uterine fibroids and endometriosis.

https://www.myovant.com/our-science/relugolix-combination-therapy/

https://seekingalpha.com/symbol/MYOV

https://seekingalpha.com/symbol/PFE

What is ORGOVYX? ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer. It is not known if ORGOVYX is safe or effective in females or children. Please see full Prescribing Information and Patient Product Information for ORGOVYX. Reference: ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Myovant Sciences, Inc.; 2020. x You are about to leave ORGOVYX.com Continue No thanks, I'd like to stay on ORGOVYX.com The website you are linking to is neither owned nor controlled by Myovant Sciences GmbH. Myovant Sciences GmbH is not responsible for the content or services on the site. Contact Us

Ruxolitinib Cream

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis

February 19, 2021 DownloadPDF Format (opens in new window)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

Ruxolitinib Cream

TRuE-AD results presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020 examined sleep quality, sleep depth and restoration associated with sleep, key quality of life measures for people with AD.

For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

For additional information on Incyte, please visit Incyte.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210219005026/en/

FDA accepts Incyte's ruxolitinib NDA with Priority Review

Feb. 19, 2021 9:26 AM ET

Incyte Corporation (INCY) By: Jonathan M Block, SA News Editor

The FDA has accepted with Priority Review Incyte's (NASDAQ:INCY) NDA for ruxolitinib cream for atopic dermatitis.
Ruxolitinib is a selective JAK1/JAK2 inhibitor.

https://seekingalpha.com/news/3663913-fda-grants-priority-review-for-ruxolitinib-nda

https://seekingalpha.com/symbol/INCY

DERMATOLOGY Over the last 18+ years, our science-first approach and heritage in immunology has formed the foundation of our company. We are committed to discovering and developing best-in-class medicines to bring innovative solutions to patients in need, including those with dermatologic conditions.

Tirzepatide

Tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes in two phase 3 trials from Lilly's SURPASS program

February 17, 2021 Download PDF In the 52-week SURPASS-3 study - the longest in the program to date - the highest dose of tirzepatide reduced A1C by 2.37 percent and body weight by 12.9 kg (28.4 lb., 13.9 percent)

INDIANAPOLIS, Feb. 17, 2021 /PRNewswire/ -- Tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes in Eli Lilly and Company's (NYSE: LLY) SURPASS-3 and SURPASS-5 phase 3 clinical trials after 52 weeks and 40 weeks, respectively. In topline results, the primary and all key secondary endpoints were met for both estimandsi in SURPASS-3, which compared tirzepatide to titrated insulin degludec, and in SURPASS-5, which compared tirzepatide to placebo, both as an add-on to titrated insulin glargine.

Tirzepatide

About Tirzepatide
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP has been shown to decrease food intake and increase energy expenditure therefore resulting in weight reductions, and when combined with a GLP-1 receptor agonist, may result in greater effects on glucose and body weight. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).

About SURPASS-3, SURPASS-5 and the SURPASS Clinical Trial Program
SURPASS-3 (NCT03882970) is a 52-week, multi-center, randomized, open-label trial evaluating the efficacy of tirzepatide 5 mg, 10 mg and 15 mg compared to titrated insulin degludec on glycemic control in adults with type 2 diabetes treated with metformin with or without an SGLT-2 inhibitor.

For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

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SOURCE Eli Lilly and Company

Lilly’s Tirzepatide studies achieve primary and secondary endpoints

Feb. 17, 2021 9:40 AM ET Eli Lilly and Company (LLY) By: Dulan Lokuwithana, SA News Editor1 Comment

Eli Lilly and Company (NYSE:LLY) announced that its GLP-1 receptor agonist Tirzepatide met primary and all key secondary endpoints in two phase 3 clinical trials that evaluated its efficacy in adults with type 2 diabetes.
The study SURPASS-3 compared tirzepatide to titrated insulin degludec while SURPASS-5 compared tirzepatide to placebo, both as an add-on to titrated insulin glargine.

https://seekingalpha.com/news/3662856-lillys-tirzepatide-studies-achieve-primary-and-secondary-endpoints

https://seekingalpha.com/symbol/LLY

Medicines in Development Molecule & Potential Indication Data as of January 26, 2021 Interested in Lilly clinical trials? Learn more at LillyTrialGuide.com

Dojolvi™ (UX007/triheptanoin)

Feb 17, 2021PDF Version

Ultragenyx Announces Approval of Dojolvi™ (UX007/triheptanoin) in Canada for the Treatment of Long-chain Fatty Acid Oxidation Disorders in Adults and Children

First Approved Treatment for Adult and Pediatric Patients with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) in Canada

NOVATO, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that Health Canada has approved Dojolvi™ (triheptanoin) as a source of calories and fatty acids for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD). Long-chain fatty acid oxidation disorders (LC-FAOD) are a group of rare, genetic, life-threatening disorders caused by defects in the enzymes needed to produce energy from fatty acids. Dojolvi is a highly purified, synthetic, 7-carbon fatty acid triglyceride specifically designed to provide medium-chain, odd-carbon fatty acids as an energy source and metabolite replacement for people with LC-FAOD.

Dojolvi™ (UX007/triheptanoin)

About Dojolvi™ (triheptanoin)
Dojolvi is a highly purified, pharmaceutical-grade, odd-carbon medium-chain triglyceride consisting of three 7-carbon fatty acids on a glycerol backbone created via a multi-step chemical process. It is designed to provide medium-chain, odd-carbon fatty acids as an energy source and metabolite replacement for people with LC-FAOD.

Dojolvi is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD).

For important safety information, please consult the Dojolvi Product Monograph at www.ultragenyx.com/canada/medicines/dojolvi-product-monograph-CANADA/

WHAT IS DOJOLVI?

DOJOLVI is a prescription medicine used to treat long-chain fatty acid oxidation disorders (LC-FAOD) in children and adults.

https://www.dojolvi.com/

For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.

Ultragenyx Dojolvi treatment wins Health Canada approval for rare genetic disorder

Feb. 17, 2021 9:08 AM ETUltragenyx Pharmaceutical Inc. (RARE)By: Aakash Babu, SA News Editor

Ultragenyx Pharmaceutical (NASDAQ:RARE) announces that Health Canada has approved Dojolvi (triheptanoin) as a source of calories and fatty acids for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD).

https://seekingalpha.com/news/3662826-ultragenyx-dojolvi-treatment-wins-health-canada-approval-for-rare-genetic-disorder

https://seekingalpha.com/symbol/RARE

WHAT IS DOJOLVI? DOJOLVI is a prescription medicine used to treat long-chain fatty acid oxidation disorders (LC-FAOD) in children and adults

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

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Feb 16, 2021

Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3
Expanded indication enables potential treatment of more adults with left ventricular ejection fraction (LVEF) below normal, the group where benefits are most clearly evident1
Of the more than 6 million Americans suffering from chronic heart failure (CHF), approximately 5 million may be appropriate for treatment with Entresto3,4

Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal1. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat1.

Entresto® (sacubitril/valsartan)

About Entresto
In Europe, Entresto is indicated in adult patients for the treatment of symptomatic chronic HF with reduced ejection fraction10. In the United States, Entresto is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal1. LVEF is a variable measure, so use clinical judgment in deciding whom to treat1. Approved indications may vary depending upon the individual country.

Entresto is a twice-a-day medicine that reduces the strain on the failing heart10. It does this by enhancing protective neurohormonal systems (i.e., natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS)10,11. Other common HF medicines, called angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan1,10.

https://www.entresto.com/index.jsp

This information is not comprehensive. Please see full Prescribing Information, including Boxed WARNING, and Patient Prescribing Information.

Find out more at https://www.novartis.com.

FDA expands heart failure indication for Novartis' Entresto

Feb. 16, 2021 1:52 PM ET Novartis AG (NVS) By: Jonathan M Block, SA News Editor

The FDA has approved an expanded indication for Novartis' (NYSE:NVS) Entresto to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure.

https://seekingalpha.com/news/3662423-fda-expands-novartis-entresto-heart-failure-indication

https://seekingalpha.com/symbol/NVS

INDICATION What is ENTRESTO? ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in adults with long-lasting (chronic) heart failure. ENTRESTO is usually used with other heart failure therapies, in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB) therapy.

biotecMAX™ January & February 2021 Insight

LIBTAYO® (CEMIPLIMAB)

February 12, 2021 at 1:00 AM EST Back

THE LANCET PUBLISHES LIBTAYO® (CEMIPLIMAB) DATA SHOWING EXTENDED OVERALL SURVIVAL IN PATIENTS WITH FIRST-LINE ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%

TARRYTOWN, N.Y. and PARIS, Feb. 12, 2021 /PRNewswire/ --

Libtayo was superior in extending overall survival compared to chemotherapy even with a high crossover rate

Data are the basis for multiple ongoing regulatory submissions, including in the U.S. and European Union

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced The Lancet published results from a pivotal trial designed to evaluate the investigational use of the PD-1 inhibitor Libtayo® (cemiplimab) compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression in tumor cells. The data were shared during a late-breaking presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress and formed the basis of regulatory submissions in the U.S. and European Union (EU). The U.S. Food and Drug Administration (FDA) granted a Priority Review with a target action date of February 28, 2021. A European Commission decision is expected by mid-2021.

LIBTAYO® (CEMIPLIMAB)

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC. Libtayo is also being investigated in pivotal trials in NSCLC (in combination with chemotherapy) and cervical cancer, as well as in trials combining Libtayo with either conventional or novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain types of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Please see accompanying full Prescribing Information, including Medication Guide.

https://www.libtayo.com/

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/the-lancet-publishes-libtayo-cemiplimab-data-showing-extended-overall-survival-in-patients-with-first-line-advanced-non-small-cell-lung-cancer-with-pd-l1-expression-of-50-301227396.html

SOURCE Regeneron Pharmaceuticals, Inc.

Regeneron/ Sanofi score an early win for Libtayo in basal cell carcinoma

Feb. 11, 2021 6:45 AM ET Regeneron Pharmaceuticals, Inc. (REGN)

By: Dulan Lokuwithana, SA News Editor6 Comments

Early this week, Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced the FDA approval for the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for patients with advanced basal cell carcinoma (“BCC”).

https://seekingalpha.com/news/3661076-regeneron-sanofi-score-an-early-win-for-libtayo-in-basal-cell-carcinoma

https://seekingalpha.com/symbol/REGN

https://seekingalpha.com/symbol/SNY

What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain types of skin cancer by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Vicineum™

Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum™

February 16, 2021 at 7:00 AM ESTPDF Version

FDA stated it is not currently planning to hold an advisory committee meeting

Potential for Vicineum to be a best-in-class treatment with projected peak revenue of $1B-$3B globally, $400M-$900M in the US

Company to hold conference call at 8am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 16, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

Vicineum™

About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

For more information, please visit the company’s website at www.sesenbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005637/en/

Sesen Bio nabs FDA priority review status for Vicineum marketing application

Feb. 16, 2021 8:34 AM ET Sesen Bio, Inc. (SESN) By: Aakash Babu, SA News Editor1 Comment

Sesen Bio (NASDAQ:SESN) shares jump nearly 19% premarket after it announces that the U.S. FDA has accepted the Biologics License Application for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted it a "Priority Review" status.

https://seekingalpha.com/news/3662166-sesen-bio-nabs-fda-priority-review-status-for-vicineum-marketing-application

For more information, please visit the company’s website at www.sesenbio.com.

https://seekingalpha.com/symbol/SESN

VICINEUM FOR BLADDER CANCER our initial focus for Vicineum is on treating bladder cancer. Vicineum is being evaluated in the Phase 3 VISTA trial

PADCEV® (enfortumab vedotin-ejfv)

Seagen and Astellas Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

02/12/2021

- Findings from the EV-301 Trial Showed Significant Improvements in Overall Survival and Progression-Free Survival Compared to Chemotherapy -

- EV-301 Intended to Support Global Registrations, Convert Accelerated to Regular Approval in U.S. -

- Data Published in the New England Journal of Medicine, Presented at the 2021 ASCO Genitourinary Cancers Symposium -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received PADCEV in the trial lived a median of 3.9 months longer than those who received chemotherapy. Median overall survival was 12.9 vs. 9.0 months, respectively (HR=0.70 [95 percent Confidence Interval (CI): 0.56-0.89], p=0.001). For patients in the PADCEV arm of the trial, maculopapular rash, fatigue and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events (TRAEs) occurring in more than 5 percent of patients.

PADCEV® (enfortumab vedotin-ejfv)

About the EV-301 Trial

About PADCEV® (enfortumab vedotin-ejfv)

PADCEV was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA’s Accelerated Approval Program based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.3

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.3,4 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).4 PADCEV is co-developed by Seagen and Astellas.

For more information, please see the full Prescribing Information for PADCEV here.

https://www.padcev.com/

For more information, please visit our website at https://www.astellas.com/en.

About the Seagen and Astellas Collaboration

Seagen and Astellas are co-developing enfortumab vedotin under a collaboration that was entered into in 2007 and expanded in 2009.

For more information on our marketed products and robust pipeline, visit www.seagen.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005069/en/

Seagen/Astella announce data showing survival advantage of PADCEV in bladder cancer

Feb. 12, 2021 3:15 PM ET Seagen Inc. (SGEN) By: Dulan Lokuwithana, SA News Editor10 Comments

Seagen Inc. (NASDAQ:SGEN) and Astellas Pharma (OTCPK:ALPMF) announced the interim results from the phase 3 EV-301 trial comparing PADCEV (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer.

https://seekingalpha.com/news/3661868-seagenastella-announce-data-showing-survival-advantage-of-padcev-in-bladder-cancer

https://seekingalpha.com/symbol/ALPMF

https://seekingalpha.com/symbol/SGEN

https://www.padcev.com/

View All News

Seagen and Astellas Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

02/12/2021

- Durable Tumor Responses Experienced Among Patients Previously Treated with Immunotherapy in Second Cohort of EV-201 Trial -

- Data Presented in Oral Presentation at the 2021 ASCO Genitourinary Cancers Symposium -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503

https://investor.seagen.com/press-releases/news-details/2021/Seagen-and-Astellas-Announce-Presentation-of-Results-from-PADCEV-enfortumab-vedotin-ejfv-Pivotal-Trial-in-Patients-with-Previously-Treated-Advanced-Urothelial-Cancer-Who-Were-Ineligible-for-Cisplatin-Chemotherapy/default.aspx

View All News

Seagen and Astellas Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

02/18/2021

- Submissions will be Reviewed Under Real-Time Oncology Review Based on Clinical Trials EV-301 and Cohort 2 of EV-201 -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV® (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV’s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201’s second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

https://investor.seagen.com/press-releases/news-details/2021/Seagen-and-Astellas-Announce-Submission-of-Two-Supplemental-Biologics-License-Applications-to-the-U.S.-FDA-for-PADCEV-enfortumab-vedotin-ejfv-in-Locally-Advanced-or-Metastatic-Urothelial-Cancer/default.aspx

TUKYSA® (tucatinib)

European Commission Approves Seagen’s TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

02/12/2021

- Approved for Adult Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Anti-HER2 Treatment Regimens -

- First HER-2 Tyrosine Kinase Inhibitor Combination Regimen to Improve Overall and Progression-Free Survival in Previously Treated Patients with Metastatic HER2-Positive Breast Cancer With or Without Brain Metastases -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) today announced that the European Commission (EC) has granted marketing authorization for TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

TUKYSA® (tucatinib)

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

https://www.tukysa.com/

For more information, please see the full Prescribing Information for TUKYSA here.

For more information on the company’s marketed products and robust pipeline, visit www.seagen.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005062/en/

Seagen’s Tukysa wins European approval for breast cancer

Feb. 12, 2021 7:45 AM ETSeagen Inc. (SGEN)By: Mamta Mayani, SA News Editor

The European Commission (EC) has granted marketing authorization for Seagen's (NASDAQ:SGEN) Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

https://seekingalpha.com/news/3661666-seagens-tukysa-wins-european-approval-for-breast-cancer

https://seekingalpha.com/symbol/SGEN

INDICATION: TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments. It is not known if TUKYSA is safe and effective in children.

Once-Weekly Semaglutide in Adults with Overweight or Obesity

List of authors.

John P.H. Wilding, D.M.,
Rachel L. Batterham, M.B., B.S., Ph.D.,
Salvatore Calanna, Ph.D.,
Melanie Davies, M.D.,
Luc F. Van Gaal, M.D., Ph.D.,
Ildiko Lingvay, M.D., M.P.H., M.S.C.S.,
Barbara M. McGowan, M.D., Ph.D.,
Julio Rosenstock, M.D.,
Marie T.D. Tran, M.D., Ph.D.,
Thomas A. Wadden, Ph.D.,
Sean Wharton, M.D., Pharm.D.,
Koutaro Yokote, M.D., Ph.D.,
et al.,
for the STEP 1 Study Group*

February 10, 2021
DOI: 10.1056/NEJMoa2032183

CONCLUSIONS

In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight. (Funded by Novo Nordisk; STEP 1 ClinicalTrials.gov number, NCT03548935. opens in new tab).

https://www.novonordisk.com/

Novo's semaglutide shows positive effect on obesity in late-stage study,

Feb. 11, 2021 1:31 PM ETNovo Nordisk A/S (NVO)By: Dulan Lokuwithana, SA News Editor8 Comments

Novo Nordisk (NVO +3.6%) has surged today after the New England Journal of Medicine published the results of its diabetic therapy semaglutide undergoing a Phase 3 trial to treat obesity.
Semaglutide is an analog that mimics the human glucagon-like peptide-1 (GLP-1) hormone which is released into the blood after a meal. It induces weight loss by reducing hunger.

https://seekingalpha.com/news/3661338-novo-nordisk-surges-after-phase-3-data-for-semaglutide-for-obesity-published-in-journal

https://seekingalpha.com/symbol/NVO

At Novo Nordisk, our R&D pipeline reflects our long-standing commitment to driving change to defeat diabetes and other serious chronic conditions.

Our scientists are currently working on novel and innovative treatments to address the unmet needs of people living with diabetes, obesity, haemophilia, growth disorders and non-alcoholic steatohepatitis (NASH).

https://www.novonordisk.com/science-and-technology/r-d-pipeline.html

At Novo Nordisk, our R&D pipeline reflects our long-standing commitment to driving change to defeat diabetes and other serious chronic conditions. Our scientists are currently working on novel and innovative treatments to address the unmet needs of people living with diabetes, obesity, haemophilia, growth disorders and non-alcoholic steatohepatitis (NASH).

investigational bispecific antibody, faricimab

New phase III data show Roche’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients

Across four studies in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD), approximately half of people receiving faricimab could be treated every four months in the first year
Approximately three-quarters of people receiving faricimab could be treated every three months or longer in the first year
Faricimab showed rapid and consistent improvements in anatomical outcomes including central subfield thickness across all studies
If approved, faricimab would be the first in a new class of medicine in 15 years for people with nAMD and in close to a decade in DME

Basel, 12 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY)

investigational bispecific antibody, faricimab

YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE).

About the TENAYA and LUCERNE studies7,8
TENAYA (NCT03823287) and LUCERNE (NCT03823300)

About faricimab
Faricimab is the first investigational bispecific antibody designed for the eye.4 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions.4 Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation.1 By simultaneously blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilise blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions.1

For more information, please visit www.roche.com.

https://seekingalpha.com/symbol/RHHBY

New Phase III Data Show Genentech’s Faricimab Is the First Investigational Injectable Eye Medicine to Extend Time Between Treatments up to Four Months in Two Leading Causes of Vision Loss, Potentially Reducing Treatment Burden for Patients Published: Feb 12, 2021 Logo Feb. 12, 2021 06:00 UTC Across four studies in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD), approximately half of people receiving faricimab could be treated every four months in the first year Approximately three-quarters of people receiving faricimab could be treated every three months or longer in the first year Faricimab showed rapid and consistent improvements in anatomical outcomes including central subfield thickness across all studies If approved, faricimab would be the first in a new class of medicine in 15 years for people with nAMD and in close to a decade in DME SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

EVKEEZA™ (EVINACUMAB-DGNB)

February 11, 2021 at 2:00 PM EST Back

FDA APPROVES FIRST-IN-CLASS EVKEEZA™ (EVINACUMAB-DGNB) FOR PATIENTS WITH ULTRA-RARE INHERITED FORM OF HIGH CHOLESTEROL

TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ --

Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C)

In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 weeks, compared to placebo

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first FDA-approved treatment that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism.

EVKEEZA™ (EVINACUMAB-DGNB)

About EvkeezaTM (evinacumab-dgnb)
Evkeeza is a fully-human monoclonal antibody that binds to and blocks the function of ANGPTL3. Regeneron scientists discovered the angiopoietin gene family more than two decades ago. Human genetics research published in NEJM in 2017 by scientists from the Regeneron Genetics Center found that patients whose ANGPTL3 gene did not function properly (called a "loss-of function mutation") have significantly lower levels of key blood lipids, including LDL-C, and this is associated with a significantly lower risk of coronary artery disease.

Evkeeza was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has also been used to create multiple antibodies including Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) and Regeneron's antibody cocktail for COVID-19, which was recently granted Emergency Use Authorization (EUA) in the U.S.

Regulatory review for Evkeeza is ongoing in the European Union. In June 2020, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended an accelerated assessment for Evkeeza based on the high unmet medical need and therapeutic innovation demonstrated by the product.

https://www.evkeeza.com/

INDICATION

EVKEEZA™ is an injectable prescription medicine used along with other low-density lipoprotein (LDL) lowering medicines in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol.
The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known.
It is not known if EVKEEZA is safe and effective in children with HoFH under 12 years of age.

EVKEEZA™
(evinacumab-dgnb) INJECTION

https://www.regeneron.com/evkeeza-injection

FDA approves Regeneron's Evkeeza to treat ultra-rare inherited form of high cholesterol

Feb. 11, 2021 2:13 PM ET Regeneron Pharmaceuticals, Inc. (REGN) By: Aakash Babu, SA News Editor11 Comments

The U.S. FDA has approved Regeneron Pharma's (REGN +0.3%) Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia ((HoFH)), an ultra-rare inherited condition that affects about 1,300 patients in the U.S.

https://seekingalpha.com/news/3661347-fda-approves-regenerons-evkeeza-to-treat-ultra-rare-inherited-form-of-high-cholesterol

https://seekingalpha.com/symbol/REGN

Regeneron capital expenditures surpass $600 million in race to add factory, lab space

By Robin K. Cooper – Reporter, Albany Business Review13 hours ago

Regeneron Pharmaceuticals spent nearly $615 million last year renovating and expanding New York laboratories and factories in East Greenbush and Limerick, Ireland.

https://www.bizjournals.com/albany/news/2021/02/16/regeneron-capex-surpasses-600-million.html

INDICATION EVKEEZA™ is an injectable prescription medicine used along with other low-density lipoprotein (LDL) lowering medicines in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol. The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known. It is not known if EVKEEZA is safe and effective in children with HoFH under 12 years of age.

REBLOZYL® (LUSPATERCEPT)

HEALTH CANADA APPROVES REBLOZYL® (LUSPATERCEPT), NEW CLASS OF TREATMENT FOR ADULT PATIENTS LIVING WITH MYELODYSPLASTIC SYNDROMES

FEBRUARY 16, 2021Download PDF

REBLOZYL®, an erythroid maturation agent, is the first and only of its kind approved for use in Canada

MONTREAL--(BUSINESS WIRE)-- Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept for injection) for the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC red blood cell (RBC) units over 8 weeks resulting from very low-to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy.1 REBLOZYL® represents a new class of treatment for eligible patients as the first and only approved erythroid maturation agent in Canada.1

REBLOZYL® (LUSPATERCEPT)

REBLOZYL® helps to regulate late-stage RBC maturation in order to potentially reduce the need for RBC transfusions.1

“Bristol Myers Squibb is thrilled to provide Canadians with an additional option beyond RBC transfusions to treat MDS-associated anemia,” said Al Reba, General Manager, Bristol Myers Squibb Canada. “This first-in-class treatment is an example of Bristol Myers Squibb’s commitment to develop innovative therapies for Canadians living with severe blood disorders.”

“Working with our partners at Bristol Myers Squibb, we are excited to help address the needs of Canadians living with MDS,” said Habib Dable, President and Chief Executive Officer of Acceleron. “By targeting the ineffective erythropoiesis associated with MDS, REBLOZYL® represents an important addition for the treatment of patients living with this condition.”

Health Canada’s approval of REBLOZYL® is based upon findings from the phase 3, double-blind, randomized, placebo-controlled MEDALIST study, which involved patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) requiring regular RBC transfusions (>2 RBC units per 8 weeks).1 The patients were randomized 2:1 to REBLOZYL® or placebo.1 In the trial, results demonstrated significantly greater percentage of patients treated with REBLOZYL® achieving transfusion independence for eight weeks or longer during the first 24 weeks of the trial as compared to placebo (38% vs. 13%, P<0.001) at primary endpoint.1

For more information about Bristol Myers Squibb global operations, visit www.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 400 people across the country. For more information, please visit www.bms.com/ca.

For more information about Bristol Myers Squibb, visit us at BMS.com

For more information, please visit www.acceleronpharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005710/en/

WHAT IS REBLOZYL® (luspatercept-aamt)?

REBLOZYL is a prescription medicine used to treat anemia (low red blood cells) in adults with:

beta thalassemia who need regular red blood cell (RBC) transfusions.
myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular RBC transfusions and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA).

REBLOZYL is not for use as a substitute for RBC transfusions in people who need immediate treatment for anemia. It is not known if REBLOZYL is safe or effective in children.

https://www.reblozyl.com/

Bristol Myers' REBLOZYL wins Health Canada approval for transfusion-dependent anemia

Feb. 16, 2021 10:02 AM ET Acceleron Pharma Inc. (XLRN)

By: Aakash Babu, SA News Editor

Bristol Myers Squibb Company (BMY -0.2%) Bristol Myers Squibb Canada and Acceleron Pharma (XLRN -2.6%)announce that Health Canada has approved REBLOZYL (luspatercept for injection) for the treatment of certain patients with transfusion-dependent anemia.

https://seekingalpha.com/news/3662262-bristol-myers-reblozyl-wins-health-canada-approval-for-transfusion-dependent-anemia

https://seekingalpha.com/symbol/BMY

WHAT IS REBLOZYL® (luspatercept-aamt)? REBLOZYL is a prescription medicine used to treat anemia (low red blood cells) in adults with: beta thalassemia who need regular red blood cell (RBC) transfusions. myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular RBC transfusions and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA). REBLOZYL is not for use as a substitute for RBC transfusions in people who need immediate treatment for anemia. It is not known if REBLOZYL is safe or effective in children.

ERLEADA® (apalutamide)

Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate CancerFinal analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease

RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.[1] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #11; Rapid Abstract Session: Prostate Cancer, February 11, 3:30 PM-4:15 PM EST).

Initial results from the TITAN study presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine showed the addition of ERLEADA® (apalutamide) to ADT compared to placebo plus ADT significantly improved the dual primary endpoints of OS and radiographic progression-free survival (rPFS) in patients with mCSPC.[2]

About the TITAN Study2
TITAN (NCT02489318) is a Phase 3, randomized, placebo-controlled, double-blind study in patients with mCSPC. The study included 1,052 patients in 23 countries across 260 sites in North America, Latin America, South America, Europe, and Asia Pacific.3 Patients with mCSPC were randomized 1:1 and received either ERLEADA® (240 mg) plus ADT (n=524), or placebo plus ADT (n=527). The recruitment period for the study spanned from December 2015 to July 2017.2 The study included patients with mCSPC with both low- and high-volume disease, those who were newly diagnosed, and those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for mCSPC. 2

ERLEADA® (apalutamide)

About ERLEADA® (apalutamide)
ERLEADA® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. ERLEADA® received U.S. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.2 To date, more than 10,000 patients worldwide have been treated with ERLEADA®. ERLEADA® is taken orally, once daily, with or without food. 2 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide (ERLEADA®) with continued androgen deprivation therapy**† as a Category 1 Preferred treatment option for patients with non-metastatic (M0) castration-resistant prostate cancer and a PSA doubling time (PSADT) ≤10 months.[5] The NCCN Guidelines® also include apalutamide (ERLEADA®) with androgen deprivation**† as a Category 1 Preferred treatment option for patients with metastatic (M1) castration-naive prostate cancer. ‡4 The American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) recommend clinicians offer apalutamide (ERLEADA®) with continued androgen deprivation therapy (ADT) as one of the treatment options for patients with nmCRPC at high risk for developing metastatic disease (Standard; Evidence Level Grade A)***.[6] ERLEADA® is being studied in five Phase 3 registrational clinical trials.

For more information about ERLEADA®, visit www.ERLEADA.com.

Please see the full Prescribing Information for ERLEADA®.

Learn more at www.janssen.com.

JNJ’s Erleada yields positive data in late-stage trial for prostate cancer

Feb. 09, 2021 7:16 AM ETJohnson & Johnson (JNJ)By: Dulan Lokuwithana, SA News Editor

The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ) has announced results from the final analysis of the Phase 3 TITAN study, a randomized, placebo-controlled, double-blind study conducted globally in patients with metastatic castration-sensitive prostate cancer (“mCSPC”).

https://seekingalpha.com/news/3659881-jnjs-erleada-yields-positive-data-in-late-stage-trial-for-prostate-cancer

https://seekingalpha.com/symbol/JNJ

https://www.erleada.com/

What is ERLEADA®? ERLEADA® (apalutamide) is a prescription medicine used for the treatment of prostate cancer: that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. It is not known if ERLEADA® is safe and effective in females. It is not known if ERLEADA® is safe and effective in children.

Opdivo (nivolumab)

Adjuvant Treatment with Opdivo (nivolumab) Demonstrates Statistically Significant and Clinically Meaningful Improvement in Disease-Free Survival in Patients with Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

02/08/2021CATEGORY:

Corporate/Financial News

Patients who received Opdivo after surgery lived nearly twice as long without disease recurrence compared to those who received placebo

With the positive results from CheckMate -274, Opdivo has shown benefit in Phase 3 trials across four different types of early resectable cancer

Data from CheckMate -274 to be presented for the first time at the 2021 Genitourinary Cancer Symposium

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -274 trial, which showed that Opdivo (nivolumab) significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and in the subgroup of patients whose tumors express PD-L1 ≥1%, meeting both of the study’s primary endpoints. CheckMate -274 is the first positive Phase 3 trial evaluating an immunotherapy in the adjuvant setting of muscle-invasive urothelial carcinoma.

Opdivo (nivolumab)

About Opdivo

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

https://www.opdivo.com/

Please see US Full Prescribing Information for OPDIVO and YERVOY.

For more information about Bristol Myers Squibb, visit us at BMS.com

Bristol Myers announces late-stage data for Opdivo in bladder cancer

Feb. 09, 2021 12:03 PM ETBristol-Myers Squibb Company (BMY)By: Dulan Lokuwithana, SA News Editor6 Comments

Bristol Myers Squibb (NYSE:BMY) announced that its immune checkpoint inhibitor, Opdivo (nivolumab), met both primary endpoints in a Phase 3 study in patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

https://seekingalpha.com/news/3660036-bristol-myers-announces-late-stage-data-for-opdivo-in-bladder-cancer

https://seekingalpha.com/symbol/BMY

https://www.opdivo.com/

Inrebic ® (fedratinib)

Bristol Myers Squibb Receives European Commission Approval for Inrebic® (fedratinib) for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis

02/08/2021CATEGORY:

Corporate/Financial News

Inrebic, a once-daily, oral therapy, is the first new treatment option approved in Europe for myelofibrosis in nearly a decade

Inrebic demonstrated clinically meaningful spleen and symptom response in myelofibrosis patients where treatment with ruxolitinib has failed, who are intolerant to ruxolitinib or who are JAK inhibitor naïve, based on results from JAKARTA and JAKARTA2 studies

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted full Marketing Authorization for Inrebic® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Inrebic is the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed, who are intolerant to ruxolitinib or who are JAK inhibitor naïve. The centralized Marketing Authorization approves use of Inrebic in all European Union (EU) member states, as well as Norway, Iceland and Liechtenstein.* Inrebic was granted orphan drug designation in the United States and is also approved in the United States and Canada. 1,2

Inrebic ® (fedratinib)

About Inrebic
Inrebic ® (fedratinib) is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Inrebic is a JAK2-selective inhibitor with higher potency for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms, including myelofibrosis and polycythemia vera. In cell models expressing mutationally active JAK2 or FLT3, Inrebic reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. In mouse models of JAK2V617F-driven myeloproliferative disease, Inrebic blocked phosphorylation of STAT3/5, increased survival and improved disease-associated symptoms, including reduction of white blood cells, hematocrit, splenomegaly and fibrosis.1

U.S. INDICATION
INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

https://www.inrebic.com/

Please see full Prescribing Information, including Boxed WARNING, and Summary of Product Characteristics for INREBIC.

For more information about Bristol Myers Squibb, visit us at BMS.com

Bristol Myers Squibb's Inrebic nabs European Commission approval

Feb. 08, 2021 12:36 PM ET

Bristol-Myers Squibb Company (BMY)

By: Aakash Babu, SA News Editor4 Comments

https://seekingalpha.com/news/3659568-bristol-myers-squibbs-inrebic-nabs-european-commission-approval

https://seekingalpha.com/symbol/BMY

Indication What is INREBIC® (fedratinib)? INREBIC is a prescription medicine used to treat adults with certain types of myelofibrosis (MF). It is not known if INREBIC is safe and effective in children.

OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)

OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial

02/08/2021CATEGORY:

Corporate/Financial News

With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib

Patients treated with OPDIVO in combination with CABOMETYX report significantly improved health-related quality of life in a separate analysis from CheckMate -9ER

Data showing ongoing efficacy benefits and patient-reported outcomes will be presented at the 2021 Genitourinary Cancers Symposium

PRINCETON, N.J., & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of OPDIVO® (nivolumab) and CABOMETYX® (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC). These data will be presented in two posters at the virtual American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium from February 11 to 13, 2021 and featured in the Poster Highlights Session on February 13, 2021 from 9:00 a.m. – 9:45 a.m. EST.

Abstract #308: Nivolumab + cabozantinib (NIVO+CABO) vs. sunitinib (SUN) for advanced renal cell carcinoma (aRCC): outcomes by sarcomatoid histology and updated trial results with extended follow-up of CheckMate -9ER (Motzer, et. al.)

OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)

About OPDIVO®

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

OPDIVO® INDICATIONS

https://www.opdivo.com/

CABOMETYX® INDICATIONS

CABOMETYX®(cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

CABOMETYX®(cabozantinib) is indicated for the treatment of patients with advanced RCC, as a first-line treatment in combination with nivolumab.

CABOMETYX®(cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

https://www.cabometyx.com/

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

For more information about Bristol Myers Squibb, visit us at BMS.com

Bristol Myers announce new late-stage data for Opdivo/ Cabometyx combo in kidney cancer

Feb. 09, 2021 3:47 PM ETBristol-Myers Squibb Company (BMY)By: Dulan Lokuwithana, SA News Editor13 Comments

Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ:EXEL) disclosed new data for Opdivo/ Cabometyx combo in a pivotal Phase 3 trial for the first-line treatment of advanced renal cell carcinoma.

https://seekingalpha.com/news/3660157-bristol-myers-announce-new-late-stage-data-for-opdivo-cabometyx-combo-in-kidney-cancer

https://seekingalpha.com/symbol/BMY

https://www.exelixis.com/

https://seekingalpha.com/symbol/EXEL

Press Release « Back View printer-friendly version Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma PDF Version – Results of retrospective analysis demonstrate a 61% intracranial response rate in patients with progressing brain metastases – – Data to be presented during the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium – ALAMEDA, Calif.--(BUSINESS WIRE)--Feb. 8, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX® (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC). The findings will be presented as part of the Poster Session: Renal Cell Cancer at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021. All posters will be available on demand beginning at 5:00 a.m. PT on Thursday, February 11.

biotecMAX™ January & February 2021 Insight

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021

NEW BRUNSWICK, N.J., February 4, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization.

Janssen’s Investigational COVID-19 Vaccine
The Janssen investigational COVID-19 vaccine leverages the Company’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines. The safety profile observed was consistent with other investigational vaccines using Janssen’s AdVac® technology among more than 200,000 people to date.

Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years old and older. The study was designed to evaluate the safety and efficacy of the Janssen investigational vaccine in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

The trial, conducted in eight countries across three continents, includes a diverse and broad population.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

Learn more at www.jnj.com. Follow us at @JNJNews.

Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Johnson & Johnson applies for emergency use OK for COVID-19 vaccine

Feb. 04, 2021 5:55 PM ETJohnson & Johnson (JNJ) By: Jason Aycock, SA News Editor83 Comments

Johnson & Johnson (NYSE:JNJ) has applied to the FDA for emergency use authorization for its single-shot COVID-19 vaccine. https://seekingalpha.com/news/3658893-johnson-johnson-applies-for-emergency-use-ok-for-covid-19-vaccine

https://seekingalpha.com/symbol/JNJ

EMA receives application for conditional marketing authorization of COVID-19 Vaccine Janssen

16/02/2021

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.

https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

https://apnews.com/article/coronavirus-pandemic-coronavirus-vaccine-0bbaa5693035bab95cf4ccf9c8d3b98f Click to copy RELATED TOPICS Business U.S. News AP Top News Health Coronavirus pandemic Latin America Africa Coronavirus vaccine J&J asks US regulators to OK its one-shot COVID-19 vaccine By LAURAN NEERGAARD

Johnson & Johnson applies for emergency use authorization of COVID vaccine

•Feb 4, 2021 CBS News CBS News

Johnson & Johnson submits application to FDA for vaccine authorization

Feb 4, 2021 CNBC Television CNBC Television

TYVYT® (sintilimab injection)

Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Pemetrexed and Platinum Chemotherapy as First-Line Therapy for Nonsquamous Non-Small Cell Lung Cancer

Publish at：Feb 3 2021

SAN FRANCISCO, U.S. and SUZHOU, China, February 3, 2021 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company (“Lilly”, NYSE: LLY), today jointly announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) of TYVYT® (sintilimab injection) in combination with pemetrexed and platinum chemotherapy as first-line therapy for people with nonsquamous non-small cell lung cancer (nsqNSCLC). This is the second approved indication of TYVYT® (sintilimab injection) in China, following the first approved indication by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy.

TYVYT® (sintilimab injection)

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. In December 2018, TYVYT® (sintilimab injection) was first approved by the China NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy. In February 2021, TYVYT® (sintilimab injection) was approved by the China NMPA in combination with pemetrexed and platinum chemotherapy as first-line therapy for the treatment of nonsquamous non-small cell lung cancer. TYVYT® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

Currently TYVYT® (sintilimab injection) has three supplemental New Drug Applications (“sNDA") under review by the NMPA. In August 2020, the NMPA accepted sNDA for TYVYT® (sintilimab injection) in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In January 2021, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab injection) as first-line therapy in Hepatocellular Carcinoma (HCC) and the sNDA for TYVYT® (sintilimab injection) as second-line therapy in squamous NSCLC. Besides, in May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma.

TYVYT® (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT® (sintilimab injection) worldwide.

For more information, please visit: www.innoventbio.com.

To learn more about Lilly, please visit www.lilly.com

license for TYVYT® (sintilimab injection) for geographies outside of China and plans to pursue registration of TYVYT® (sintilimab injection) in the U.S. and other markets.

http://innoventbio.com/en/#/pline

Lilly, Innovent Bio's Tyvyt + chemotherapy OK'd in China for lung cancer

Feb. 03, 2021 12:33 AM ETEli Lilly and Company (LLY)By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3657589-lilly-innovent-bios-tyvyt-chemotherapy-okd-in-china-for-lung-cancer

https://seekingalpha.com/symbol/LLY

ROBUST PIPELINE ACROSS NOVEL THERAPEUTICS AND BIOSIMILARS

#BBC #BBCiPlayer #BBCNews

Covid-19: Novavax vaccine shows 89% efficacy in UK trials 🔴 @BBC News live - BBC

•Jan 29, 2021

Novavax Expects Vaccinations to Begin in U.K. in April: CEO

•Jan 29, 2021 Bloomberg Markets and Finance

NVX-CoV2373

Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization

Feb 04, 2021 at 4:05 PM EST Download PDF

Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada

GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.

NVX-CoV2373

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

For more information, visit www.novavax.com

Regulatory authorities initiate rolling review of Novavax's COVID-19 vaccine

Feb. 05, 2021 4:20 AM ET Novavax, Inc. (NVAX) By: Mamta Mayani, SA News Editor4 Comments

Multiple regulatory agencies have started the rolling review process for authorization of Novavax's (NASDAQ:NVAX) COVID-19 vaccine, NVX-CoV2373.

https://seekingalpha.com/news/3658949-regulatory-authorities-initiate-rolling-review-process-for-authorization-of-novavaxs-covid-19-vaccine

Novavax Announces Expanded Collaboration and License Agreement with SK Bioscience for 40 Million Doses of COVID-19 Vaccine for South Korea

Feb 15, 2021 at 8:04 PM EST Download PDF Existing partnership for manufacture of NVX-CoV2373 expanded to increase production capacity and supply vaccine to the Korean Government

GAITHERSBURG, Md., Feb. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, and SK Bioscience, a vaccine business subsidiary of SK Group, today announced an expanded collaboration and license agreement. In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373, Novavax’ COVID-19 vaccine, for sale to the Korean government. SK Bioscience will add significant production capacity under this new agreement. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing Phase 3 clinical trial in the United Kingdom and is also currently conducting a Phase 3 trial in the U.S. and Mexico.

https://ir.novavax.com/news-releases/news-release-details/novavax-announces-expanded-collaboration-and-license-agreement

https://seekingalpha.com/symbol/NVAX

NVX-CoV2373 Matrix M Coronavirus

#Coronavirus #Vaccine #TODAY

Pfizer, Moderna And J&J COVID-19 Vaccines: What Are The Differences? | TODAY

Feb 6, 2021 TODAY

COVID-19 Vaccine

Sinovac Announces Phase III Results of Its COVID-19 Vaccine

Date: 2021-02-05
Pageview: 4827

February 05, 2021 04:05 PM Eastern Standard Time

BEIJING--Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced phase III results. Sinovac had started its phase III trials on CoronaVac, its COVID-19 vaccine, on July 21, 2020. Trials were conducted in Brazil, Turkey, Indonesia, and Chile. In compliance with the principles of Good Clinical Practice (GCP), the trials were conducted with the vaccine candidate produced from the same lot and following the 0, 14 day schedule. There have been a total of 25,000 participants enrolled in the trial across those four countries.

For more information please see the Company’s website at www.sinovac.com.

COVID-19 Vaccine

Sinovac’s announces late-stage data for COVID-19 vaccine candidate

Feb. 05, 2021 4:56 PM ET

Sinovac Biotech Ltd. (SVA)

By: Dulan Lokuwithana, SA News Editor2 Comments

Based on results from late-stage trials, Sinovac Biotech (NASDAQ:SVA) says its COVID-19 vaccine candidate demonstrated a 100% efficacy against hospitalized, severe, and fatal cases of COVID-19.

https://seekingalpha.com/news/3659262-sinovacs-announces-late-stage-data-for-covid-19-vaccine

https://seekingalpha.com/symbol/SVA

https://www.sinovacbio.cn/

http://www.sinovac.com.cn/

Human Vaccines

Breyanzi (lisocabtagene maraleucel)

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma

02/05/2021

CATEGORY:

Corporate/Financial News

Breyanzi demonstrated a 73% overall response rate and 54% complete response (CR) rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial

Breyanzi demonstrated sustained responses in patients who achieved a CR with median duration of response not reached

G rade ≥3 cytokine release syndrome and Grade ≥3 neurologic toxicities following Breyanzi treatment occurred in 4% and 12% of patients, respectively

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.1Breyanzi is a CD19-directed CAR T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4‑1BB signaling enhances the expansion and persistence of Breyanzi. Breyanzi offers a potentially definitive treatment. A single dose of Breyanzi contains 50 to 110 x 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components). Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS) and Neurologic Toxicities (NT).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210205005520/en/

Breyanzi (lisocabtagene maraleucel)

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-888-423-5436.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

https://www.breyanzirems.com/

For more information about Bristol Myers Squibb, visit us at BMS.com

Bristol Myers Squibb wins FDA approval for lymphoma treatment Breyanzi

Feb. 05, 2021 4:13 PM ET Bristol-Myers Squibb Company (BMY) By: Dulan Lokuwithana, SA News Editor22 Comments

The FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) from Bristol Myers Squibb (NYSE:BMY) for patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

https://seekingalpha.com/news/3659240-bristol-myers-squibb-receives-fda-approval-for-liso-cel

https://seekingalpha.com/symbol/BMY

Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod

by Eric Sagonowsky | Feb 5, 2021 3:38pm

https://www.fiercepharma.com/pharma/after-delays-and-a-cvr-miss-bristol-s-liso-cel-wins-its-fda-nod

Indication BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma, after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B‑cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Uliledlimab (TJD5)

I-Mab Announces Multiple Clinical Advancements of its Differentiated CD73 Antibody Uliledlimab in China and the U.S.

First patient dosed in a combination study with anti-PD1 in China

Topline results from U.S. phase 1 study demonstrate safety and clinical activity

Data from preclinical and clinical studies to be presented at conferences this year

SHANGHAI, China and GAITHERSBURG, MD. – February 5, 2021 – I-Mab (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors. The Company plans to present detailed clinical results at select scientific conferences this year.

Uliledlimab (TJD5)

About Uliledlimab (TJD5)

Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-1 and PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

For more information, please visit http://ir.i-mabbiopharma.com

I-Mab updates on advancement of uliledlimab in china and U.S.

Feb. 05, 2021 8:59 AM ETI-Mab (IMAB)

By: Mamta Mayani, SA News Editor

I-Mab (NASDAQ:IMAB) announces multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors.

https://seekingalpha.com/news/3659070-i-mab-updates-on-advancement-of-uliledlimab-in-china-and-us

I-Mab Announces Multiple Clinical Advancements of Its Differentiated CD73 Antibody Uliledlimab in China and the U.S. By I-Mab Feb 5, 2021

https://www.heraldmailmedia.com/news/state/i-mab-announces-multiple-clinical-advancements-of-its-differentiated-cd73-antibody-uliledlimab-in-china-and/article_6a89cad2-c662-554e-aea3-77d836af8769.html

https://www.i-mabbiopharma.com/en/Pipeline.aspx

https://seekingalpha.com/symbol/IMAB

Pipeline Strategy and Progress Our pipeline strategy is to build a risk-controlled clinical-stage pipeline with an exclusive focus on novel or highly differentiated biologics. To achieve a delicate balance between exclusive positioning of highly innovative therapeutics and the related development risk, we have built a globally competitive biologics pipeline comprising a risk-controlled and “fast-to-market” China Portfolio and a transformational “fast-to-PoC (proof of concept)” Global Portfolio.

RAPIVAB® (peramivir injection)

BioCryst Announces FDA Approval of Supplemental New Drug Application for RAPIVAB® Expanding Patient Population to Include Children Six Months and Older

PDF Version

RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for RAPIVAB® (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.

RAPIVAB® (peramivir injection)

About RAPIVAB® (peramivir injection)
RAPIVAB (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. It is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg/kg for adults and adolescents and 12 mg/kg for pediatric patients ages six months to 12 years. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.

U.S. Indication and Important Safety Information

Indication

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.

Please see full prescribing information for RAPIVAB.

For more information, please visit the company’s website at www.biocryst.com.

https://www.rapivab.com/

BioCryst climbs after FDA approval for Rapivab in infants

Feb. 03, 2021 7:26 AM ET BioCryst Pharmaceuticals, Inc. (BCRX)

By: Dulan Lokuwithana, SA News Editor8 Comments

BioCryst Pharmaceuticals (NASDAQ:BCRX) has gained ~6.6% in the premarket trading after the company announced that the FDA approved a supplemental new drug application for Rapivab® (peramivir injection), extending its use in patients aged six months and older.

https://seekingalpha.com/news/3657683-biocryst-climbs-after-fda-approval-for-rapivab-in-infants

https://seekingalpha.com/symbol/BCRX

Indication RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.

biotecMAX™ January 2021 Insight

COVID-19 single-shot vaccine

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination 85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28 Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage1 Observed in South Africa Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data

Janssen’s Vaccine Technology The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. The Janssen AdVac® viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable. Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol. ENSEMBLE has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

Learn more at www.jnj.com.

Learn more at www.janssen.com

Johnson & Johnson COVID-19 vaccine 66% effective in global trial

Jan. 29, 2021 8:16 AM ET Johnson & Johnson (JNJ) By: Jonathan M Block, SA News Editor138 Comments

A large global trial showed that Johnson & Johnson's (NYSE:JNJ) single-shot vaccine was 66% effective in preventing moderate-to-severe COVID-19 a large global trial.

https://seekingalpha.com/news/3656132-johnson-johnson-covid-19-vaccine-66-effective-in-global-trial

FEBRUARY 14, 202110:20 PMUPDATED A DAY AGO

J&J's vaccine implementation study in S.Africa gets regulator nod

By Wendell Roelf CAPE TOWN (Reuters)

https://www.reuters.com/article/us-health-coronavirus-safrica-j-j-idUSKBN2AF0CF?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link&taid=602a4c09bbd8010001ee5fb6&utm_campaign=trueAnthem%3A%2BTrending%2BContent&utm_medium=trueAnthem&utm_source=twitter

https://www.janssen.com/

https://seekingalpha.com/symbol/JNJ

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial Jan 29, 2021 United States Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination 85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28 Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage[1] Observed in South Africa Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

Deucravacitinib

Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)

02/02/2021CATEGORY:

Corporate/Financial News

Superiority of deucravacitinib was demonstrated on both co-primary endpoints and multiple key secondary endpoints in the POETYK PSO-2 trial

The overall safety profile remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced positive results from POETYK PSO-2, the second pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-2 evaluated deucravacitinib 6 mg once daily and met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI 75), defined as at least a 75 percent improvement of baseline PASI, and a static Physician's Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.

Deucravacitinib

About Deucravacitinib

Deucravacitinib is the first and only novel, once daily, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to be a selective TYK2 inhibitor, inhibiting interleukin (IL)-12, IL-23 and Type 1 interferon (IFN) pathways, which are implicated in the pathogenesis of psoriasis and other immune-mediated diseases. Deucravacitinib achieves selectivity by binding to the regulatory domain of TYK2, which is structurally distinct from the Janus kinase (JAK) 1, 2 and 3 kinases. Deucravacitinib does not inhibit JAK 1, 2, 3 at clinically relevant concentrations. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for any use in any country.

For more information about Bristol Myers Squibb, visit us at BMS.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210202005374/en/

https://www.biospace.com/article/releases/bristol-myers-squibb-announces-positive-topline-results-from-second-pivotal-phase-3-psoriasis-study-showing-superiority-of-deucravacitinib-compared-to-placebo-and-otezla-apremilast-/

Bristol Myers announces positive data for deucravacitinib in plaque psoriasis

Feb. 02, 2021 8:08 AM ET Bristol-Myers Squibb Company (BMY) By: Dulan Lokuwithana, SA News Editor2 Comments

Bristol Myers Squibb (NYSE:BMY) is up ~1.6% in premarket after the company announced positive topline results from a pivotal Phase 3 trial evaluating deucravacitinib for the treatment of moderate to severe plaque psoriasis.

https://seekingalpha.com/news/3657156-bristol-myers-announced-positive-data-for-deucravacitinib-in-plaque-psoriasis

https://seekingalpha.com/symbol/BMY

Our Pipeline at a Glance As of November 17, 2020

Zeposia® (ozanimod)

Bristol Myers Squibb Application for Zeposia® (ozanimod) for the Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by U.S. Food and Drug Administration

02/01/2021CATEGORY:

Corporate/Financial News

U.S. Food and Drug Administration assigned an action date of May 30, 2021

Supplemental New Drug Application is supported by positive results from the pivotal Phase 3 True North study evaluating oral Zeposia (ozanimod) in adults with moderately to severely active ulcerative colitis

If approved, Zeposia would be the first oral sphingosine-1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zeposia® (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Following the redemption of a Priority Review Voucher with the submission, the FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2021.

Zeposia® (ozanimod)

About Zeposia ® (ozanimod)

Zeposia ® (ozanimod) is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to exit from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa.

Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis. The company is also investigating Zeposia forthe treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.

Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020. The European Medicines Agency validated Bristol Myers Squibb’s Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020. Zeposia is not approved for the treatment of ulcerative colitis in any country.

For additional safety information, please see the full Prescribing Information and Medication Guide.

https://www.zeposia.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210201005105/en/

https://www.bms.com/

Bristol Myers granted priority review for Zeposia in ulcerative colitis

Feb. 01, 2021 12:48 PM ET

Bristol-Myers Squibb Company (BMY) By: Dulan Lokuwithana, SA News Editor

Bristol Myers Squibb (BMY +1.5%) announced that the FDA has accepted the supplemental New Drug Application ("sNDA") for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis.

https://seekingalpha.com/news/3656767-bristol-myers-granted-priority-review-for-zeposia-in-ulcerative-colitis

https://seekingalpha.com/symbol/BMY

INDICATION ZEPOSIA® (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if ZEPOSIA is safe and effective in children. Please see full Prescribing Information, including Medication Guide.

KRASG12C inhibitor sotorasib

Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China

Sotorasib is for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS G12C Mutation

THOUSAND OAKS, Calif., Jan. 29, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that its investigational KRASG12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen's strategic collaboration with BeiGene.

KRASG12C inhibitor sotorasib

About CodeBreaK
The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled nearly 700 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

For more information, visit www.amgen.com

To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

A robust pipeline leveraging state-of-the-art science and molecular engineering focused on the pursuit of transformative medicines with large effects in serious diseases. Human genetic validation is used to strengthen the evidence base of as many of our programs as possible.

PIPELINE

https://www.amgenpipeline.com/

https://seekingalpha.com/symbol/AMGN

Clinically Meaningful Benefit in Advanced KRAS G12C+ NSCLC Is Seen With Sotorasib January 30, 2021 Gina Mauro

REGEN-COV (casirivimab and imdevimab)

January 27, 2021 at 7:00 AM EST Back

REGEN-COV™ ANTIBODY COCKTAIL IS ACTIVE AGAINST SARS-COV-2 VARIANTS FIRST IDENTIFIED IN THE UK AND SOUTH AFRICA

TARRYTOWN, N.Y., Jan. 27, 2021 /PRNewswire/ --

Columbia University researchers and Regeneron have independently confirmed findings; data included in bioRxiv paper and submitted for peer-reviewed publication

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that researchers in Dr. David Ho's Columbia University lab and Regeneron scientists have independently confirmed that REGEN-COVTM (casirivimab and imdevimab antibody cocktail) successfully neutralizes the circulating SARS-CoV-2 variants first identified in the UK (B.1.1.7) and South Africa (B.1.351). Columbia's findings were included in a paper posted to bioRxiv and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to antibody neutralization.

REGEN-COV (casirivimab and imdevimab)

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

In November 2020, REGEN-COV received Emergency Use Authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have high viral load. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., casirivimab and imdevimab are not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

Authorized Emergency Use
Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. Safety and effectiveness of casirivimab and imdevimab injection have not yet been established for the treatment of COVID-19.

Limitations of Authorized Use

Casirivimab and imdevimab injection is not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Benefit of treatment with casirivimab and imdevimab injection has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

For additional information about the company, please visit www.regeneron.com

View original content:http://www.prnewswire.com/news-releases/regen-cov-antibody-cocktail-is-active-against-sars-cov-2-variants-first-identified-in-the-uk-and-south-africa-301215816.html

REGEN-COV™ Antibody Cocktail Is Active Against SARS-CoV-2 Variants First Identified in the UK and South Africa

Wed January 27, 2021 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Jan. 27, 2021 /PRNewswire/ --

Columbia University researchers and Regeneron have independently confirmed findings; data included in bioRxiv paper and submitted for peer-reviewed publication

https://seekingalpha.com/pr/18166860-regen-cov-antibody-cocktail-is-active-against-sars-covminus-2-variants-first-identified-in-uk

Regeneron’s antibody cocktail neutralizes new COVID-19 variants

Jan. 27, 2021 7:40 AM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Dulan Lokuwithana, SA News Editor

Citing research findings, Regeneron Pharmaceuticals (NASDAQ:REGN) says that its REGEN-COVTM (casirivimab and imdevimab antibody cocktail) neutralizes the circulating SARS-CoV-2 variants first identified in the U.K. (B.1.1.7) and South Africa (B.1.351).

https://seekingalpha.com/news/3654838-regenerons-antibody-cocktail-neutralizes-new-covid-19-variants

https://seekingalpha.com/symbol/REGN

INTERACT WITH THE REGENERON PIPELINE Pipeline last updated: November 25, 2020

NVX-CoV2373, its protein-based COVID-19 vaccine candidate

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

Jan 28, 2021 at 4:05 PM ESTDownload PDF

First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
Company to host investor conference call today at 4:30pm ET

GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

NVX-CoV2373, its protein-based COVID-19 vaccine candidate

UK Phase 3 Results: 89.3% Efficacy

The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

South Africa Results: Approximately 90% of COVID-19 cases attributed to South Africa escape variant

In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

About NVX-CoV2373

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

For more information, visit www.novavax.com

Novavax's COVID-19 vaccine shows 89% efficacy in UK, 60% in South Africa

Jan. 28, 2021 4:25 PM ETNovavax, Inc. (NVAX)By: Vandana Singh, SA News Editor58 Comments

Novavax's (NASDAQ:NVAX) COVID-19 vaccine candidate demonstrated 60% efficacy in Phase 2b trial in South Africa.“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant", said principal investigator of the trial. Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant.

https://seekingalpha.com/news/3655832-novavaxs-covid-19-vaccine-shows-89-efficacy-in-uk-60-in-south-africa

Novavax’s Vaccine Works Well, Except on Variant Found in South Africa

An analysis in Britain found that the vaccine had an efficacy rate of nearly 90 percent. In a South Africa trial, the rate dropped to under 50 percent.

https://seekingalpha.com/symbol/NVAX

Using the power of our technology to create tomorrow’s vaccines today.

KEYTRUDA® (pembrolizumab)

European Commission Approves KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Save

January 26, 2021 6:45 am EST

KEYTRUDA Is First Checkpoint Inhibitor Approved in Europe to Treat MSI-H or dMMR Colorectal Cancer

European Approval Based on Results From KEYNOTE-177 Trial Demonstrating KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 40% Compared With Chemotherapy

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

KEYTRUDA® (pembrolizumab)

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

Urothelial Carcinoma

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

Hepatocellular Carcinoma

Merkel Cell Carcinoma

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

https://www.keytruda.com/

For more information, visit www.merck.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005148/en/

Merck’s Keytruda gets European approval in colorectal cancer

Jan. 26, 2021 7:24 AM ETMerck & Co., Inc. (MRK)By: Dulan Lokuwithana, SA News Editor1 Comment

Merck (NYSE:MRK) announced that the European Commission has approved Keytruda as a monotherapy for adults with colorectal cancer.

https://seekingalpha.com/news/3654260-mercks-keytruda-gets-european-approval-in-colorectal-cancer

https://seekingalpha.com/symbol/MRK

KEYTRUDA. SELECT A TYPE OF CANCER Search by cancer type or name Advanced non–small cell lung cancer Melanoma Head and neck squamous cell cancer High-risk non-muscle invasive bladder cancer (NMIBC) Advanced urothelial bladder cancer Advanced kidney cancer (RCC) Advanced MSI-H/dMMR colorectal cancer Microsatellite instability-high cancer (MSI-H/dMMR) Classical Hodgkin lymphoma (cHL) Advanced gastric cancer Advanced cervical cancer Primary mediastinal B‑cell lymphoma (PMBCL) Advanced liver cancer (HCC) Advanced Merkel cell carcinoma Advanced esophageal squamous cell carcinoma Cutaneous squamous cell carcinoma (cSCC)

Mobocertinib (TAK-788)

Takeda Presents Positive Results For Mobocertinib in Patients with EGFR Exon20 insertion+ mNSCLC Who Received Prior Platinum-based Chemotherapy

Mobocertinib, an oral targeted therapy, demonstrated clinically meaningful responses, with a confirmed objective response rate of 35% as assessed by investigator and 28% as assessed by an independent review committee (IRC)
Responses shown with mobocertinib were durable, with a median duration of response of 17.5 months as assessed by IRC
Results represent encouraging progress in a patient population for which no approved targeted therapies exist

January 28, 2021 02:44 PM Eastern Standard Time

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) will be presented as a late-breaking oral session at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) on Friday, January 29 SGT.

Mobocertinib (TAK-788)

About Mobocertinib (TAK-788)

Mobocertinib, an oral therapy, is a potent, small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with human EGFR 2 (HER2) mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Drug Review Center (CDE) for the same indication.

For more information, visit www.takedaoncology.com.

For more information, visit https://www.takeda.com.

Takeda Presents Positive Results For Mobocertinib in Patients with EGFR Exon20 insertion+ mNSCLC Who Received Prior Platinum-based Chemotherapy

Thu January 28, 2021 8:00 AM|Business Wire|About: TAK

Mobocertinib, an oral targeted therapy, demonstrated clinically meaningful responses, with a confirmed objective response rate of 35% as assessed by investigator and 28% as assessed by an independent review committee (IRC)
Responses shown with mobocertinib were durable, with a median duration of response of 17.5 months as assessed by IRC
Results represent encouraging progress in a patient population for which no approved targeted therapies exist

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK) (“Takeda”)

https://seekingalpha.com/pr/18169097-takeda-presents-positive-results-for-mobocertinib-in-patients-egfr-exon20-insertion-mnsclc

https://seekingalpha.com/symbol/TAK

Our Pipeline

Tislelizumab (BGB-A317)

BeiGene Announces Positive Topline Results for Global Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma

January 27, 2021 at 5:45 PM EST

Tislelizumab prolonged the survival of patients with advanced unresectable or metastatic ESCC who received prior systemic treatment compared to chemotherapy

Safety findings of tislelizumab were consistent with known risks

CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--Jan. 27, 2021-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the global Phase 3 RATIONALE 302 trial of its anti-PD-1 antibody tislelizumab versus investigator’s choice chemotherapy in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic treatment met its primary endpoint of overall survival (OS). In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy. The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified.

Tislelizumab (BGB-A317)

About Tislelizumab

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, two supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan, and the transaction is expected to close in the first quarter of 2021, subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Tislelizumab is not approved for use outside of China.

To learn more about BeiGene, please visit www.beigene.com

BeiGene's tislelizumab shows survival benefit in esophageal cancer study

Jan. 28, 2021 9:33 AM ET BeiGene, Ltd. (BGNE) By: Vandana Singh, SA News Editor1 Comment

BeiGene (NASDAQ:BGNE) has announced data from global Phase 3 RATIONALE 302 trial evaluating its anti-PD-1 antibody, tislelizumab, in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

https://seekingalpha.com/news/3655594-beigenes-tislelizumab-shows-survival-benefit-in-esophageal-cancer-study?v=1611845089#comment-87810099

https://seekingalpha.com/symbol/BGNE

bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016)

New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent

January 26, 2021 Download PDF- BLAZE-1 trial met primary endpoint and key secondary endpoints with high statistical significance
- Results from more than 1,000 high-risk patients were consistent with previous data
- Findings from BLAZE-4 trial provide data on lower doses of bamlanivimab and etesevimab together
- Media and investor call "SARS-CoV-2 Neutralizing Antibody Program Update" to be held at noon EST today; details below

INDIANAPOLIS, Jan. 26, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths (collectively, "events") in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase 3 BLAZE-1 trial, Eli Lilly and Company (NYSE: LLY) announced. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together.

bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016)

Availability and supply
Bamlanivimab is authorized for emergency use by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in high-risk patients, and it has also been granted authorizations in several additional countries. For more information about the use of bamlanivimab in the U.S., contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit covid.infusioncenter.org or the HHS Therapeutic Distribution locator to find a potential treatment location, or visit combatcovid.hhs.gov to find out more about antibody therapy.

Important Information about bamlanivimab
Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

Bamlanivimab is authorized under an Emergency Use Authorization (EUA) only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About BLAZE-4
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab and etesevimab together, at various doses, versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

To learn more about Lilly, please visit us at www.lilly.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/new-data-show-treatment-with-lillys-neutralizing-antibodies-bamlanivimab-ly-cov555-and-etesevimab-ly-cov016-together-reduced-risk-of-covid-19-hospitalizations-and-death--by-70-percent-301214598.html

Lilly bamlanivimab combo therapy lowers COVID-19 hospitalizations, death by 70%

Jan. 26, 2021 9:42 AM ETEli Lilly and Company (LLY)By: Vandana Singh, SA News Editor

Eli Lilly (LLY -0.02%) reports new data from Phase 3 Blaze-1 trial, evaluating bamlanivimab and etesevimab antibody combination in critically-ill COVID-19 patients.

https://seekingalpha.com/news/3654378-lilly-combo-therapy-reduced-covid-hospitalizations-death-by-70

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)

https://clinicaltrials.gov/ct2/show/NCT04427501

Eli Lilly secures $625M Army contract modification for 50K doses of LY-CoV555

Jan. 27, 2021 5:23 PM ET Eli Lilly and Company (LLY) By: Akanksha Bakshi, SA News Editor

Eli Lilly (NYSE:LLY) has been awarded a $625M modification to contract for 500,000 doses of LY-CoV555, a COVID-19 therapeutic drug treatment.

https://seekingalpha.com/news/3655282-eli-lilly-secures-625m-army-contract-modification-for-50k-doses-of-ly-cov555

ARMY

Eli Lilly and Co., Indianapolis, Indiana, was awarded a $625,000,000 modification (P00007) to contract W911QY-21-C-0016 for 500,000 doses of LY-CoV555, a COVID-19 therapeutic drug treatment. Work will be performed in Indianapolis, Indiana, with an estimated completion date of Jan. 27, 2021. Fiscal 2021 Coronavirus Aid, Relief and Economic Security Act funds in the amount of $625,000,000 were obligated at the time of the award. U.S. Army Contracting Command, Aberdeen Proving Ground, Maryland, is the contracting activity. (Awarded Jan. 26, 2021)

https://www.defense.gov/Newsroom/Contracts/Contract/Article/2484774/?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

https://seekingalpha.com/symbol/LLY

Your COVID-19 Treatment Journey: Our Antibodies Might Help Eli Lilly and Company

TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

Vertex Announces U.S. FDA Acceptance of Supplemental New Drug Application for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations

-FDA grants Priority Review of the application and sets a PDUFA target action date of June 8, 2021-

BOSTON--(BUSINESS WIRE)--Jan. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) to expand the use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 8, 2021. The submission was supported by data from a global Phase 3 study of TRIKAFTA in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation.

TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

What is TRIKAFTA?

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age.

Patients should not take TRIKAFTA if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; seizure medications such as phenobarbital, carbamazepine, or phenytoin; or St. John’s wort.

What is TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)?

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 12 years of age.

https://www.trikafta.com/

For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005646/en/

Vertex sNDA for cystic fibrosis drug Trikafta accepted by FDA

Jan. 26, 2021 11:10 AM ET Vertex Pharmaceuticals Incorporated (VRTX)By: Jonathan M Block, SA News Editor5 Comments

The FDA has accepted an sNDA from Vertex (NASDAQ:VRTX) for Trikafta to treat children 6 to 11 years old that have cystic fibrosis with a certain genetic mutation.

https://seekingalpha.com/news/3654333-vertex-snda-for-cystic-fibrosis-drug-trikafta-accepted-by-fda

https://news.vrtx.com/

https://seekingalpha.com/symbol/VRTX

What is TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)? TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Talk to your doctor to learn if you have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age.

RINVOQ™ (Upadacitinib)

January 25, 2021

European Commission Approves AbbVie's RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis

- RINVOQ (15 mg, once daily) is the first oral, once-daily, selective and reversible JAK inhibitor approved for three adult rheumatic indications in the European Union: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis[1,2]
- Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where RINVOQ met all primary and met key secondary endpoints with a safety profile consistent with that seen in rheumatoid arthritis[2-6]
- Approvals underscore AbbVie's longstanding commitment to deliver innovative medicines for people living with rheumatic diseases

NORTH CHICAGO, Ill., Jan. 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.1 The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ's efficacy across multiple measures of disease activity.* 4-6

Top-line results from SELECT-PsA 1 were previously announced in February 2020. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).

Top-line results from SELECT-PsA 2 were previously announced in October 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).

Results from SELECT-AXIS 1 were previously announced in November 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03178487).

About RINVOQ™ (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,17-27 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.17, 20-27

USE

https://www.rinvoq.com/

Please see the full SmPC for complete prescribing information at www.EMA.europa.eu.

For more information about AbbVie, please visit us at www.abbvie.com

https://seekingalpha.com/symbol/ABBV

biotecMAX™ January 2021 Insight

BAVENCIO® (AVELUMAB)

EUROPEAN COMMISSION APPROVES BAVENCIO® (AVELUMAB) FOR FIRST-LINE MAINTENANCE TREATMENT OF LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA

Not intended for UK-based media

Monday, January 25, 2021 - 02:00amEST

BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase III JAVELIN Bladder 100 study
First and only immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III trial
BAVENCIO first-line maintenance therapy is recommended for use by the ESMO Bladder Cancer Guidelines

Rockland, MA and New York, US, January 25, 2021 – EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

BAVENCIO® (AVELUMAB)

https://www.bavencio.com/patients-and-caregivers

INDICATIONS

BAVENCIO is a prescription medicine used to treat:

A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread
A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working

These indications are approved under accelerated approval based on clinical trials that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials.

It is not known if BAVENCIO is safe and effective in children under the age of 12.

About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications
BAVENCIO® (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients in 50 countries for at least one use.

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

www.emdserono.com.

www.pfizer.com.

Pfizer, Merck KGaA's Bavencio OK'd in Europe in bladder cancer

Jan. 25, 2021 5:06 AM ETPfizer Inc. (PFE)By: Mamta Mayani, SA News Editor

EMD Serono, the Healthcare business sector of (NYSE:PFE) and Merck KGaA (OTCPK:MKGAF) announce that the European Commission (EC) has approved Bavencio (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

https://seekingalpha.com/news/3653757-pfizer-merck-kgaas-bavencio-okd-in-europe-in-bladder-cancer

https://seekingalpha.com/symbol/MKGAF

https://seekingalpha.com/symbol/PFE

INDICATIONS BAVENCIO is a prescription medicine used to treat: A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working These indications are approved under accelerated approval based on clinical trials that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials. It is not known if BAVENCIO is safe and effective in children under the age of 12.

Calquence (acalabrutinib)

Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia

PUBLISHED 25 January 2021

25 January 2021 07:05 GMT

88% of patients on Calquence remained free of disease progression after 12 months vs. 68% for comparators

AstraZeneca’s Calquence (acalabrutinib), a next-generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]).

Calquence (acalabrutinib)

https://www.calquence.com/

What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

It is not known if CALQUENCE is safe and effective in children.

Please see full Prescribing Information, including Patient Information.

In the ASCEND trial, Calquence reduced the risk of disease progression or death by 69% (hazard ratio, 0.31; 95% confidence interval, 0.20-0.49, p<0.0001). These results were published in Journal of Clinical Oncology in 2020.1

Please visit astrazeneca.com

AstraZeneca's Calquence successful in lymphocytic leukaemia study

Jan. 25, 2021 6:41 AM ET AstraZeneca PLC (AZN)

By: Mamta Mayani, SA News Editor2 Comments

AstraZeneca (NASDAQ:AZN) announces positive results from the ELEVATE-RR Phase III trial which showed that Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.

https://seekingalpha.com/news/3653778-astrazenecas-calquence-successful-in-lymphocytic-leukaemia-study

https://seekingalpha.com/symbol/AZN

What is CALQUENCE? CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is not known if CALQUENCE is safe and effective in children. Please see full Prescribing Information, including Patient Information.

SYLVANT® (Siltuximab

EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for SYLVANT® (Siltuximab for Injection) in China

January 25, 2021 at 7:00 AM ESTSYLVANT BLA Acceptance_1.21.21_EN.pdf

SYLVANT® (Siltuximab

https://www.sylvant.com/en-us

What is SYLVANT?

SYLVANT® (siltuximab) is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection. It is not known if SYLVANT is safe and effective in children.

BeiGene/EUSA Pharma's Sylvant application accepted by NMPA of China

Jan. 25, 2021 7:43 AM ET BeiGene, Ltd. (BGNE) By: Vandana Singh, SA News Editor

Under priority review status, National Medical Products Administration (NMPA) of China has accepted EUSA Pharma & BeiGene's (NASDAQ:BGNE) marketing application seeking approval for Sylvant (siltuximab for injection) for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are HIV negative and human herpesvirus-8 (HHV-8) negative.

https://seekingalpha.com/news/3653804-beigeneeusa-pharmas-sylvant-application-accepted-by-nmpa-of-china

https://www.beigene.com/

https://seekingalpha.com/symbol/BGNE

BeiGene
Pipeline

We are advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. We have three internally-developed late-stage assets, five marketed products in China and one marketed product in the U.S.

https://www.beigene.com/science-and-product-portfolio/pipeline

What is SYLVANT? SYLVANT® (siltuximab) is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection. It is not known if SYLVANT is safe and effective in children.

CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version

– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –

– Exelixis prepared to fully support expanded indication immediately –

– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1

CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)

Press Release

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version

– Exelixis prepared to fully support expanded indication immediately –

– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –

“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”

The approval is based on results from CheckMate -9ER, a phase 3 pivotal trial evaluating the combination of CABOMETYX and OPDIVO compared with sunitinib in previously untreated advanced or metastatic RCC. These results were presented during the European Society of Medical Oncology Virtual Congress 2020 in September. The FDA reviewed the application for CABOMETYX and OPDIVO under the Real-Time Oncology Review (RTOR) pilot program and Fast Track designation. The RTOR pilot program, which allows an applicant to pre-submit components of the application to allow the FDA to review clinical trial data before the complete filing is submitted, aims to explore a more efficient review process to ensure safe and effective treatments are available to patients sooner.

“As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that CABOMETYX in combination with OPDIVO is now available for the first-line treatment of patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “This approval is a meaningful milestone for this patient community and speaks to the broad potential of CABOMETYX as we continue to generate important clinical trial results supporting its use in combination with immune checkpoint inhibitors to benefit patients with other difficult-to-treat cancers. We would like to thank the clinical trial participants, the physicians and their staff who participated in the CheckMate -9ER trial and to acknowledge the team at the FDA for their collaboration during the review of our application.”

In CheckMate -9ER, the combination regimen significantly improved overall survival (OS) compared with sunitinib (HR= 0.60, 98.89% CI 0.40-0.89; p=0.001). Median OS has not yet been reached in either treatment arm. Median progression-free survival (PFS) was doubled at 16.6 months for CABOMETYX in combination with OPDIVO compared with 8.3 months for sunitinib (HR 0.51, 95% CI 0.41-0.64; p<0.0001). Objective response rate (ORR) was also doubled: 56% with CABOMETYX in combination with OPDIVO and 27% with sunitinib (p<0.0001). Consistent results for PFS were observed across subgroups of International Metastatic RCC Database Consortium risk status and PD-L1 tumor expression with CABOMETYX in combination with OPDIVO.

CABOMETYX in combination with OPDIVO was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC. The most common adverse reactions reported in at least 20% of patients treated with CABOMETYX in combination with OPDIVO were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection. The discontinuation rate due to all causality adverse events in the CABOMETYX in combination with OPDIVO arm was 20% for either CABOMETYX or OPDIVO (8% for CABOMETYX only, 7% for OPDIVO only and 6% for both CABOMETYX and OPDIVO due to the same adverse event at the same time).

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with OPDIVO (nivolumab). CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

https://www.cabometyx.com/

For more information about Exelixis, please visit www.exelixis.com

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Fri January 22, 2021 1:10 PM| Business Wire|About: EXEL

– Exelixis (EXEL) prepared to fully support expanded indication immediately –

– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL)

https://seekingalpha.com/pr/18161776-exelixis-announces-u-s-fda-approval-of-cabometyx-cabozantinib-in-combination-opdivo-nivolumab

Exelixis' CABOMETYX-OPDIVO combo wins FDA approval for renal cell carcinoma

Jan. 22, 2021 1:25 PM ET Exelixis, Inc. (EXEL)

By: Aakash Babu, SA News Editor9 Comments

Exelixis (EXEL +2.6%) announces that the FDA has approved its CABOMETYX (cabozantinib) drug in combination with Bristol-Myers Squibb's (BMY +1.2%) OPDIVO (nivolumab) for treating patients with advanced renal cell carcinoma (RCC) in the first-line setting.

https://seekingalpha.com/news/3653645-exelixiss-cabometyx-opdivo-combo-wins-fda-approval-for-skin-cancer

https://seekingalpha.com/symbol/EXEL

What is CABOMETYX? CABOMETYX is a prescription medicine used to treat people with: Advanced kidney cancer (renal cell carcinoma) Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib. It is not known if CABOMETYX is safe and effective in children.

LUPKYNIS™ (voclosporin)

FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis

DOWNLOAD AS PDF JANUARY 22, 2021

- LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -

- LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials

- LUPKYNIS is now commercially available in the U.S. -

- Multimedia components are available with this press release (link here) -

- Conference call to be hosted Monday, January 25, 2021, 8:30 a.m. ET -

VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

LUPKYNIS™ (voclosporin)

LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. To learn more visit www.auriniapharma.com.

To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com.

INDICATIONS

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210122005501/en/

https://seekingalpha.com/pr/18162086-fda-approves-aurinia-pharmaceuticals-lupkynis-voclosporin-for-adult-patients-active-lupus

Aurinia gets FDA approval for lupus nephritis therapy

Jan. 22, 2021 11:39 PM ET Aurinia Pharmaceuticals Inc. (AUPH)

By: Dulan Lokuwithana, SA News Editor13 Comments

The FDA has approved LUPKYNISTM (voclosporin) from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) as a treatment for adults with active lupus nephritis (“LN”) in combination with a background immunosuppressive therapy regimen.

https://seekingalpha.com/news/3653727-aurinia-gets-fda-approval-for-lupus-nephritis-therapy

https://seekingalpha.com/symbol/AUPH

For U.S. Audiences Only You can learn more about LUPKYNIS™ by visiting the product website or downloading the full U.S. prescribing information.

NVX-CoV2373

Novavax and Government of Canada Finalize Advance Purchase Agreement for COVID-19 Vaccine

Jan 22, 2021 at 5:22 PM ESTDownload PDFCanadian government commits to purchase 52 million doses with option for additional 24 million of Novavax candidate vaccine, NVX-CoV2373

GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company’s recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

NVX-CoV2373

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

For more information, visit www.novavax.com

https://www.novavax.com/our-pipeline#nvx-cov2373

Government of Canada fnalizes advance purchase agreement for COVID-19 Vaccine with Novavax

Jan. 22, 2021 5:30 PM ETNovavax, Inc. (NVAX)By: Manshi Mamtora, CFA6 Comments

https://seekingalpha.com/news/3653710-government-of-canada-fnalizes-advance-purchase-agreement-for-covid-19-vaccine-with-novavax

https://seekingalpha.com/symbol/NVAX

NVX-CoV2373

CABENUVA (rilpivirine and cabotegravir)

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIVCABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression

TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI).

CABENUVA (rilpivirine and cabotegravir)

About CABENUVA (rilpivirine and cabotegravir)
CABENUVA is approved as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA is administered by a healthcare provider once-monthly as two individual intramuscular injections in the buttocks.

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

About EDURANT® (rilpivirine)
EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

Limitations of Use:

More EDURANT®-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT®-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL

EDURANT® is also indicated in combination with VOCABRIA (oral cabotegravir) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as:

Oral lead-in to assess the tolerability of rilpivirine prior to administration of rilpivirine extended-release injectable suspension, a component of CABENUVA (cabotegravir, rilpivirine) extended-release injectable suspensions
Oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions

Janssen is the marketing authorization holder for EDURANT® in the U.S.

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies.

Please see full Prescribing Information.

EDURANT® Important Safety Information

https://www.edurant.com/

Please refer to the EDURANT® Prescribing Information for additional information.

Learn more at www.janssen.com

To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Thu January 21, 2021 10:57 PM|PR Newswire PR Newswire

TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://seekingalpha.com/pr/18161129-janssen-announces-u-s-fda-approval-of-cabenuva-rilpivirine-and-cabotegravir-first-long-acting

FDA OK's Janssen's HIV drug combo Cabenuva

Jan. 21, 2021 11:51 PM ET Johnson & Johnson (JNJ) By: Mamta Mayani, SA News Editor1 Comment

https://seekingalpha.com/news/3653426-fda-oks-janssens-hiv-drug-combo-cabenuva

https://seekingalpha.com/symbol/JNJ

About EDURANT® EDURANT® (rilpivirine) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older and who weigh at least 77 lbs (35 kg): Have never taken HIV medicines before, and Have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL EDURANT® is not recommended for patients less than 12 years of age or who weigh less than 77 lbs (35 kg)

Jyseleca® ▼(filgotinib)

NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis

January 21, 2021 02:08 ET | Source: Galapagos NVmultilang-release

NOT FOR DISTRIBUTION IN THE UNITED KINGDOM

NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3

Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (Euronext & Nasdaq: GLPG) today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA®▼ (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier - potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 RA is a degenerative auto-immune disease that can cause life-threatening complications.4 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England.5,6

https://www.glpg.com/press-releases

Jyseleca® ▼(filgotinib)

About filgotinib7
Filgotinib is a Janus-kinase (JAK) inhibitor and works by preferentially targeting JAK1, part of a specific pathway involved in inflammation – an immune response of the body that causes symptoms of RA. In clinical studies, filgotinib has been shown to significantly improve the chance of disease remission (a DAS28-CRP score of <2.6, indicating few or no symptoms).7 In the FINCH 1 study of 1,755 patients with RA who had an inadequate response to methotrexate, 34% of patients given filgotinib 200mg + methotrexate (n=475) achieved disease remission after just 12 weeks, compared to 9% of a group given placebo (n=475). After 24 weeks, 48% of patients in this group had achieved remission vs. 16% of those on placebo and these response levels were sustained through 52 weeks. In many cases, responses were seen within two weeks (measured using an ACR20 score).

Data supporting filgotinib include more than 3,800 patients treated across the Phase 3 FINCH and Phase 2 DARWIN programmes. In the FINCH studies, filgotinib consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or methotrexate.

Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were uncommon. The frequency of serious infections in the filgotinib 200mg group was 1.0 percent compared with 0.6 percent in the placebo group. In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with filgotinib were comparable to placebo. The rates of serious infections remained stable with long-term exposure.

More information at www.glpg.com.

Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis

Thu January 21, 2021 2:08 AM|GlobeNewswire|About: GLPG

NOT FOR DISTRIBUTION IN THE UNITED KINGDOM

NICE guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1
More than 400,000 people across the UK live with RA2 and around 70% have moderate or severe disease3

Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (GLPGF) (Euronext & Nasdaq: GLPG)

https://seekingalpha.com/pr/18159322-nice-recommends-jyseleca-filgotinib-on-nhs-in-landmark-decision-for-rheumatoid-arthritis

Galapagos' filgotinib recommended for use in England for rheumatoid arthritis

Jan. 21, 2021 6:43 AM ET Galapagos NV (GLPG) By: Mamta Mayani, SA News Editor2 Comments

https://seekingalpha.com/news/3653002-galapagos-filgotinib-recommended-for-use-in-england-for-rheumatoid-arthritis

https://seekingalpha.com/symbol/GLPG

https://seekingalpha.com/symbol/GILD

Clinical Pipeline

VASCEPA® (icosapent ethyl) Capsules

ICOSAPENT ETHYL INCLUDED IN THE CHINESE SOCIETY OF CARDIOLOGY (CSC) UPDATED GUIDELINES FOR PRIMARY PREVENTION OF CARDIOVASCULAR DISEASES

PDF Version Jan 21, 2021

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include “icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT®) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population.”1

VASCEPA® (icosapent ethyl) Capsules

About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times. VASCEPA is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the U.S. FDA in December 2019.

Indications and Limitation of Use
VASCEPA is indicated:

As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

https://www.vascepa.com/

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.2 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.3 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.4 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.

Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascular Diseases

Thu January 21, 2021 4:30 PM|GlobeNewswire |About: AMRN

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://seekingalpha.com/pr/18160910-icosapent-ethyl-included-in-chinese-society-of-cardiology-csc-updated-guidelines-for-primary

Chinese Society of Cardiology recommends use of Amarin's icosapent ethyl in cardiovascular diseases

Jan. 22, 2021 7:01 AM ET

Amarin Corporation plc (AMRN)

By: Mamta Mayani, SA News Editor4 Comments

The Chinese Society of Cardiology has included Amarin's (NASDAQ:AMRN) icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021.

https://seekingalpha.com/news/3653472-chinese-society-of-cardiology-recommends-use-of-amarins-icosapent-ethyl-in-cardiovascular-diseases

Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction

January 29, 2021 12:52 ET | Source: Amarin Corporation plc

Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study

European Commission decision on the Marketing Authorisation Application expected in April 2021

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that in response to Amarin’s Marketing Authorisation Application submission, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending that a marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VASCEPA®.

https://www.globenewswire.com/news-release/2021/01/29/2166794/0/en/Amarin-Receives-Positive-CHMP-Opinion-for-Icosapent-Ethyl-for-Cardiovascular-Risk-Reduction.html

https://seekingalpha.com/symbol/AMRN

INDICATIONS WHAT IS VASCEPA? VASCEPA is a prescription medicine used: along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease. along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if VASCEPA is safe and effective in children.

ORLADEYO™ (berotralstat)

BioCryst Announces Approval of ORLADEYO™ (berotralstat) in Japan for the Prophylactic Treatment of Hereditary Angioedema

PDF Version

ORLADEYO™ (berotralstat) 150 mg, for Japan

RESEARCH TRIANGLE PARK, N.C., Jan. 22, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for oral, once-daily ORLADEYO™ (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

ORLADEYO™ (berotralstat)

About ORLADEYO™ (berotralstat)

U.S. Indication and Important Safety Information

INDICATION
ORLADEYOTM (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

ORLADEYO is the first and only prophylactic HAE medication approved in Japan. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

ORLADEYO will be commercialized in Japan by BioCryst’s partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization.

Torii will launch ORLADEYO in Japan following the successful completion of BioCryst’s pricing negotiations with the Japanese National Health Insurance System (NHI).

Please see full Prescribing Information.

https://orladeyo.com/

For more information, please visit the company’s website at www.biocryst.com.

For more information, please visit www.orphanpacific.com/en/.

https://www.globenewswire.com/NewsRoom/AttachmentNg/3c7764e3-37b3-428c-8dbf-b81655b08a6c

BioCryst Announces Approval of ORLADEYO™ (berotralstat) in Japan for the Prophylactic Treatment of Hereditary Angioedema

Fri January 22, 2021 7:00 AM |GlobeNewswire|About: BCRX

RESEARCH TRIANGLE PARK, N.C., Jan. 22, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) (Nasdaq: BCRX)

https://seekingalpha.com/pr/18161269-biocryst-announces-approval-of-orladeyo-berotralstat-in-japan-for-prophylactic-treatment-of

BioCryst's hereditary angioedema med OK'd in Japan

Jan. 22, 2021 7:10 AM ET BioCryst Pharmaceuticals, Inc. (BCRX)

By: Vandana Singh, SA News Editor3 Comments

BioCryst Pharmaceuticals' (NASDAQ:BCRX) gains 7% in premarket, as Ministry of Health, Labor and Welfare in Japan has approved oral, once-daily Orladeyo (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema adults and pediatric patients 12 years and older.

https://seekingalpha.com/news/3653476-biocrysts-hereditary-angioedema-med-okd-in-japan

https://seekingalpha.com/symbol/BCRX

Retifanlimab (formerly INCMGA0012)

Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

January 21, 2021 DownloadPDF Format (opens in new window)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

Retifanlimab (formerly INCMGA0012)

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005917/en/

For additional information on Incyte, please visit Incyte.com

Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Thu January 21, 2021 4:30 PM| Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

https://seekingalpha.com/pr/18160916-incyte-announces-acceptance-and-priority-review-of-bla-for-retifanlimab-potential-treatment

Incyte's retifanlimab wins FDA's Priority Review status

Jan. 21, 2021 4:37 PM ET Incyte Corporation (INCY)

By: Aakash Babu, SA News Editor

https://seekingalpha.com/news/3653339-incytes-retifanlimab-wins-fdas-priority-review-status

https://seekingalpha.com/symbol/INCY

True Human™ COVID-19 Therapy

XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain

Jan 21, 2021Download PDFWith New Infectious Strain Rapidly Spreading, XBiotech Establishes Data Indicating its Candidate True Human™ COVID-19 Therapy may be Effective for Treating New Mutant Strain

AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announces that its COVID-19 candidate True Human™ antibody therapy may also be used for treating the COVID-19 mutant virus that recently emerged in the UK and is now rapidly spreading across the US.

For more information, visit www.xbiotech.com.

True Human™ COVID-19 Therapy

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

http://xbiotech.com/

XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain

Thu January 21, 2021 8:15 AM|GlobeNewswire|About: XBITGlobeNewswire

AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (XBIT)

https://seekingalpha.com/pr/18159820-xbiotech-candidate-true-human-covidminus-19-therapy-found-to-target-highly-infectious

XBiotech says its antibody therapy is effective against new COVID-19 strain

Jan. 21, 2021 10:05 AM ETXBiotech Inc. (XBIT)By: Dulan Lokuwithana, SA News Editor

After an analysis against mutant COVID-19 virus found in the U.K., XBiotech (XBIT +4.6%) says its COVID-19 candidate True Human™ antibody therapy may also be used for treating the new coronavirus strain.

https://seekingalpha.com/news/3653140-xbiotech-says-its-antibody-therapy-is-effective-against-new-covid-19-strain

https://seekingalpha.com/symbol/XBIT

SARS-COV-2 / COVID-19 XBiotech currently has several COVID-19 programs in place. XBiotech is developing a True Human™ antibody therapy against SARS-CoV2, the virus that causes COVID-19, by identifying and cloning antibodies against the virus from COVID-19-recovered patients. By doing this, XBiotech is essentially harnessing the body’s natural immunity to the virus to be used as a treatment that could potentially be safe and effective—even at treating reinfection by the virus.

biotecMAX™ January 2021 Insight

Bamlanivimab (LY-CoV555)

Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents

January 21, 2021 Download PDF

INDIANAPOLIS, Jan. 21, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) – enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.

Bamlanivimab (LY-CoV555)

neutralizing antibody bamlanivimab (LY-CoV555)

Bamlanivimab is authorized for emergency use by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients. For more information about the use of bamlanivimab, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit covid.infusioncenter.org or the HHS Therapeutics Distribution locator to find a potential treatment location near you. Visit combatcovid.hhs.gov to find out more about antibody therapy.

Important Information about bamlanivimab
Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

To learn more about Lilly, please visit us at www.lilly.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented-covid-19-at-nursing-homes-in-the-blaze-2-trial-reducing-risk-by-up-to-80-percent-for-residents-301212159.html

Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents

Thu January 21, 2021 8:00 AM|PR Newswire|About: LLY

INDIANAPOLIS, Jan. 21, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555)

https://seekingalpha.com/pr/18159669-lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented-covidminus-19-nursing-homes-in

Eli Lilly's bamlanivimab effective in reducing COVID-19 risk in late-stage trial

Jan. 21, 2021 8:30 AM ETEli Lilly and Company (LLY)By: Jonathan M Block, SA News Editor

Eli Lilly (NYSE:LLY) reports that bamlanivimab was effective in reducing COVID-19 in residents and staff at long-term care facilities. https://seekingalpha.com/news/3653068-

https://seekingalpha.com/symbol/LLY

Prognosis Eli Lilly Antibody Cuts Covid-19 Risk Up to 80% in Nursing Home Study By Riley Griffin January 21, 2021, 8:00 AM EST

Esbriet (pirfenidone)

Wednesday, Jan 20, 2021

FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease

South San Francisco, CA -- January 20, 2021 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.

Esbriet (pirfenidone)

About Esbriet
Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF) and is available in more than 60 countries worldwide. Esbriet was FDA-approved for use in people with IPF in October 2014.

Esbriet U.S. Indication
Esbriet is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

It is not known if Esbriet is safe and effective in children.

Please see full Prescribing Information, including Patient Information, for additional important safety information at http://www.esbriet.com.

https://www.esbriet.com/

Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

https://www.gene.com/

For additional information about the company, please visit http://www.gene.com.

FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease

Thu January 21, 2021 1:00 AM|Business Wire|About: RHHBY

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://seekingalpha.com/pr/18159301-fda-grants-priority-review-to-genentech-s-esbriet-pirfenidone-for-unclassifiable-interstitial

Genentech's Esbriet nabs accelerated review in U.S. for interstitial lung disease

Jan. 21, 2021 2:16 AM ET Roche Holding AG (RHHBY)

By: Mamta Mayani, SA News Editor

Under Priority Review status, the FDA accepts Roche (OTCQX:RHHBY) unit, Genentech's supplemental New Drug Application (sNDA) for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).

https://seekingalpha.com/news/3652972-genentechs-esbriet-nabs-accelerated-review-in-us-for-interstitial-lung-disease

https://seekingalpha.com/symbol/RHHBY

Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

VERQUVO® (vericiguat)

Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat)

January 20, 2021 6:45 am EST

VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45%

VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat Heart Failure

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved VERQUVO, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval of VERQUVO by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. VERQUVO (vericiguat) 2.5 mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG.

VERQUVO® (vericiguat)

About VERQUVO® (vericiguat) tablets for once daily oral use (2.5 mg, 5 mg and 10 mg)
Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

About the Worldwide Collaboration Between Bayer and Merck
Since October 2014, Bayer and Merck (known as MSD outside of the United States and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

For more information, visit www.merck.com

Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.

Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat)

Wed January 20, 2021 6:45 AM|Business Wire|About: MRK

https://seekingalpha.com/pr/18158044-merck-announces-u-s-fda-approval-of-verquvo-vericiguat

Merck/Bayer's Verquvo OK'd in U.S. for chronic heart failure

Jan. 20, 2021 7:14 AM ET Merck & Co., Inc. (MRK)

By: Mamta Mayani, SA News Editor

The FDA approves Merck's (NYSE:MRK) Verquvo, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure following hospitalization or need for outpatient intravenous diuretics in adults with chronic heart failure and ejection fraction less than 45%.

https://seekingalpha.com/news/3652583-merckbayers-verquvo-okd-in-us-for-chronic-heart-failure

https://seekingalpha.com/symbol/BAYRY

https://seekingalpha.com/symbol/MRK

Can Merck and Bayer's newly approved Verquvo stand out in an ever-more-competitive heart failure field? by Angus Liu | Jan 20, 2021 8:10am

Opdivo® (nivolumab) Combined with Chemotherapy

U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

01/20/2021CATEGORY:

Corporate/Financial News

U.S. Food and Drug Administration assigned a target action date of May 25, 2021

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.

Opdivo® (nivolumab) Combined with Chemotherapy

About Opdivo ®

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

https://www.opdivo.com/

U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer

Wed January 20, 2021 6:59 AM|Business Wire|About: BMY

U.S. Food and Drug Administration assigned a target action date of May 20, 2021

Application based on Phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival versus placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery

Opdivo demonstrated a manageable safety profile consistent with prior studies

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://seekingalpha.com/pr/18158055-u-s-food-and-drug-administration-accepts-for-priority-review-application-for-opdivo-nivolumab

https://seekingalpha.com/symbol/BMY

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer BACK ADVANCED LUNG CANCER NON-SMALL CELL LUNG CANCER OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1 OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer OPDIVO for people who have had prior treatments for non-small cell lung cancer SMALL CELL LUNG CANCER OPDIVO for people who have had prior treatments for small cell lung cancer Choose your condition: Advanced Lung Cancer Advanced Kidney Cancer Advanced Liver Cancer Colorectal Cancer (MSI-H/dMMR) Advanced Esophageal Squamous Cell Cancer Melanoma Head and Neck Squamous Cell Cancer Advanced Bladder Cancer Classical Hodgkin Lymphoma Malignant Pleural Mesothelioma

Omnipod DASH® System

Jan 18, 2021

Insulet’s Omnipod DASH® System Now Available in Canada

ACTON, Mass.--(BUSINESS WIRE)--Jan. 18, 2021-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced the launch of the Omnipod DASH® Insulin Management System (Omnipod DASH System) in Canada.

Omnipod DASH® System

The Omnipod DASH System combines a tubeless, wearable, waterproof1 Pod with an easy-to-use, touchscreen PDM. The handheld, smartphone-like PDM features an intuitive interface that allows customers to wirelessly control the Pod to deliver customizable basal rates and bolus amounts. The Pod provides up to 72 hours2 of continuous insulin therapy and allows individuals to simplify life with no more daily injections.

“The Omnipod System has been a vital part of my diabetes management since 2013 and I am excited that the Omnipod DASH is coming to Canada,” said Esther Funk, a Registered Nurse and Certified Pump Trainer living with Type 1 diabetes. “The touchscreen design makes it simple and easy to operate. Thank you Insulet for continuing to provide new and innovative options for diabetes management.”

For more information visit please visit www.omnipod.com.

About the Omnipod DASH® System:

The Omnipod DASH Insulin Management System is the first and only tubeless device that can provide three days of non-stop insulin delivery. Its unique design consists of just two parts; a lightweight, tubeless, waterproof, wearable Pod controlled by a smartphone touch-screen Bluetooth® enabled controller, minimizing the number of components to carry. The Omnipod DASH System offers simple, smart, discreet insulin control for people diagnosed with Type 1 or insulin-requiring Type 2 diabetes. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210118005010/en/

For more information, please visit: www.insulet.com and www.omnipod.com.

https://seekingalpha.com/pr/18154831-insulet-s-omnipod-dash-system-now-available-in-canada

Insulet's insulin management system launched in Canada

Jan. 19, 2021 2:50 PM ET Insulet Corporation (PODD) By: Vandana Singh, SA News Editor

Insulet (PODD +1.5%) has launched its Omnipod DASH Insulin Management System (Omnipod DASH System) in Canada.

https://seekingalpha.com/news/3652398-insulets-insulin-management-system-launched-in-canada

https://www.insulet.com/

https://seekingalpha.com/symbol/PODD

Omnipod DASH® Insulin Management System: Prescribe a system that simplifies diabetes care from prescription through ongoing care.

https://www.omnipod.com/healthcareproviders/about-omnipod/DASH

Meet the Omnipod DASH® Insulin Management System A tubeless, wireless insulin management system that provides continuous insulin delivery for 3 days (up to 72 hours). Get it all through the pharmacy, with no commitment. Even the Personal Diabetes Manager (PDM) comes at no up-front cost to you†.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Jan 15, 2021 at 8:18 PM CET

Company Announcement

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA (AMY3001) study
Genmab to receive USD 30 million milestone payment on first commercial sale

Copenhagen, Denmark; January 15, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

Full prescribing information will be available at www.DARZALEX.com.

About DARZALEX®(daratumumab)
DARZALEX® (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

For more information, please visit Genmab.com.

Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Fri January 15, 2021 2:17 PM|GlobeNewswire|About: GMAB

Company Announcement

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis
Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA (AMY3001) study
Genmab (GNMSF) to receive USD 30 million milestone payment on first commercial sale

Copenhagen, Denmark; January 15, 2021 – Genmab A/S (Nasdaq: GMAB)

https://seekingalpha.com/pr/18154172-genmab-announces-janssen-granted-u-s-fda-approval-for-darzalex-faspro-daratumumab-and

Genmab's therapy for AL amyloidosis receives FDA approval

Jan. 15, 2021 3:01 PM ET Genmab A/S (GMAB)

By: Dulan Lokuwithana, SA News Editor

Genmab A/S (NASDAQ:GMAB) has announced that the FDA has approved DARZALEX FASPRO® to treat newly diagnosed Light-chain (“AL”) amyloidosis, a rare disease affecting an estimated ~3,000 to 4,000 individuals in the U.S. annually.

https://seekingalpha.com/news/3651950-genmabs-therapy-for-al-amyloidosis-receives-fda-approval

https://seekingalpha.com/symbol/GMAB

https://seekingalpha.com/symbol/JNJ

What is DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)? DARZALEX FASPRO™ is a prescription medicine used to treat adult patients with multiple myeloma: in combination with the medicines bortezomib, melphalan and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma

XALKORI® (CRIZOTINIB)

PFIZER’S XALKORI® (CRIZOTINIB) APPROVED BY FDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS

Thursday, January 14, 2021 - 04:30pm

XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.1,2,3 Approximately 90% of ALCL cases in young people are ALK-positive.4,5,6

XALKORI® (CRIZOTINIB)

About XALKORI® (crizotinib)

XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. In addition to the United States, XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 70 countries.

XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

The full prescribing information for XALKORI can be found here.

IMPORTANT XALKORI® (crizotinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

to learn more, please visit us on www.Pfizer.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210114006005/en/

https://www.pfizer.com/

Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults

Thu January 14, 2021 4:30 PM|Business Wire|About: PFE

XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

https://seekingalpha.com/pr/18153110-pfizer-s-xalkori-crizotinib-approved-fda-for-alk-positive-anaplastic-large-cell-lymphoma-in

Pfizer’s XALKORI wins FDA's expanded approval for a form of lymphoma

Jan. 14, 2021 4:44 PM ETPfizer Inc. (PFE)By: Aakash Babu, SA News Editor3 Comments

The FDA has approved Pfizer's (NYSE:PFE) supplemental New Drug Application ((sNDA)) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase positive.

https://seekingalpha.com/news/3651642-pfizer-s-xalkori-wins-fdas-expanded-approval-for-form-of-lymphoma

https://seekingalpha.com/symbol/PFE

XALKORI® (CRIZOTINIB)

https://www.xalkori.com/

Indications

XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.

Indications XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.

ENHERTU® (trastuzumab deruxtecan

ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer

Download the PDF version of Article

January 15, 2021

First HER2 directed medicine approved for patients with gastric cancer in a decade

Tokyo, Munich and Basking Ridge, NJ – (January 15, 2021) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

This press release features multimedia. View the full release here.

ENHERTU® (trastuzumab deruxtecan

About ENHERTU

ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S.) is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. ENHERTU is comprised of a humanized anti-HER2 IgG1 monoclonal antibody with the same amino acid sequence as trastuzumab attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.

ENHERTU (5.4 mg/kg) is approved in the U.S. under accelerated approval, and in Japan, under the conditional early approval system, for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial, and received a CHMP positive opinion in December 2020 as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. ENHERTU (6.4 mg/kg) is also approved in the U.S. and Japan for the treatment of previously treated patients with HER2 positive metastatic gastric cancer based on the DESTINY-Gastric01 trial.

https://www.enhertu.com/en/

What is ENHERTU?

ENHERTU (en-HER-too) is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments.

ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.

Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

https://www.enhertu.com/en/

AstraZeneca's antibody drug conjugate Enhertu wins expanded approval from the FDA

Jan. 15, 2021 4:43 PM ET Daiichi Sankyo Company, Limited (DSKYF) By: Aakash Babu, SA News Editor2 Comments

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) antibody drug conjugate Enhertu wins approval from the U.S. FDA for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

https://seekingalpha.com/news/3651990-astrazenecas-antibody-drug-conjugate-enhertu-wins-expanded-approval-from-fda

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=761139&event=overview.process&source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer

PUBLISHED20 January 2021

20 January 2021 07:00 GMT

Approval based on DESTINY-Breast01 Phase II trial which showed clinically meaningful and durable responses in patients with previously treated disease

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/enhertu-approved-in-the-eu-for-breast-cancer.html?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

AstraZeneca's Enhertu wins conditional approval in U.K. for breast cancer

Feb. 16, 2021 3:16 AM ET AstraZeneca PLC (AZN)

By: Mamta Mayani, SA News Editor1 Comment

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been granted conditional authorisation in U.K. as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

https://seekingalpha.com/news/3662020-astrazenecas-enhertu-wins-conditional-approval-in-uk-for-breast-cancer

https://seekingalpha.com/symbol/AZN

What is ENHERTU? ENHERTU (en-HER-too) is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments. ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.

Imfinzi (durvalumab)

15 January 2021 07:00 GMT

Imfinzi approved in the EU for less-frequent, fixed-
dose use in unresectable non-small cell lung cancer

New option extends dosing from two to four weeks,
reducing medical visits and improving patient convenience

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

AstraZeneca’s Imfinzi additional dosing option OK'd in the EU/UK

Jan. 15, 2021 7:27 AM ETAstraZeneca PLC (AZN)By: Vandana Singh, SA News Editor

AstraZeneca's (NASDAQ:AZN) Imfinzi (durvalumab) has been approved in the EU and the U.K. for an additional dosing option. New dosing is a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based chemoradiation therapy.

https://seekingalpha.com/news/3651756-astrazeneca-s-imfinzi-additional-dosing-option-okd-in-eu-uk

https://seekingalpha.com/symbol/AZN

Imfinzi (durvalumab)

https://www.imfinzi.com/

IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).

It is not known if IMFINZI is safe and effective in children.

. Please visit astrazeneca.com

IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC). It is not known if IMFINZI is safe and effective in children.

IMBRUVICA®* (ibrutinib)

**Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)**

Wed January 13, 2021 7:30 AM| Canada Newswire| About: JNJ

Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients treated with FCR, a chemoimmunotherapy regimen

TORONTO, Jan. 13, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).i Today's milestone marks the tenth Health Canada approval for IMBRUVICA® across five disease areas and is the fifth approval for IMBRUVICA® in CLL.ii

**IMBRUVICA®* (ibrutinib)**

About IMBRUVICA®
IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.xv

IMBRUVICA® was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL),xvi including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion.xvii It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL.xviii It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL.xix

For adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA® is indicated as a single agent or in combination with rituximab.xx Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).xxi

IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA® in Canada.

https://imbruvica.com/

Learn more at www.janssen.com/canada.

Johnson & Johnson's Imbruvica combo OK'd in Canada in CLL setting

Jan. 13, 2021 8:25 AM ET Johnson & Johnson (JNJ)By: Aakash Babu, SA News Editor

Health Canada has approved Johnson & Johnson's (NYSE:JNJ)

https://seekingalpha.com/news/3651021-johnson-johnsons-imbruvica-combo-okd-in-canada-in-cll-setting

https://www.janssen.com/canada/

https://seekingalpha.com/symbol/JNJ

https://www.jnj.com/

https://imbruvica.com/

What is IMBRUVICA® (ibrutinib)? IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with: Mantle cell lymphoma (MCL) who have received at least one prior treatment Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion Waldenström’s macroglobulinemia (WM) Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy It is not known if IMBRUVICA® is safe and effective in children.

Vicineum™

PRESS RELEASE

Sesen Bio and Qilu Pharmaceutical Announce IND Application for Vicineum™ Accepted for Review by the National Medical Products Administration in China

January 13, 2021 at 8:00 AM ESTPDF Version

Clinical trial expected to be initiated shortly after NMPA approval of the IND

Sesen Bio to receive $3M milestone payment upon IND approval

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported that the Investigational New Drug (IND) application submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) by the Company’s partner in China, Qilu Pharmaceutical, was accepted for review. If the IND is approved, Qilu will be authorized to conduct the proposed clinical trial to assess the efficacy and safety of VicineumTM in patients with non-muscle invasive bladder cancer (NMIBC) in Greater China. The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial in the United States (US) for the treatment of high-risk, bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. In December 2020, the Company completed the Biologics License Application (BLA) submission for Vicineum to the FDA.

Vicineum™

About Vicineum™

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In December 2020, Sesen Bio completed the BLA submission for Vicineum to the FDA. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

For more information, please visit the company’s website at www.sesenbio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210113005062/en/

Sesen Bio and Qilu Pharmaceutical Announce IND Application for Vicineum™ Accepted for Review by the National Medical Products Administration in China

Wed January 13, 2021 8:00 AM|Business Wire|About: SESN

Clinical trial expected to be initiated shortly after NMPA approval of the IND

Sesen Bio (SESN) to receive $3M milestone payment upon IND approval

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio

https://seekingalpha.com/pr/18150025-sesen-bio-and-qilu-pharmaceutical-announce-ind-application-for-vicineum-accepted-for-review

Sesen Bio/Qilu Pharma's Vicineum IND application accepted for review in China

Jan. 13, 2021 10:53 AM ETSesen Bio, Inc. (SESN)By: Vandana Singh, SA News Editor

National Medical Products Administration in China has accepted for review the Investigational New Drug (IND) submitted by Sesen Bio's (SESN -4.7%) partner Qilu Pharmaceutical, to start proposed clinical trial to evaluate Vicineum in Greater China, in patients with non-muscle invasive bladder cancer (NMIBC).

https://seekingalpha.com/news/3651136-sesen-bio-qilu-pharmas-vicineum-ind-application-accepted-for-review-in-china

https://seekingalpha.com/symbol/SESN

http://en.qilu-pharma.com/

OUR PROGRAMS we are developing fusion protein therapeutics for the treatment of cancer. Our fusion protein approach tethers a tumor-targeting antibody fragment to a protein cytotoxic payload to form a single protein molecule designed to selectively and broadly kill cancer cells while minimizing toxicity to healthy cells and to activate the body’s innate immune response system.

tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin

China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

January 13, 2021 at 11:00 PM EST

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 13, 2021-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE®) and carboplatin

results of the interim analysis

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.v Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company.

https://www.abraxane.com/

ABRAXANE is a prescription medicine used to treat

China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

Wed January 13, 2021 11:00 PM|Business Wire|About: BGNE

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (BGNE)

https://seekingalpha.com/pr/18151332-china-national-medical-products-administration-approves-tislelizumab-in-combination

BeiGene's tislelizumab + chemotherapy OK'd in China for lung cancer

Jan. 13, 2021 11:33 PM ET BeiGene, Ltd. (BGNE)By: Mamta Mayani, SA News Editor

The China National Medical Products Administration (NMPA) has approved BeiGene's (NASDAQ:BGNE) tislelizumab for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC).

https://seekingalpha.com/news/3651335-beigenes-tislelizumab-chemotherapy-okd-in-china-for-lung-cancer

https://www.beigene.com/?loc=US

https://seekingalpha.com/symbol/BGNE

https://seekingalpha.com/symbol/BMY

BeiGene Pipeline We are advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. We have three internally-developed late-stage assets, five marketed products in China and one marketed product in the U.S.

biotecMAX™ January 2021 Insight

TYVYT® (sintilimab injection)

Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab as Second-Line Therapy for Squamous Non-Small Cell Lung Cancer

NEWS PROVIDED BY Innovent Biologics Jan 12, 2021, 00:00 ET

SAN FRANCISCO and SUZHOU, China, Jan. 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) as second-line therapy for squamous non-small cell lung cancer (sqNSCLC). The application is the third sNDA for TYVYT® (sintilimab injection) in NSCLC.

TYVYT® (sintilimab injection)

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Eli Lilly and Company, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

In April 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT® in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study. In January 2021, the NMPA accepted the sNDA for TYVYT® as second-line therapy for sqNSCLC.

TYVYT® (sintilimab injection)

http://innoventbio.com/en/#/product/products

For more information, please visit: www.innoventbio.com.

http://innoventbio.com/en/#/

To learn more about Lilly, please visit us at www.lilly.com and lilly.com/newsroom.

Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab as Second-Line Therapy for Squamous Non-Small Cell Lung Cancer

Tue January 12, 2021 12:00 AM|PR Newswire|About: IVBIY, LLY

SAN FRANCISCO and SUZHOU, China, Jan. 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent", HKEX: 01801)

https://seekingalpha.com/pr/18147251-innovent-announces-nmpa-acceptance-of-supplemental-new-drug-application-for-sintilimab-second

https://seekingalpha.com/symbol/IVBIY

INNOVENT BIOLOGICS, INC. (1801)

https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=1801&sc_lang=en

https://seekingalpha.com/symbol/LLY

PRODUCT CENTER Innovent has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 4 products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection) officially approved for marketing in China, 4 assets in Phase III or pivotal clinical trials, additional 15 molecules in to clinical trials. TYVYT® was included in the National Reimbursement Drug List (NRDL) in 2019 as the only PD-1 in that year and was also the first PD-1 inhibitor included in NRDL historically.

ONUREG® (azacitidine tablets)

Health Canada Approves ONUREG® (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia

Tue January 12, 2021 7:00 AM|Canada Newswire

ONUREG® has shown clinically meaningful increase in overall survival for patients

MONTREAL, Jan. 12, 2021 /CNW/ - Bristol Myers Squibb Canada (BMS)

ONUREG® (azacitidine tablets)

ONUREG® is a nucleoside metabolic inhibitor that is taken orally and works by preventing cancer cells from growing. ONUREG® becomes incorporated into the building blocks of cells (deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)), which interferes with the production of new DNA and RNA. This is thought to kill cancerous cells in leukemia.10

"The approval of ONUREG® is an extension of our ongoing commitment to Canadians living with blood cancer," said Al Reba, General Manager, Bristol Myers Squibb Canada. "We are proud that this therapy will help to fill a significant need for Canadians living in remission from AML and hope that it will have a positive impact on their everyday life."

For more information about Bristol Myers Squibb global operations, visit www.bms.com

For more information, please visit www.bms.com/ca.

https://seekingalpha.com/symbol/BMY

https://www.onureg.com/

What is ONUREG®? ONUREG® is a prescription medicine used for continued treatment of adults with acute myeloid leukemia (AML) who had a first complete remission (CR) following intensive induction chemotherapy with or without recovery of your blood cell counts, and who are not able to complete intensive curative therapy. It is not known if ONUREG® is safe and effective in children under 18 years of age.

Tafasitamab

MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

January 12, 2021 / 10:00 pm, CET Media Release

MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

PLANEGG/MUNICH, Germany and MONTREAL, Canada - January 12, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ: INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

Tafasitamab

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

More information at www.morphosys.com or www.morphosys-us.com.

For additional information on Incyte, please visit Incyte.com

Incyte and MorphoSys Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

Tue January 12, 2021 4:00 PM|Canada Newswire|About: INCY, MOR

MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (INCY) and MorphoSys AG (MPSYF)

https://seekingalpha.com/pr/18149214-incyte-and-morphosys-announce-acceptance-health-canada-of-new-drug-submission-for-tafasitamab

Incyte/MorphoSys' tafasitamab Canada application accepted for review

Jan. 12, 2021 4:15 PM ETIncyte Corporation (INCY)By: Vandana Singh, SA News Editor

Health Canada has accepted for review Incyte (NASDAQ:INCY) and MorphoSys' (NASDAQ:MOR) marketing application seeking approval for tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

https://seekingalpha.com/news/3650854-incyte-morphosys-tafasitamab-canada-application-accepted-for-review

https://seekingalpha.com/symbol/INCY

https://seekingalpha.com/symbol/MOR

(COVID-19 Vaccine Moderna)

United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna

January 8, 2021 at 7:46 AM EST PDF Version

UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study

UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 8, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210108005274/en/

To learn more, visit www.modernatx.com.

(COVID-19 Vaccine Moderna)

To learn more about Moderna’s work on the COVID-19 Vaccine Moderna, visit www.modernatx.com/COVID19.

Moderna's COVID-19 vaccine wins U.K. regulators nod

Jan. 08, 2021 7:33 AM ETModerna, Inc. (MRNA)By: Mamta Mayani, SA News Editor1 Comment

The U.K.'s Medicines and Healthcare products Regulatory Agency has authorized use of Moderna's (NASDAQ:MRNA) COVID-19 vaccine, the third to be licensed for use in the country.

https://seekingalpha.com/news/3649883-modernas-covidminus-19-vaccine-wins-u-k-regulators-nod

MRNA

Moderna's COVID-19 vaccine wins U.K. regulators nod
Today, 7:33 AM | 1 Comment

Prognosis

U.K. Clears Moderna’s Vaccine to Add Third Covid-19 Shot

By Alex Morales, James Paton, and Suzi Ring January 8, 2021, 6:06 AM EST Updated on January 8, 2021, 8:44 AM EST

Approval comes as pandemic surges anew across Britain
U.K. also adds 10 million more vaccine doses from Moderna

https://www.bloomberg.com/news/articles/2021-01-08/u-k-is-said-to-clear-moderna-vaccine-as-soon-as-friday

https://www.modernatx.com/

https://seekingalpha.com/symbol/MRNA

Moderna COVID-19 Vaccine

https://www.modernatx.com/covid19vaccine-eua/

Moderna COVID-19 Vaccine

V114 =Investigational 15-valent Pneumococcal Conjugate Vaccine PNEUMOVAX 23

U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older

January 12, 2021 6:45 am EST

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

Investigational 15-valent Pneumococcal Conjugate Vaccine

About V114

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults. Merck is also developing V114 for use in children. An overview of the late-stage development program for V114 is available here.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.

Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Please see Prescribing Information for PNEUMOVAX 23
at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf
and Patient Information for PNEUMOVAX 23
at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.

PNEUMOVAX 23 is a vaccine that is given as a shot. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus").

PNEUMOVAX 23 is for people 50 years of age and older, and those 2 years of age and older if they have certain medical conditions that put them at increased risk for infection.

https://www.pneumovax23.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210112005398/en/

For more information, visit www.merck.com

U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, for Use in Adults 18 Years of Age and Older

Tue January 12, 2021 6:45 AM| Business Wire|About: MRK

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada

https://seekingalpha.com/pr/18147514-u-s-fda-accepts-for-priority-review-biologics-license-application-for-v114-merck-s

Merck's V114 nabs accelerated review in U.S. for invasive pneumococcal disease in adults

Jan. 12, 2021 6:59 AM ET Merck & Co., Inc. (MRK)By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3650608-mercks-v114-nabs-accelerated-review-in-u-s-for-invasive-pneumococcal-disease-in-adults

https://seekingalpha.com/symbol/MRK

PNEUMOVAX 23 is a vaccine that is given as a shot. It helps protect you from infection by certain germs or bacteria which are called pneumococcus (pronounced "noo-mo-ca-cus"). PNEUMOVAX 23 is for people 50 years of age and older, and those 2 years of age and older if they have certain medical conditions that put them at increased risk for infection.

BAVENCIO® (avelumab)

Health Canada Approves BAVENCIO® for the Maintenance Treatment of Patients with Advanced Bladder Cancer

Mon January 11, 2021 8:00 AM|Canada Newswire|About: MKKGY

BAVENCIO is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma (UC) approved by Health Canada

MISSISSAUGA, ON, Jan. 11, 2021 /CNW/ - EMD Serono Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC announced that Health Canada has approved BAVENCIO® (avelumab) for the maintenance treatment of patients with unresectable locally advanced or metastatic UC whose disease has not progressed following first-line platinum-based chemotherapy.

BAVENCIO® (avelumab)

https://www.bavencio.com/patients-and-caregivers

INDICATIONS

BAVENCIO is a prescription medicine used to treat:

A type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread
A type of cancer in the bladder or urinary tract called urothelial cancer (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains a platinum and it did not work or is no longer working

It is not known if BAVENCIO is safe and effective in children under the age of 12.

About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody and is part of a class of immunotherapy drugs called immune checkpoint inhibitors. BAVENCIO was discovered by Merck KGaA, Darmstadt, Germany and is co-developed and co-commercialized by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC. BAVENCIO is also indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC) and for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.

https://www.emdserono.com/us-en

To learn more about Pfizer Canada, visit pfizer.ca

https://www.pfizer.ca/

https://seekingalpha.com/symbol/MKKGY

https://seekingalpha.com/symbol/PFE

Health Canada OK's Pfizer/Merck KGaA's Bavencio for bladder cancer

Jan. 11, 2021 8:45 AM ET MERCK Kommanditgesellschaft auf Aktien (MKKGY) By: Aakash Babu, SA News Editor1 Comment

Health Canada approves Pfizer (NYSE:PFE) and Merck KGaA (OTCPK:MKKGY) company EMD Serono Canada's Bavencio (avelumab)

https://seekingalpha.com/news/3650247-health-canada-oks-pfizer-merck-kgaas-bavencio-for-bladder-cancer

Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG,

Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial

January 11, 2021Download PDF

INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo in results from Eli Lilly and Company's (NYSE: LLY) Phase 2 TRAILBLAZER-ALZ study. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer's disease. Donanemab also showed consistent improvements in all prespecified secondary endpoints measuring cognition and function compared to placebo, but did not reach nominal statistical significance on every secondary endpoint.

About TRAILBLAZER-ALZ Study
TRAILBLAZER-ALZ (NCT03367403) is a randomized, placebo-controlled, double-blind, multi-center Phase 2 study to assess the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer's disease.

Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG,

The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing randomized, placebo-controlled, double-blind, multi-center Phase 2 study TRAILBLAZER-ALZ 2 (NCT04437511).

To learn more about Lilly, please visit us at lilly.com

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-donanemab-slows-clinical-decline-of-alzheimers-disease-in-positive-phase-2-trial-301204830.html

Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial

Mon January 11, 2021 6:30 AM|PR Newswire| About: LLY

https://seekingalpha.com/pr/18145426-lillys-donanemab-slows-clinical-decline-of-alzheimers-disease-in-positive-phase-2-trial

https://seekingalpha.com/news/3650196-eli-lilly-up-20-after-donanemab-shows-clinical-benefit-in-mid-stage-alzheimers-study

https://seekingalpha.com/symbol/LLY

FACEBOOK TWITTER LINKEDIN PERMALINK BUSINESS HEALTH CARE HEALTH Lilly Alzheimer’s Drug Helped Patients in Small Trial Donanemab slowed cognitive and functional decline of patients with mild Alzheimer’s by 32% compared with placebo By Jonathan D. Rockoff Updated Jan. 11, 2021 10:03 am ET

Jardiance® (empagliflozin)

US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction

January 11, 2021Download PDF

RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020

EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021

Jardiance® (empagliflozin)

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

For more information, please see Prescribing Information and Medication Guide.

For more information, please visit www.boehringer-ingelheim.us

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.

https://www.jardiance.com/

View original content to download multimedia:http://www.prnewswire.com/news-releases/us-fda-accepts-supplemental-new-drug-application-for-jardiance-empagliflozin-for-adults-with-heart-failure-with-reduced-ejection-fraction-301203589.html

https://seekingalpha.com/symbol/LLY

WHAT IS JARDIANCE? JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

valoctocogene roxaparvovec

BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set

- Significantly Reduced Mean Annualized Bleeding Rate by 84% (p-value <0.0001) Demonstrating Superiority to Factor VIII Prophylaxis, and Reduced Mean Annualized Factor VIII Infusion Rate by 99% (p-value <0.0001)

- Mean Factor VIII Expression 42.9 IU/dL at One Year in Full Study Population

- In Subset Dosed More than Two Years Ago, Slower Rate of Decline in Factor VIII Expression Was Observed Compared to Prior Study: Mean ABR in This Population Was 0.9 Over These Two-Plus Years

- BioMarin Plans to Meet with EMA to Discuss Submission of One-Year Data and FDA to Review Two-Year Data Request

- Call and Webinar to be Held Today, Sunday, January 10, 2021 at 7:15 PM Eastern

Jan 10, 2021

SAN RAFAEL, Calif., Jan. 10, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)

valoctocogene roxaparvovec

Valoctocogene roxaparvovec is an investigational AAV5 gene therapy under regulatory review for the treatment of severe hemophilia A.

https://www.biomarin.com/our-treatments/pipeline/valoctocogene-roxaparvovec-for-severe-hemophilia-a/

BioMarin Announces Positive Phase 3 Gene Therapy Trial Results in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set

Sun January 10, 2021 6:44 PM|PR Newswire|About: BMRN

https://seekingalpha.com/pr/18145175-biomarin-announces-positive-phase-3-gene-therapy-trial-results-in-adults-severe-hemophilia

BioMarin's valoctocogene roxaparvovec gene therapy shows positive effect in hemophilia A

Jan. 11, 2021 1:47 AM ET BioMarin Pharmaceutical Inc. (BMRN)By: Mamta Mayani, SA News Editor7 Comments

BioMarin Pharmaceutical (NASDAQ:BMRN)

https://seekingalpha.com/news/3650131-biomarins-valoctocogene-roxaparvovec-gene-therapy-shows-positive-effect-in-hemophilia

https://www.biomarin.com/

For additional information, please visit www.biomarin.com.

https://seekingalpha.com/symbol/BMRN

Valoctocogene roxaparvovec is an investigational AAV5 gene therapy under regulatory review for the treatment of severe hemophilia A. Hemophilia A is a genetic disease caused by the deficiency of clotting factor VIII. It is the most common type of hemophilia and occurs much more frequently in males; incidence is estimated at 1 in 4,000-5,000 male births.

NVX-CoV2373, Novavax’ COVID-19 vaccine candidate

Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine

Jan 07, 2021 at 6:14 PM ESTDownload PDF

Advance Purchase Agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate
Initial doses expected to be delivered as early as mid-2021

GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M™ to enhance the immune response.

NVX-CoV2373, Novavax’ COVID-19 vaccine candidate

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

For more information, visit www.novavax.com

https://www.novavax.com/

Novavax Finalizes Agreement with Commonwealth of Australia for 51 Million Doses of COVID-19 Vaccine

Thu January 7, 2021 6:14 PM|Globe Newswire - Canada|About: NVAX

Advance Purchase Agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate
Initial doses expected to be delivered as early as mid-2021

GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX)

https://seekingalpha.com/pr/18143988-novavax-finalizes-agreement-commonwealth-of-australia-for-51-million-doses-of-covidminus-19

Novavax finalizes deal with Australia for 51M doses of COVID-19 vaccine

Jan. 08, 2021 1:20 AM ET Novavax, Inc. (NVAX) By: Mamta Mayani, SA News Editor3 Comments

https://seekingalpha.com/news/3649829-novavax-finalizes-deal-australia-for-51m-doses-of-covidminus-19-vaccine

https://seekingalpha.com/symbol/NVAX

urrent Protocol for Phase 3 Clinical Trial of NVX-CoV2373 in the U.S. and Mexico

NUBEQA® (darolutamide)

FDA approves Bayer's application to add overall survival benefit to its Nubeqa prescription information

Jan. 08, 2021 12:13 PM ET Bayer Aktiengesellschaft (BAYZF)

By: Aakash Babu, SA News Editor

The FDA has approved Bayer's (OTCPK:BAYZF -2.3%) supplemental marketing application allowing to add overall survival (OS) and other secondary endpoint data from Phase 3 ARAMIS trial to the prescribing information for its cancer treatment Nubeqa (darolutamide).

NUBEQA® (darolutamide)

https://www.nubeqa-us.com/

INDICATION

NUBEQA® (darolutamide) is a prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and is no longer responding to a medical or surgical treatment that lowers testosterone.

It is not known if NUBEQA is safe and effective in women and children.

September 9, 2020Not intended for U.S. and UK Media

New England Journal of Medicine publishes final overall survival data for Nubeqa™ (darolutamide) showing treatment significantly extends life in men with non-metastatic prostate cancer

READ MORE

https://www.bayer.com/en/

https://seekingalpha.com/symbol/BAYZF

INDICATION NUBEQA® (darolutamide) is a prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and is no longer responding to a medical or surgical treatment that lowers testosterone. It is not known if NUBEQA is safe and effective in women and children.

SPINRAZA® (NUSINERSEN)

BIOGEN ANNOUNCES FIRST PATIENT TREATED IN RESPOND STUDY EVALUATING BENEFIT OF SPINRAZA® (NUSINERSEN) IN PATIENTS TREATED WITH ZOLGENSMA® (ONASEMNOGENE ABEPARVOVEC)

January 8, 2021 at 7:30 AM EST

The global Phase 4 RESPOND study will evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma
Clinical and real-world experience have reported that some patients previously treated with Zolgensma have also been treated with SPINRAZA1,2,3,4
Biogen remains committed to exploring the potential of SPINRAZA to optimize outcomes for patients with SMA

CAMBRIDGE, Mass., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the first patient has been treated in the global clinical study, RESPOND. The Phase 4 study will examine the clinical benefit and assess the safety of SPINRAZA® (nusinersen) in infants and children with spinal muscular atrophy (SMA) who still have unmet clinical needs following treatment with gene therapy Zolgensma® (onasemnogene abeparvovec). RESPOND will be conducted at approximately 20 sites worldwide and aims to enroll up to 60 children with SMA.

SPINRAZA® (NUSINERSEN)

More information on the study (NCT04488133) is available at clinicaltrials.gov.

About SPINRAZA® (nusinersen)
SPINRAZA is approved to treat infants, children and adults with spinal muscular atrophy (SMA) and is available in more than 50 countries. As a foundation of care in SMA, more than 11,000 individuals have been treated with SPINRAZA worldwide.6

SPINRAZA is an antisense oligonucleotide (ASO) that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.5 It is administered directly into the central nervous system, where motor neurons reside, to deliver treatment where the disease starts.5

SPINRAZA has demonstrated sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 7 years, combined with unsurpassed real-world experience.7 The SPINRAZA clinical development program encompasses 10 clinical studies, which have included more than 300 individuals across a broad spectrum of patient populations,7 including two randomized controlled studies (ENDEAR and CHERISH). The ongoing SHINE and NURTURE open-label extension studies are evaluating the long-term impact of SPINRAZA. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics. Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website.

https://www.spinraza.com/

We routinely post information that may be important to investors on our website at www.biogen.com.

https://www.biogen.com/en_us/home.html

Biogen moves forward with Spinraza study in SMA patients treated with Zolgensma

Jan. 08, 2021 8:42 AM ET Biogen Inc. (BIIB)By: Gaurav Batavia, SA News Editor

Biogen (NASDAQ:BIIB) has announced that first patient has been treated in Phase 4 (RESPOND) study, assessing benefit and safety of Spinraza (nusinersen) in patients with spinal muscular atrophy (SMA) who have suboptimal clinical response to AveXis' SMA gene therapy Zolgensma (onasemnogene abeparvovec).

https://seekingalpha.com/news/3649898-biogen-moves-forward-spinraza-study-in-sma-patients-treated-zolgensma

https://seekingalpha.com/symbol/BIIB

Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant. Please see full Prescribing Information. This information is not intended to replace discussions with your healthcare provider. INDICATION SPINRAZA® (nusinersen) is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

biotecMAX™ January 2021 Insight

Vutrisiran

Alnylam Reports Positive Topline Results from HELIOS-A Phase 3 Study of Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy

Jan 07, 2021

– Vutrisiran Met Primary and All Secondary Endpoints at 9 Months, with Statistically Significant Improvements in Progression of Neuropathy, Quality of Life (QOL), and Gait Speed, Relative to Placebo –

– Majority of Patients Showed Reversal of Disease Manifestations with Improvements in Neuropathy Impairment and QOL, Relative to Baseline –

– Vutrisiran Showed Improvements in the 9-Month Exploratory Cardiac Endpoint of NT-proBNP, Relative to Placebo –

– In Addition, Vutrisiran Demonstrated Encouraging Safety and Tolerability Profile –

– Alnylam Intends to Present Full 9-Month Results and File New Drug Application (NDA) in Early 2021 –

– Alnylam to Host Conference Call Today at 8:00 am ET –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 7, 2021-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)

Vutrisiran

About Vutrisiran
Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, which encompasses both hereditary (hATTR) and wild-type (wtATTR) amyloidosis. It is designed to target and silence specific messenger RNA, blocking the production of wild-type and variant transthyretin (TTR) protein before it is made. Quarterly administration of vutrisiran may help to reduce deposition and facilitate the clearance of TTR amyloid deposits in tissues and potentially restore function to these tissues. Vutrisiran utilizes Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate delivery platform, designed for increased potency and high metabolic stability that allows for infrequent subcutaneous injections. The safety and efficacy of vutrisiran have not been evaluated by the U.S. Food and Drug Administration, European Medicines Agency or any other health authority.

HELIOS-A (NCT03759379) is a Phase 3 global, randomized, open-label study to evaluate the efficacy and safety of vutrisiran.

For more information about our people, science and pipeline, please visit www.alnylam.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005224/en/

ALNY

Alnylam's vutrisiran successful in late-stage nerve disorder study
Today, 9:25 AM

https://seekingalpha.com/symbol/ALNY

OUR PIPELINE

Alnylam is leading the translation of RNAi (RNA interference) into a whole new class of innovative medicines to potentially address the needs of patients who have limited or inadequate treatment options. Our pipeline of investigational RNAi therapeutics is focused on diseases with high unmet medical need that fall under 4 Strategic Therapeutic Areas (STArs): genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases.

https://www.alnylam.com/alnylam-rnai-pipeline/

OUR PIPELINE Alnylam is leading the translation of RNAi (RNA interference) into a whole new class of innovative medicines to potentially address the needs of patients who have limited or inadequate treatment options. Our pipeline of investigational RNAi therapeutics is focused on diseases with high unmet medical need that fall under 4 Strategic Therapeutic Areas (STArs): genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases.

Somatrogon

US FDA ACCEPTS REGULATORY SUBMISSION FROM PFIZER AND OPKO FOR REVIEW OF SOMATROGON TO TREAT PEDIATRIC PATIENTS WITH GROWTH HORMONE DEFICIENCY

Monday, January 04, 2021 - 07:00amEST

- If approved, somatrogon will serve as a once-weekly treatment option –

NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210104005200/en/

US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Mon January 4, 2021 6:45 AM|Business Wire|About: OPK, PFE

- If approved, somatrogon will serve as a once-weekly treatment option –

NEW YORK & MIAMI--(BUSINESS WIRE)-- Pfizer Inc. (PFE) and OPKO Health Inc. (OPK)

https://seekingalpha.com/pr/18137490-us-fda-accepts-regulatory-submission-from-pfizer-and-opko-for-review-of-somatrogon-to-treat

GENOTROPIN® (somatropin)

About GENOTROPIN® (somatropin)

https://www.genotropin.com/taking-genotropin

About Somatrogon

For more information, visit http://www.OPKO.com.

https://seekingalpha.com/symbol/OPK

to learn more, please visit us on www.pfizer.com

https://seekingalpha.com/symbol/PFE

COVID-19 Vaccine AstraZeneca, formerly AZD1222

HEALTH AND SCIENCE

UK rolls out Oxford-AstraZeneca vaccine as it battles against Covid surge

PUBLISHED MON, JAN 4 20213:01 AM ESTUPDATED MON, JAN 4 20217:22 AM ESTHolly Ellyatt@HOLLYELLYATT

LONDON — The U.K. has started rolling out the coronavirus vaccine developed by AstraZeneca and the University of Oxford, marking another step in its battle against the coronavirus pandemic.

UK begins Oxford-AstraZeneca vaccinations; official more concerned of South Africa variant

CNBC.com staff

https://www.cnbc.com/2021/01/04/covid-live-updates.html

AZN

South Africa to import 1.5M doses of the AstraZeneca vaccine
Today, 7:02 AM

World / Europe

Coronavirus: UK rolls out Oxford-AstraZeneca vaccine but new strains are cause for ‘incredible worry’

The vaccine is seen as a game-changer by many experts because it does not require very cold temperatures for storage
However, scientists are reportedly concerned that vaccines may not work on a new variant of the coronavirus found in South Africa

Agence France-Presse Published: 5:52pm, 4 Jan, 2021

https://www.scmp.com/news/world/europe/article/3116370/coronavirus-uk-rolls-out-oxford-astrazeneca-vaccine-new-strains

U.K. rolls out AstraZeneca-Oxford's COVID-19 vaccine - CNBC

Jan. 04, 2021 4:38 AM ETAstraZeneca PLC (AZN)By: Mamta Mayani, SA News Editor6 Comments

Britain began rolling out the coronavirus vaccine developed by AstraZeneca (NASDAQ:AZN) and the University of Oxford - CNBC.

https://seekingalpha.com/news/3648217-u-k-rolls-out-astrazeneca-oxfords-covidminus-19-vaccine-cnbc

https://www.astrazeneca-us.com/

https://seekingalpha.com/symbol/AZN

COVID-19 Information Hub

Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)

Prognosis

EU Seeks Up to 300 Million More Pfizer-BioNTech Doses

The bloc is pursuing a deal that could double its Pfizer shot supply.

Pfizer COVID-19 Vaccine Production and Distribution Working Well New York, NY, December 17, 2020 – Pfizer Inc. (NYSE: PFE) today released the following statement to address public comments that allege there are issues in the production and distribution of the company’s COVID-19 vaccine:

https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-12/COVID%2019%20Vaccine%20Production%20Distribution%20Statement%20121720.pdf

JANUARY 6, 20219:05 AM

EU may soon approve new use of Pfizer vaccine increasing doses by 20% - source

By Francesco Guarascio BRUSSELS (Reuters) -

https://www.reuters.com/article/health-coronavirus-ema-pfizer/eu-may-soon-approve-extra-doses-from-vials-of-pfizer-covid-19-vaccine-source-idINKBN29B1R6?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

Pfizer/BioNTech to get EU approval for a change for its COVID-19 vaccine use - Reuters

Jan. 06, 2021 12:35 PM ET Pfizer Inc. (PFE)By: Dulan Lokuwithana, SA News Editor7 Comments

https://seekingalpha.com/news/3649328-pfizer-biontech-to-get-eu-approval-for-change-for-covidminus-19-vaccine-use-reuters

Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2)

Please see EUA Fact Sheet at www.cvdvaccine.com.

Prognosis

Pfizer, BioNTech Shot May Defeat New Variants, Study Shows

The research comes as Covid-19 is spreading globally at record daily levels.

Pfizer-BioNTech vaccine protects against mutation found in fast-spreading virus variants, study shows

By Carolyn Y. Johnson

Pfizer vaccine 'works' against key variant mutation, study suggests

By James Gallagher
Health and science correspondent Related Topics Coronavirus pandemic

https://www.bbc.com/news/health-55587320

EU regulators OK increasing doses from virus vaccine vials

Fri January 8, 2021 5:20 AM |Associated Press|About: AZN, MRNA, PFE Associated Press, The

BRUSSELS (AP) — Germany’s Health Ministry says European Union regulators have approved doctors drawing up to six doses from each vial of the coronavirus vaccine made by BioNTech-Pfizer vaccine.

https://seekingalpha.com/pr/18144145-eu-regulators-ok-increasing-doses-from-virus-vaccine-vials

Prognosis

Pfizer, BioNTech Shot May Defeat New Variants, Study Shows

By Naomi Kresge and Jason GaleJanuary 8, 2021, 2:09 AM EST Updated on January 8, 2021, 10:17 AM EST

Study looked at mutation common to U.K., South Africa strains
The early data hasn’t yet been subjected to peer review

https://www.bloomberg.com/news/articles/2021-01-08/pfizer-shot-may-be-effective-against-key-mutation-study-shows

AN IN VITRO STUDY SHOWS PFIZER-BIONTECH COVID-19 VACCINE ELICITS ANTIBODIES THAT NEUTRALIZE SARS-COV-2 WITH A MUTATION ASSOCIATED WITH RAPID TRANSMISSION

Friday, January 08, 2021 - 12:00am

New York, NY and Mainz, Germany, January 8, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available here.

https://www.pfizer.com/news/press-release/press-release-detail/vitro-study-shows-pfizer-biontech-covid-19-vaccine-elicits

HEALTH AND SCIENCE

Pfizer-BioNTech vaccine found to be effective against Covid variant discovered in the UK

PUBLISHED WED, JAN 20 20215:30 AM ESTUPDATED WED, JAN 20 20216:43 AM EST KEY POINTS

The variant, known as B.1.1.7., has an unusually high number of mutations and is associated with more efficient and rapid transmission.
It had led to concerns about the effectiveness of Covid vaccines against it.
Authors of the study warned the rapid spread of Covid variants worldwide required “continuous monitoring of the significance of changes for maintained protection by currently authorized vaccines.”

https://www.cnbc.com/2021/01/20/covid-pfizer-biontech-vaccine-likely-to-be-effective-against-uk-variant.html?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

https://biontech.de/

https://seekingalpha.com/symbol/BNTX

https://www.pfizer.com/

https://seekingalpha.com/symbol/PFE

CORONAVIRUS DISEASE (COVID-19) RESOURCES

Risankizumab (SKYRIZI®)

January 5, 2021

Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients

- In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001)[1]
- KEEPsAKE-1 and KEEPsAKE-2 evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs)[1]
- The safety results in these studies to-date were generally consistent with the known profile of risankizumab in psoriasis patients[1-4]
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with active psoriatic arthritis and several other immune-mediated diseases[1,5-7]

NORTH CHICAGO, Ill., Jan. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).1

Risankizumab (SKYRIZI®)

About risankizumab (SKYRIZI®)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.12,13 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease and psoriatic arthritis are ongoing.5-7,10,11 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About SKYRIZI (risankizumab-rzaa) in the United States13

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

https://www.skyrizi.com/

For more information about AbbVie, please visit us at www.abbvie.com.

https://www.abbvie.com/

https://seekingalpha.com/pr/18139591-risankizumab-skyrizi-phase-3-results-demonstrate-improvements-in-disease-activity-across

AbbVie's risankizumab shows positive action in patients with psoriatic arthritis

Jan. 05, 2021 9:06 AM ETAbbVie Inc. (ABBV)By: Mamta Mayani, SA News Editor6 Comments

https://seekingalpha.com/news/3648797-abbvies-risankizumab-shows-positive-action-in-patients-psoriatic-arthritis

January 7, 2021

Risankizumab (SKYRIZI®) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease
- A significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab (600 mg or 1200 mg) achieved both primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response at week 12 compared to placebo[1,2]
- The overall safety results in these studies were generally consistent with the known safety profile of risankizumab, with no new safety risks observed[1-6]
- Risankizumab (SKYRIZI), an interleukin-23 (IL-23) inhibitor, is being evaluated as a treatment for adults with moderate to severe Crohn's disease and several other immune-mediated conditions[1,2,7,8]
- More than 3.5 million people globally live with inflammatory bowel diseases (IBD), including Crohn's disease, and the incidence continues to rise[9]

NORTH CHICAGO, Ill., Jan. 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV)

https://news.abbvie.com/news/press-releases/risankizumab-skyrizi-demonstrates-significant-improvements-in-clinical-remission-and-endoscopic-response-in-two-phase-3-induction-studies-in-patients-with-crohns-disease.htm?_ga=2.121540616.1236831060.1610036649-1604238744.1608750284

Multiplicity-adjusted key secondary endpoints included clinical response (per CDAI) at week 4 defined as a decrease in CDAI score from baseline of ≥100 points (CDAI100). More information can be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).

ABBV

AbbVie's risankizumab shows improvements in clinical remission and endoscopic response in Crohn's disease
Today, 9:12 AM | 5 Comments

https://seekingalpha.com/symbol/ABBV

USE for SKYRIZI® (risankizumab-rzaa) SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq

Monday, Jan 4, 2021

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Genentech’s portfolio of medicines
BTD is based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer

Broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers

South San Francisco, CA -- January 4, 2021 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq

About tiragolumab
Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tiragolumab works as an immune amplifier, by potentially enhancing the body’s immune response. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response. Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T cells and enhance NK cell anti-tumor activity.

Tiragolumab (anti-TIGIT)

(RG6058, MTIG7192A)

https://www.genentechoncology.com/pipeline-molecules/tiragolumab.html

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat adults with:
A type of bladder and urinary tract cancer called urothelial carcinoma.

https://www.tecentriq.com/

Please visit http://www.Tecentriq.com for the full Tecentriq Prescribing Information for additional Important Safety Information.

For additional information about the company, please visit http://www.gene.com.

https://www.gene.com/

https://seekingalpha.com/symbol/RHHBY

Genentech’s Novel Anti-TIGIT Tiragolumab Granted FDA Breakthrough Therapy Designation in Combination With Tecentriq for PD-L1-High Non-Small Cell Lung Cancer

Tue January 5, 2021 1:00 AM|Business Wire|About: RHHBY

– Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Genentech’s portfolio of medicines –

– BTD is based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer –

– Broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://seekingalpha.com/pr/18138825-genentech-s-novel-anti-tigit-tiragolumab-granted-fda-breakthrough-therapy-designation-in

https://seekingalpha.com/news/3648626-genentech-s-tiragolumab-tecentriq-nabs-accelerated-review-in-u-s-for-non-small-cell-lung

Tiragolumab (anti-TIGIT) (RG6058, MTIG7192A)

FARXIGA® (dapagliflozin)

FARXIGA granted Priority Review in the US for the treatment of patients with chronic kidney disease

PUBLISHED6 January 2021

FARXIGA could become the first SGLT2 inhibitor approved to treat
patients with chronic kidney disease, with and without type 2 diabetes

AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).

In March 2020, an independent Data Monitoring Committee recommended the trial be stopped early, based on its determination of overwhelming efficacy. Detailed results from the DAPA-CKD trial were shared in August 2020 and published in The New England Journal of Medicine.

FARXIGA® (dapagliflozin)

Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.

https://www.farxiga.com/

What is FARXIGA?

FARXIGA is a prescription medicine used to:

improve blood sugar control along with diet and exercise in adults with type 2 diabetes

reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors

reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)

FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

https://www.farxiga.com/

For more information, please visit www.astrazeneca-us.com

FARXIGA Granted Priority Review in the US for the Treatment of Patients With Chronic Kidney Disease

Wed January 6, 2021 7:00 AM|Business Wire|About: AZN

FARXIGA could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with and without type 2 diabetes

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).

https://seekingalpha.com/pr/18140943-farxiga-granted-priority-review-in-us-for-treatment-of-patients-chronic-kidney-disease

https://seekingalpha.com/symbol/AZN

AstraZeneca’s Farxiga nabs U.S. Priority Review for CKD

Jan. 06, 2021 9:15 AM ET AstraZeneca PLC (AZN)By: Vandana Singh, SA News Editor

https://seekingalpha.com/news/3649261-astrazeneca-s-farxiga-nabs-u-s-priority-review-for-ckd

What is FARXIGA? FARXIGA is a prescription medicine used to: improve blood sugar control along with diet and exercise in adults with type 2 diabetes reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

selinexor, XPOVIO®

Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL

Jan 04, 2021View PDF

Shanghai and Hong Kong, PRC, January 4, 2021-- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO®) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 (selinexor, XPOVIO®) as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 (selinexor, XPOVIO®) was granted orphan drug designation in South Korea in October 2020 and our US partner Karyopharm received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.

Antengene Announces Submission of IND Application in China for a Global Phase 3 Trial of ATG-010 (Selinexor) in Advanced or Recurrent Endometrial Cancer

Mon January 4, 2021 7:00 PM|PR Newswire| About: KPTI

SHANGHAI and HONG KONG, Jan. 4, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK)

https://seekingalpha.com/pr/18138746-antengene-announces-submission-of-ind-application-in-china-for-global-phase-3-trial-of

Karyopharm/Antengene files application for ATG-010 in China for endometrial cancer

Jan. 04, 2021 11:35 PM ET Karyopharm Therapeutics Inc. (KPTI)By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3648622-karyopharm-antengene-files-application-for-atgminus-010-in-china-for-endometrial-cancer

selinexor, XPOVIO®

About ATG-010 (selinexor, XPOVIO®)

ATG-010 (selinexor, XPOVIO®), a first-in-class and only-in-class oral selective inhibitor of nuclear export compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including the Greater China, South Korea, Australia, New Zealand and the ASEAN countries. In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO®) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO®) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO®) in this same rrMM indication. On December 18, 2020, the supplemental New Drug Application (sNDA) with a request for an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA. Selinexor (XPOVIO®) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved by the FDA for the treatment of both MM and DLBCL. Selinexor (XPOVIO®) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral selinexor (XPOVIO®) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO®) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

https://www.xpovio.com/?gclid=Cj0KCQiAlsv_BRDtARIsAHMGVSbnIxYOWrsPBGLDhCR5jxe980dg7vyoRTDAR3jtnGihWklrbqAD9s0aAs47EALw_wcB

What is XPOVIO?

XPOVIO® (selinexor) is a prescription medicine used:

in combination with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy.

https://www.xpovio.com/

https://www.antengene.com/

Pipeline

https://www.antengene.com/rd#rd_4

https://www.karyopharm.com/

https://seekingalpha.com/symbol/KPTI

Karyopharm/Antengene files South Korean application for ATG-010 in blood cancer

Jan. 04, 2021 2:11 AM ETKaryopharm Therapeutics Inc. (KPTI)By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3648209-karyopharm-antengene-files-south-korean-application-for-atgminus-010-in-blood-cancer

What is XPOVIO? XPOVIO® (selinexor) is a prescription medicine used: in combination with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy. It is not known if XPOVIO is safe and effective in children less than 18 years of age.

Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial

A Second Chinese Vaccine Is Said to Be Effective

Sinovac Biotech has sold more than 300 million doses to the developing world, filling a gap left by Western countries. Here’s the latest pandemic news.

Prognosis

Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial

By Andre Romani Pinto January 7, 2021, 9:19 AM EST Updated on January 7, 2021, 10:43 AM EST

Previous data on Chinese-developed shot had sparked confusion
Sinovac can make more than 600 million doses a year in China

https://www.bloomberg.com/news/articles/2021-01-07/sinovac-covid-shot-78-effective-in-brazil-trial-folha-reports

Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial

Most definitive data so far may shore up confidence in vaccine’s effectiveness after previous findings sowed confusion and doubt

Jan 08, 2021 05:30 AM

Sinovac’s Covid-19 Vaccine Is 78% Effective in Brazil Late-Stage Trials

China’s shot also gives 100% protection against severe cases of the disease, raising hopes it can be widely used in the developing world

https://www.wsj.com/articles/sinovacs-covid-19-vaccine-is-78-effective-in-brazil-late-stage-trials-11610032825

Sinovac Biotech

http://www.sinovac.com/?optionid=455

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial Prof Yanjun Zhang, PhD * Gang Zeng, PhD * Hongxing Pan, MSc * Prof Changgui Li, PhD * Yaling Hu, MSc Kai Chu, MSc et al. Show all authors Show footnotes Published:November 17, 2020DOI:https://doi.org/10.1016/S1473-3099(20)30843-4 PlumX Metrics

Tisotumab Vedotin

Genmab Announces Phase 3 Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Jan 4, 2021 at 8:00 PM CET

Media Release

COPENHAGEN, Denmark, Jan. 04, 2021

Initiation of a global phase 3 trial for tisotumab vedotin versus investigator’s choice chemotherapy in recurrent or metastatic cervical cancer

Genmab A/S (Nasdaq: GMAB) announced today the initiation of innovaTV 301 trial, a global phase 3 study to evaluate the efficacy of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy. The innovaTV 301 trial is a global, randomized phase 3 trial in which tisotumab vedotin will be compared with physician’s choice single agent chemotherapy.

Tisotumab Vedotin

About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.

For more information, please visit Genmab.com.

Genmab A/S (Nasdaq: GMAB)

https://seekingalpha.com/symbol/GMAB

Genmab launches late-stage tisotumab study in cervical cancer

Jan. 04, 2021 3:33 PM ETGenmab A/S (GMAB)By: Aakash Babu, SA News Editor

https://seekingalpha.com/news/3648467-genmab-launches-late-stage-tisotumab-study-in-cervical-cancer

Tisotumab vedotin is designed to target tissue factor (TF) using our proprietary antibody–drug conjugate (ADC) technology. TF is highly expressed on many solid tumors, including ovarian, prostate, bladder, esophageal, endometrial, and lung tumors.1,2,3

Tisotumab vedotin is being developed in collaboration with Genmab.

https://www.seagen.com/science/pipeline/tisotumab-vedotin

PIPELINE

We turn science into medicine

https://www.genmab.com/pipeline/

https://www.seagen.com/

https://seekingalpha.com/symbol/SGEN

Loncastuximab Tesirine

ADC Therapeutics Initiates Expanded Access Program for Loncastuximab Tesirine in the U.S.

JANUARY, 07, 2021

LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today the initiation of an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.

Loncastuximab Tesirine

About Loncastuximab Tesirine

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

A Biologics License Application for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021. Lonca is being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

https://adctherapeutics.com/our-pipeline1-1/adct-402-lonca/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005169/en/

https://ir.adctherapeutics.com/overview/default.aspx

ADCT

ADC Therapeutics initiates expanded access program for loncastuximab tesirine in the U.S.
Today, 10:35 AM

https://seekingalpha.com/symbol/ADCT

LEAD CANDIDATE Loncastuximab Tesirine (Lonca) Lonca is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and conjugated through a linker to a PBD-dimer toxin. Once bound to a CD19-expressing cell, Lonca is internalized into the cell where enzymes release the PBD-based warhead.

Roche’s Actemra (tocilizumab) & Sanofi’s Kevzara (sarilumab)

Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab)

Results

Tocilizumab and sarilumab both met the pre-defined triggers for efficacy. At the time of full analysis 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to control. Median organ support-free

days were 10 (interquartile range [IQR] -1, 16), 11 (IQR 0, 16) and 0 (IQR -1, 15)for tocilizumab, sarilumab and control, respectively. Relative to control, median adjusted odds ratios were 1.64(95% credible intervals [CrI] 1.25, 2.14) for tocilizumab and 1.76(95%CrI 1.17, 2.91) for sarilumab, yielding >99.9% and 99.5% posterior probabilities of superiority compared with control. Hospital mortality was28.0% (98/350) for tocilizumab, 22.2% (10/45) for sarilumab and 35.8% (142/397) for control. All secondary outcomes and analyses supported efficacy of theseIL-6 receptor antagonists.

Tocilizumab and sarilumab

https://www.actemra.com/

https://www.kevzara.com/

(ClinicalTrials.gov number: NCT02735707)

The new tongue-twisting drugs that can 'cut the risk of death by up to 24%': Boris Johnson hails 'life-saving' arthritis drugs trial (after stumbling over how to pronounce them)

UK-led study investigated two drugs: tocilizumab and sarilumab
These anti-inflammatory treatments are currently used to treat arthritis
REMAP-CAP trial found they are effective at treating severely-ill Covid patients
Without the drugs patients had a death rate of 35.8% and with the drugs this dropped to 25.3%

By JOE PINKSTONE FOR MAILONLINE

PUBLISHED: 11:00 EST, 7 January 2021 | UPDATED: 12:53 EST, 7 January 2021

https://www.dailymail.co.uk/sciencetech/article-9122747/Two-arthritis-drugs-slash-risk-Covid-patients-ICU-dying-24.html?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link

Roche/Sanofi treatment combo improves survival rates in COVID-19 – Study

Jan. 07, 2021 12:54 PM ET Sanofi (SNY) By: Dulan Lokuwithana, SA News Editor

A combination of drugs from Sanofi (NASDAQ:SNY) and Roche (OTCQX:RHHBY) has improved the survival rates and sped up the recovery in critically ill COVID-19 patients, Daily Mail reports, quoting the results of a study published online today.

https://seekingalpha.com/news/3649703-roche-sanofi-treatment-combo-improves-survival-rates-in-covidminus-19-study

UK approves anti-inflammatory drugs to treat sickest covid-19 patients after strong results in clinical trial

By Carolyn Y. Johnson and Ben Guarino

https://www.washingtonpost.com/health/2021/01/08/covid-arthritis-drugs-treatment/

https://seekingalpha.com/symbol/SNY

https://seekingalpha.com/symbol/RHHBY

What does ACTEMRA treat? ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist. ACTEMRA is used to treat: Adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well Adults with giant cell arteritis (GCA) Patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older Patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

SEEKING BIOTECH ALPHA = BIOTECMAX THE HEART OF BIOTEC 6/25/2024

biotecMAX™ January/ February/March/April 2021 Insight

KEYTRUDA® (pembrolizumab)

Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery

Merck’s Keytruda succeeds in late-stage trial as monotherapy in kidney cancer

XIENCE™ STENT

Abbott's XIENCE stent indication gets European approval

Tisotumab Vedotin

Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

FDA accepts Genmab, Seagen's tisotumab vedotin BLA application for review

OPDIVO® (nivolumab) Plus Chemotherapy

Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

TYSABRI® (NATALIZUMAB)

THE EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR NEW SUBCUTANEOUS ADMINISTRATION OF TYSABRI® (NATALIZUMAB) TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS

Biogen's TYSABRI wins EC approval for multiple sclerosis indication

RINVOQTM (upadacitinib)

AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis

FDA extends review of Abbvie's sNDA for Rinvoq in atopic dermatitis

TRODELVY™ (sacituzumab govitecan-hziy)

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

Gilead wins full FDA approval for Trodelvy in triple-negative breast cancer

XB002

FDA accepts Exelixis' XB002 application in advanced solid tumors

Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone

FDA approves Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma

Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone

FDA approves Sanofi's Sarclisa for another multiple myeloma indication

VIR-7831

Vir Biotechnology Announces New Preclinical Research Demonstrating VIR-7831 Maintains Neutralizing Activity Against the SARS-CoV-2 California Variant

Vir Biotechnology posts new preclinical research of VIR-7831 in SARS-CoV-2

AbCellera and Gilead ink new multi-year antibody discovery collaboration

AbCellera and Gilead Sciences Announce New Multi-Year, Multi-Target Antibody Discovery Collaboration

Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera’s entire technology stack, including the Trianni Mouse® and the OrthoMab bispecific platforms

AbCellera and Gilead ink new multi-year antibody discovery collaboration

Tecartus®

Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Tecartus®

Gilead submits sBLA for Tecartus for acute lymphoblastic leukemia

OUR PIPELINE

LEADING THE WAY IN CELL THERAPY

biotecMAX™ January/ February/March 2021 Insight

COVID-19 vaccine BNT162b2

PFIZER-BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS OF PIVOTAL COVID-19 VACCINE STUDY IN ADOLESCENTS

Pfizer/BioNTech report positive data for COVID-19 shot in adolescents

The Pfizer-BioNTech COVID-19 Vaccine Was Granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)

Pfizer Vaccine Gives 100% Protection at Ages 12-15 in Study

Pfizer-BioNTech Vaccine Said to Be Powerfully Protective in Adolescents

BioNTech-Pfizer vaccine shows '100% efficacy' for young teens

Pfizer Shot Remains More Than 91% Effective After Six Months

Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study

XOSPATA® (gilteritinib)

Astellas' Xospata meets overall survival endpoint in late-stage blood cancer study

EYLEA® (AFLIBERCEPT) INJECTION

NIH-SPONSORED TRIAL FINDS EYLEA® (AFLIBERCEPT) INJECTION REDUCED VISION-THREATENING COMPLICATIONS BY 68% AFTER TWO YEARS IN DIABETIC RETINOPATHY PATIENTS

Regeneron's Eylea reduces vision loss by 68% after two years in diabetic retinopathy

QINLOCK® (Ripretinib)

China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)

Indication

Zai Lab, Deciphera's Qinlocked OK'd in China for gastrointestinal tumors

Saxenda® (liraglutide 3.0 mg)

Saxenda® recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years

Novo Nordisk wins EU recommendation for Saxenda label update

Kesimpta® (ofatumumab)

Genmab Announces European Marketing Authorization for Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis

Genmab's Kesimpta OK'd in Europe for multiple sclerosis

Pemazyre® (pemigatinib)

Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

Pemazyre® (pemigatinib)

Incyte's Pemazyre wins European Commission approval to treat rare form of cancer

U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine

FDA accepts Abbvie's atogepant application for migraine

Lenzilumab

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

Humanigen surges on positive Phase 3 data for COVID-19 therapy

VASCEPA®/VAZKEPA

AMARIN RECEIVES EUROPEAN COMMISSION (EC) APPROVAL FOR VAZKEPA TO REDUCE CARDIOVASCULAR RISK

Amarin wins EU approval for icosapent ethyl to treat cardiovascular patients

Leronlimab (PRO 140)

CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients

CytoDyn’s leronlimab reduces mortality by 82% at 14 days in critically ill COVID-19 patients

79% vaccine efficacy at preventing symptomatic COVID-19

100% efficacy against severe or critical disease and hospitalisation

Comparable efficacy result across ethnicity and age,
with 80% efficacy in participants aged 65 years and over

Favourable reactogenicity and overall safety profile