Seeking Biotech Alpha DECEMBER 2019 Insight

Vicinium®

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Sesen Bio Completes Successful CMC Type B pre-BLA Meeting with FDA

Wed December 4, 2019 4:30 PM|Business Wire|About: SESN

Company gained FDA alignment on the final content of the BLA

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (SESN)

https://ir.sesenbio.com/news-releases/news-release-details/sesen-bio-completes-successful-cmc-type-b-pre-bla-meeting-fda

https://www.businesswire.com/news/home/20191204005921/en/

VICINIUM FOR BLADDER CANCER our initial focus for vicinium is on treating bladder cancer.

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder

Thu December 5, 2019 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Dec. 5, 2019 /PRNewswire/ --

Results from initial 6-patient cohort show pozelimab reduced lactate dehydrogenase (LDH) to normal levels at week 8 in patients with paroxysmal nocturnal hemoglobinuria (PNH), utilizing a weekly subcutaneous dosing regimen

Second part of Phase 2 trial initiated; plans for Phase 3 program underway

Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)

https://www.prnewswire.com/news-releases/regeneron-announces-positive-topline-phase-2-data-with-anti-c5-antibody-pozelimab-in-patients-with-a-rare-blood-disorder-300969698.html

https://www.regeneron.com/

https://www.regeneron.com/pipeline

https://seekingalpha.com/news/3523950-regenerons-pozelimab-shows-positive-effect-in-pnh-study

December 5, 2019 at 7:00 AM EST Back REGENERON ANNOUNCES POSITIVE TOPLINE PHASE 2 DATA WITH ANTI-C5 ANTIBODY POZELIMAB IN PATIENTS WITH A RARE BLOOD DISORDER TARRYTOWN, N.Y., Dec. 5, 2019 /PRNewswire/ -- Results from initial 6-patient cohort show pozelimab reduced lactate dehydrogenase (LDH) to normal levels at week 8 in patients with paroxysmal nocturnal hemoglobinuria (PNH), utilizing a weekly subcutaneous dosing regimen Second part of Phase 2 trial initiated; plans for Phase 3 program underway Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

LYNPARZA® (olaparib)

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

ambulant diagnostic technology for coagulation testing

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

Thu December 5, 2019 6:45 AM|Business Wire|About: MRK

AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Versus Placebo in BRCAm Advanced Ovarian Cancer Following Response to Platinum-Based Chemotherapy

Only PARP Inhibitor Approved in This Setting in China

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada

https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1

https://www.merck.com/clinical-trials/index.html

https://www.businesswire.com/news/home/20191205005115/en/

https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-approved-china-first-line-maintenance-therapy-brca-mutated-b

https://seekingalpha.com/news/3523919-astrazenecas-lynparza-okd-in-china-for-1st-line-maintenance-of-ovarian-cancer

LYNPARZA is a prescription medicine used to treat adults who have: advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

ambulant diagnostic technology for coagulation testing

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

ambulant diagnostic technology for coagulation testing

http://elearning.wfh.org/resource/general-care-and-management-of-hemophilia/

Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

Thu December 5, 2019 3:00 AM|PR Newswire|About: TAK

NIJMEGEN, Netherlands, Dec. 5, 2019 /PRNewswire/ -- Enzyre

https://www.prnewswire.com/news-releases/takeda-and-enzyre-to-develop-diagnostic-device-allowing-hemophilia-patients-to-determine-their-coagulation-status-at-home-300969334.html

http://www.enzyre.com/

Game Changer in Near Patient Diagnostics Focused on Blood Coagulation

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Bayer enters into collaboration with Children's Hospital of Philadelphia to research novel small molecule therapies for the oral treatment of hemophilia

Thu December 5, 2019 7:00 AM|PR Newswire

WHIPPANY, N.J., Dec. 5, 2019 /PRNewswire/

https://seekingalpha.com/news/3523958-bayer-to-collaborate-philadelphia-pediatric-hospital-on-hemophilia-treatments

https://www.bayer.com/

https://media.bayer.com/baynews/baynews.nsf/id/news-overview-category-search-en#/search

https://www.prnewswire.com/news-releases/bayer-enters-into-collaboration-with-childrens-hospital-of-philadelphia-to-research-novel-small-molecule-therapies-for-the-oral-treatment-of-hemophilia-300969689.html

Children's Hospital of Philadelphia

aducanumab

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Biogen's aducanumab showed mixed results in Alzheimer's studies

Dec. 5, 2019 11:41 AM ET|About: Biogen Inc. (BIIB)|By: Douglas W. House, SA News Editor

https://clinicaltrials.gov/ct2/show/NCT02484547?intr=BIIB-037&lead=biogen&phase=2&draw=2&rank=2

https://clinicaltrials.gov/ct2/show/NCT02477800?intr=BIIB-037&lead=biogen&phase=2&draw=2&rank=1

https://seekingalpha.com/symbol/BIIB

http://investors.biogen.com/static-files/ddd45672-9c7e-4c99-8a06-3b557697c06f

EMERGE and ENGAGE Topline Results: Two Phase 3 Studies to Evaluate Aducanumab in Patients With Early Alzheimer’s Disease December 5, 2019 CTAD 2019, San Diego, CA, USA 1Biogen, Cambridge, MA, USA

Seeking Biotech Alpha DECEMBER 2019 Insight

Tecentriq Plus Chemotherapy (Abraxane and Carboplatin)

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Tue December 3, 2019 6:30 PM|Business Wire|About: RHHBY

– Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.genentech-access.com/hcp.html

https://www.businesswire.com/news/home/20191203006105/en/

https://www.gene.com/topics/cancer-immunotherapy

https://www.tecentriq.com/

https://www.abraxanepro.com/

https://seekingalpha.com/news/3523561-fda-oks-roches-tecentriq-for-first-line-lung-cancer

CANCER IMMUNOTHERAPY Developing ways to help harness a person’s immune system to fight cancer.

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Company Investigation Confirms No Asbestos in Johnson's Baby Powder

Tue December 3, 2019 5:39 PM|PR Newswire|About: JNJPR Newswire

NEW BRUNSWICK, N.J., Dec. 3, 2019 /PRNewswire/ -- Johnson & Johnson Consumer Inc. (NYSE: JNJ)

https://www.factsabouttalc.com/

https://www.johnsonsbaby.com/

https://www.jnj.com/

https://www.prnewswire.com/news-releases/company-investigation-confirms-no-asbestos-in-johnsons-baby-powder-300968701.html

Company Investigation Confirms No Asbestos in Johnson’s Baby Powder More Than 150 Tests Show No Asbestos NEW BRUNSWICK, NJ, (December 3, 2019) – Johnson & Johnson Consumer Inc.

Reblozyl® (luspatercept-aamt)

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Reblozyl® (luspatercept-aamt)

Bristol-Myers Squibb and Acceleron Pharma Announce FDA Advisory Committee Will Review Reblozyl® (luspatercept-aamt) for Use in Patients With Myelodysplastic Syndromes

Tue December 3, 2019 7:38 AM|Business Wire|About: BMY, XLRN

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and Acceleron Pharma Inc. (XLRN)

https://media.celgene.com/content/uploads/reblozyl-pi.pdf

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-and-acceleron-pharma-announce-fda-advisor

http://acceleronpharma.com/science-pipeline/pipeline/

https://www.businesswire.com/news/home/20191203005566/en/

https://seekingalpha.com/news/3523331-fda-ad-com-set-for-bristol-myers-luspatercept-for-mds

http://acceleronpharma.com/

Pipeline

ORENCIA® (abatacept)

ubrogepant 50 mg and 100 mg

Reblozyl® (luspatercept-aamt)

Bristol-Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for ORENCIA® (abatacept) to Help Prevent Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

Wed December 4, 2019 6:59 AM|Business Wire|About: BMY

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY)

http://packageinserts.bms.com/pi/pi_orencia.pdf

https://www.businesswire.com/news/home/20191204005265/en/

https://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-us-fda-breakthrough-therapy-designation-orencia

https://www.bms.com/

https://seekingalpha.com/news/3523581-bristol-myers-orencia-nabs-accelerated-review-status-for-preventing-gvhd

What is ORENCIA? ORENCIA (abatacept) is a prescription biologic medicine for: Adult Rheumatoid Arthritis (RA) ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid Arthritis (RA) in adults 18 years and older. Taking ORENCIA may prevent further damage to your bones and joints, and may help your ability to perform daily activities. ORENCIA may help those who are not getting the results they need with other medicines for RA. In adults, ORENCIA may be used alone or with other RA treatments, but should not be used with TNF-blockers (also called Tumor Necrosis Factor antagonists). TNF-blockers are a type of RA medication, and include such treatments as Enbrel® (etanercept), Humira® (adalimumab), and Remicade® (infliximab). Juvenile Idiopathic Arthritis (JIA) ORENCIA is used to reduce signs and symptoms of moderate to severe polyarticular JIA in patients 2 years of age and older. ORENCIA may be used alone or with methotrexate (MTX). Adult Psoriatic Arthritis (PsA) ORENCIA is used to reduce signs and symptoms of active Psoriatic Arthritis (PsA) in adults 18 years and older. In adults, ORENCIA may be used alone or with other PsA treatments.

Tivozanib (FOTIVDA®)

ubrogepant 50 mg and 100 mg

AVEO Oncology Announces Lancet Oncology Publication of Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

Wed December 4, 2019 7:00 AM|Business Wire|About: AVEO

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AVEO Oncology (NASDAQ: AVEO)

https://www.businesswire.com/news/home/20191204005441/en/

https://www.aveooncology.com/product-candidates/tivozanib/

https://www.aveooncology.com/

Tivozanib (VEGFR 123 TKI) Tivozanib (FOTIVDA®) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

ubrogepant 50 mg and 100 mg

Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine

Wed December 4, 2019 5:26 PM|PR Newswire|About: AGN

-- Compared to placebo, ubrogepant 50 mg and 100 mg doses led to significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, a new, more stringent FDA standard in the acute treatment of migraine --

-- Ubrogepant 50 mg and 100 mg also met the secondary efficacy endpoint demonstrating clinically significant pain relief at two hours in the majority of patients studied versus placebo, a primary endpoint used in the studies of older migraine treatments, such as triptans --

-- FDA action on New Drug Application (NDA) expected in December 2019 for ubrogepant, which would make it the first oral CGRP blocker (gepant) to address unmet patient needs in acute treatment of migraine --

PR Newswire

DUBLIN, Dec. 4, 2019 /PRNewswire/ -- Allergan plc (AGN)

https://www.allergan.com/research-and-development/pipeline

https://www.prnewswire.com/news-releases/allergan-announces-positive-phase-3-achieve-i-trial-results-for-ubrogepant-published-in-the-new-england-journal-of-medicine-300969502.html

ALLERGAN ANNOUNCES POSITIVE PHASE 3 ACHIEVE I TRIAL RESULTS FOR UBROGEPANT PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

https://www.allergan.com/News/Details/2019/12/Allergan%20Announces%20Positive%20Phase%203%20ACHIEVE%20I%20Trial%20Results%20for%20Ubrogepant%20Published%20in%20The%20New%20Engl

Ubrogepant for the Treatment of Migraine List of authors. David W. Dodick, M.D., Richard B. Lipton, M.D., Jessica Ailani, M.D., Kaifeng Lu, Ph.D., Michelle Finnegan, M.P.H., Joel M. Trugman, M.D., and Armin Szegedi, M.D.

Seeking Biotech Alpha DECEMBER 2019 Insight

New Data Children's Oncology Trial (AALL1331) of BLINCYTO® (Blinatumomab) vs Chemotherapy

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

Amgen Announces Data Being Presented At ASH 2019

Mon December 2, 2019 4:00 PM|PR Newswire|About: AMGN

New Data From the Children's Oncology Group Phase 3 Trial (AALL1331) of BLINCYTO® (Blinatumomab) Versus Chemotherapy in First Relapse of Acute Lymphoblastic Leukemia Accepted as Late-Breaking Abstract

Data From Amgen's BiTE® Platform Demonstrate Versatility of Approach Across Four Hematological Malignancies

PR Newswire

THOUSAND OAKS, Calif., Dec. 2, 2019 /PRNewswire/ -- Amgen (AMGN)

https://www.prnewswire.com/news-releases/amgen-announces-data-being-presented-at-ash-2019-300967666.html

https://www.amgen.com/

https://www.amgen.com/media/news-releases/2019/12/amgen-announces-data-being-presented-at-ash-2019/

https://www.blincyto.com/

https://www.xgeva.com/

SCIENCE From innovative modalities to unique pathways, see how we’re advancing oncology treatment

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Tue December 3, 2019 7:30 AM|GlobeNewswire|About: BIIB

The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo
Positive results support Biogen’s goal of building a multi-franchise portfolio and underscore the company’s discovery and development capabilities

CAMBRIDGE, Mass., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (BIIB) (Nasdaq: BIIB)

https://www.biogen.com/en_us/pipeline.html

BIOGEN ANNOUNCES POSITIVE PHASE 2 STUDY RESULTS FOR CUTANEOUS LUPUS ERYTHEMATOSUS (CLE) AND SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) December 3, 2019 at 7:30 AM EST The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo Positive results support Biogen’s goal of building a multi-franchise portfolio and underscore the company’s discovery and development capabilities CAMBRIDGE, Mass., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (Nasdaq: BIIB)

HTX-011 for the management of postoperative pain

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

HTX-011 for the management of postoperative pain

Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain

Tue December 3, 2019 7:30 AM|PR Newswire|About: HRTX

SAN DIEGO, Dec. 3, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (HRTX)

http://www.herontx.com/

https://www.prnewswire.com/news-releases/health-canada-grants-priority-review-status-for-heron-therapeutics-new-drug-submission-for-htx-011-for-management-of-postoperative-pain-300967802.html

Heron's HTX-011 nabs accelerated review in Canada for management of postoperative pain

Dec. 3, 2019 7:45 AM ET|About: Heron Therapeutics, Inc. (HRTX)|By: Mamta Mayani, SA News Edito

https://seekingalpha.com/news/3523281-herons-htxminus-011-nabs-accelerated-review-in-canada-for-management-of-postoperative-pain

HTX-011 HTX-011 (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA or other international regulatory authority. HTX-011 is in development to reduce postoperative pain for 72 hours and reduce the need for opioid analgesics. It is an extended-release, dual-acting local anesthetic (DALA) applied into the surgical site. It utilizes a novel, synergistic mechanism of action that combines bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.

Halcyon™ treatment system

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

HTX-011 for the management of postoperative pain

Varian Further Expands Access to Care in Africa to Address Growing Cancer Burden

Tue December 3, 2019 8:15 AM|PR Newswire|About: VAR

PALO ALTO, Calif., Dec. 3, 2019 /PRNewswire/

https://www.prnewswire.com/news-releases/varian-further-expands-access-to-care-in-africa-to-address-growing-cancer-burden-300966401.html

https://www.varian.com/

Halcyon With its transformative features such as an intuitive workflow, simplified user interface, and human centered design, Halcyon™ is inspiring new victories in the fight against cancer.

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

Johnson & Johnson Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism; Launching Multi-Center, Post-Market Clinical Trials Across U.S.

Tue December 3, 2019 9:00 AM|PR Newswire|About: JNJ

-- Two post-market clinical trials initiating across U.S. to demonstrate rotational stability and visual outcomes

-- Nearly half of all cataract patients have astigmatism, yet often remain untreated due to concerns around rotational stability

PR Newswire

SANTA ANA, Calif., Dec. 3, 2019 /PRNewswire/ -- Johnson & Johnson Vision*

https://www.prnewswire.com/news-releases/johnson--johnson-vision-introduces-tecnis-toric-ii-1-piece-iol-as-new-monofocal-option-for-cataract-patients-with-astigmatism-launching-multi-center-post-market-clinical-trials-across-us-300968149.html

https://www.jjvision.com/

See Better - Connect Better - Live Better We are relentless in our pursuit to help people honor their eyes across their entire lives. Innovation is at the heart of our organization and embedded in all we do. It fuels our discovery and development of new products and also extends to our collaborations, education and community efforts to bring new solutions to those in need.

sacituzumab govitecan

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

Immunomedics Resubmits Biologics License Application to the FDA for Sacituzumab Govitecan

Tue December 3, 2019 8:00 AM|GlobeNewswire|About: IMMU

MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Immunomedics,

https://www.immunomedics.com/

https://www.immunomedics.com/our-science/pipeline/

https://seekingalpha.com/news/3523378-immunomedics-refiles-u-s-application-for-tnbc-candidate-shares-up-1

Pipeline

Seeking Biotech Alpha NOVEMBER 2019 Insight

SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

U.S. FDA Clears SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

Tue November 26, 2019 6:40 PM|GlobeNewswire|About: ISRG

Intuitive’s new sealing instrument and its first generator add versatility1

SUNNYVALE, Calif., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Intuitive (ISRG)

https://www.intuitive.com/en-us/products-and-services/da-vinci/systems

https://www.intuitive.com/en-us

Fourth generation da Vinci Surgical Systems continue to advance Minimally Invasive Surgery (MIS) across a wide spectrum of surgical procedures.1 Flexible configurations, upgradable architecture and a consistent interface distinguish our family of da Vinci systems. Standardization of instruments and components can help manage inventory and improve overall OR efficiency.

satralizumab (development code: SA237)

SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online

Thu November 28, 2019 9:00 PM|Business Wire|About: CHGCY, RHHBY

Satralizumab added to baseline immunosuppressant therapy significantly reduced risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD).
Satralizumab added to baseline therapy showed a well-tolerated safety profile.
SAkuraSky study is a global phase III clinical study for NMOSD patients including aquaporin-4 antibodies (AQP4-IgG) seropositive and seronegative patients

TOKYO--(BUSINESS WIRE)-- Chugai Pharmaceutical Co., Ltd. (CHGCF) (TOKYO:4519)

https://www.chugai-pharm.co.jp/english/

https://www.nejm.org/doi/full/10.1056/NEJMoa1901747

https://www.businesswire.com/news/home/20191128005586/en/

https://seekingalpha.com/pr/17714138-positive-phase-iii-results-genentech-s-satralizumab-neuromyelitis-optica-spectrum-disorder

https://www.businesswire.com/news/home/20191201005237/en/

Nov 29, 2019 Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online

Imfinzi (durvalumab)

SynchroSeal and E-100 Generator for da Vinci X/Xi Platforms

KEYTRUDA® (pembrolizumab)

Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer

PUBLISHED29 November 2019

29 November 2019 07:00 GMT

AstraZeneca

https://www.astrazeneca.com/

AstraZeneca lands fast review for Imfinzi

Nov. 29, 2019 7:49 AM ET|About: AstraZeneca PLC (AZN)|By: Clark Schultz, SA News Editor

https://seekingalpha.com/news/3522640-astrazeneca-lands-fast-review-imfinzi

HEALTH NEWSNOVEMBER 29, 2019 / 2:26 AM / UPDATED 6 HOURS AGO

AstraZeneca's Imfinzi gets speedy FDA review for small cell lung cancer

2 MIN RE

https://www.reuters.com/article/us-astrazeneca-imfinzi-fda/astrazenecas-imfinzi-gets-speedy-fda-review-for-small-cell-lung-cancer-idUSKBN1Y30LJ

IMFINZI® (durvalumab) is a prescription medicine used to treat 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.

KEYTRUDA® (pembrolizumab)

Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab)

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Mon December 2, 2019 6:45 AM|Business Wire|About: MRK

Application Based on Results from Phase 2 KEYNOTE-057 Trial, to be Discussed at December FDA Oncologic Drugs Advisory Committee (ODAC) Meeting

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,

https://clinicaltrials.gov/ct2/show/NCT02625961

https://www.merck.com/clinical-trials/index.html

https://www.businesswire.com/news/home/20191202005300/en/

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER. IT’S TRU. KEYTRUDA. Select cancer type ADVANCED NON–SMALL CELL LUNG CANCER MELANOMA HEAD AND NECK SQUAMOUS CELL CANCER ADVANCED UROTHELIAL BLADDER CANCER ADVANCED KIDNEY CANCER (RCC) MICROSATELLITE INSTABILITY- HIGH CANCER CLASSICAL HODGKIN LYMPHOMA ADVANCED GASTRIC CANCER ADVANCED CERVICAL CANCER PRIMARY MEDIASTINAL B‑CELL LYMPHOMA ADVANCED HEPATOCELLULAR CARCINOMA ADVANCED MERKEL CELL CARCINOMA ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Icosapent Ethyl (Vascepa®)

Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab)

European Medicines Agency Accepts for Review Marketing Authorization Application for Amarin’s Icosapent Ethyl (Vascepa®) for Reduction of Cardiovascular Risk in High-Risk Patients, as Reflected in REDUCE-IT® Study

Mon December 2, 2019 6:00 AM|GlobeNewswire|About: AMRN

DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN),

https://amarincorp.com/

https://investor.amarincorp.com/news-releases/news-release-details/european-medicines-agency-accepts-review-marketing-authorization

EMA accepts Amarin's marketing application for icosapent ethyl

Dec. 2, 2019 6:24 AM ET|About: Amarin Corporation plc (AMRN)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3522821-ema-accepts-amarins-marketing-application-icosapent-ethyl

VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab)

Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer

Mon December 2, 2019 8:00 AM|Business Wire|About: ALPMY, SGEN

- Companies to Initiate Phase 3 Trial to Support Global Registrations -

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. (ALPMF) (TSE: 4503,

https://www.businesswire.com/news/home/20191202005357/en/

https://www.cancer.net/cancer-types/bladder-cancer/introduction

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

https://www.seattlegenetics.com/

Enfortumab vedotin is an antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to our synthetic cell-killing agent, monomethyl auristatin E (MMAE), a microtubule-disrupting agent, using our proprietary linker technology. Enfortumab vedotin is the first agent to target Nectin-4, which is expressed on many solid tumors, with especially uniform expression on bladder cancers. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. We are co-developing enfortumab vedotin with Astellas.

Seeking Biotech Alpha NOVEMBER 2019 Insight

KEYTRUDA® (pembrolizumab)

Acthar® Gel (Repository Corticotropin Injection) Therapy

Merck’s KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

Tue November 26, 2019 6:45 AM|Business Wire|About: MRK

Third Approval for KEYTRUDA in First-Line NSCLC in China in Less Than One Year

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,

https://www.businesswire.com/news/home/20191126005394/en/

https://www.mrknewsroom.com/news-release/oncology-newsroom/mercks-keytruda-pembrolizumab-now-approved-china-first-line-treatment

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER. IT’S TRU. KEYTRUDA. = ADVANCED NON–SMALL CELL LUNG CANCER MELANOMA HEAD AND NECK SQUAMOUS CELL CANCER ADVANCED UROTHELIAL BLADDER CANCER ADVANCED KIDNEY CANCER (RCC) MICROSATELLITE INSTABILITY- HIGH CANCER CLASSICAL HODGKIN LYMPHOMA ADVANCED GASTRIC CANCER ADVANCED CERVICAL CANCER PRIMARY MEDIASTINAL B‑CELL LYMPHOMA ADVANCED HEPATOCELLULAR CARCINOMA ADVANCED MERKEL CELL CARCINOMA

Acthar® Gel (Repository Corticotropin Injection) Therapy

Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Symptomatic Sarcoidosis Published in Therapeutic Advances in Respiratory Disease

Tue November 26, 2019 6:45 AM|PR Newswire|About: MNK

-- Study showed an association between Acthar Gel treatment and improved overall health status in 95 percent of patients, along with a reduced use of concomitant medications --

-- The analysis showed an association between Acthar Gel treatment and a decrease in mean daily dose of corticosteroids from 18.2 mg to 9.9 mg --

PR Newswire

STAINES-UPON-THAMES, United Kingdom, Nov. 26, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK

http://www.mallinckrodt.com/about/news-and-media/news-detail/?id=26326

https://clinicaltrials.gov/ct2/show/NCT03320070

https://www.acthar.com/pdf/Acthar-PI.pdf

https://www.prnewswire.com/news-releases/data-on-acthar-gel-repository-corticotropin-injection-therapy-in-symptomatic-sarcoidosis-published-in-therapeutic-advances-in-respiratory-disease-300965058.html

http://www.mallinckrodt.com/products/brands/

What is Acthar Gel? Acthar® Gel (repository corticotropin injection) is used for: Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus) Treatment of infantile spasms in infants and children under 2 years of age Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease The reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus) Treatment for flares or on a regular basis (maintenance) in people with systemic dermatomyositis or polymyositis (DM-PM) Treatment for people with symptoms of sarcoidosis Adjunctive therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina Acthar is injected beneath the skin or into the muscle.

Agilent Technologies Inc (A). (NYSE: A)

Acthar® Gel (Repository Corticotropin Injection) Therapy

elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis= “NASH”

Agilent Receives Multiple Life Science Industry Awards for Innovation

Tue November 26, 2019 8:00 AM|Business Wire|About: A

https://www.agilent.com/

https://www.businesswire.com/news/home/20191126005181/en/

AGILENT

elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis= “NASH”

GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH

Tue November 26, 2019 2:46 AM|GlobeNewswire|About: GNFT

GENFIT: Positive 42-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH

Data Safety Monitoring Board (DSMB) recommends the continuation of the RESOLVE-IT clinical trial without any modifications, based on the pre-planned review of safety data
DSMB guidance remains consistent, supporting favorable safety profile of elafibranor

Lille (France), Cambridge (Massachusetts, United States), November 26, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT)

https://www.genfit.com/pipeline/elafibranor/

https://ml-eu.globenewswire.com/Resource/Download/12e07f8b-6afb-4b50-b4ec-3bce9cc11397

https://www.amf-france.org/

https://www.genfit.com/

Elafibranor in NASH We are currently evaluating our lead drug candidate, elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis, or “NASH”. In its preliminary phases, including its international phase 2b study in NASH, elafibranor’s unique mechanism of action targeting both PPARa and PPARd has shown positive effects on many of the key hallmarks of NASH, while maintaining a favorable safety and tolerability, representing great hope for patients who today have no available therapeutic options.

QIAGEN and DiaSorin launches QuantiFERON-TB Plus test

elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis= “NASH”

pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor

QIAGEN and DiaSorin Receive FDA Approval for The LIAISON QuantiFERON-TB Gold Plus Test on LIAISON Platforms and Begin Commercial Launch

Wed November 27, 2019 2:00 AM|Business Wire|About: QGEN

Enabling highly automated screening solution for latent tuberculosis in all throughput segments

Germantown, Md. & HILDEN, Germany & SALUGGIA, Italy--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and DiaSorin (DSRLF) (FTSE MIB: DIA)

https://www.businesswire.com/news/home/20191126005848/en/

https://www.qiagen.com/us/

https://www.diasorin.com/home/

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics. DiaSorin is listed on the MTA (automated stock market) in the FTSE Italia Mid Cap Index, organized and managed by Borsa Italiana S.p.A For over 40 years the Group has been developing, producing and commercializing diagnostic tests for a wide range of clinical areas. DiaSorin tests are designed for hospital and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor

elafibranor, in a pivotal phase 3 study for the treatment of nonalcoholic steatohepatitis= “NASH”

pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor

Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma

Wed November 27, 2019 7:30 AM|Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

https://clinicaltrials.gov/ct2/show/NCT02924376

https://www.incyte.com/

https://www.businesswire.com/news/home/20191127005145/en/

Press Release Incyte Announces Acceptance and Priority Review of NDA for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma WILMINGTON, Del.--(BUSINESS WIRE)--Nov. 27, 2019-- Incyte (Nasdaq:INCY)

Seeking Biotech Alpha NOVEMBER 2019 Insight

Dengue Vaccine Candidate

KarXT = oral xanomeline = muscarinic receptor agonist) & trospium (a muscarinic receptor antagonist)

Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting

Sat November 23, 2019 10:30 AM|Business Wire|About: TAK

− Data presented from the pivotal Phase 3 trial include an update on overall efficacy of the vaccine candidate, as well as formal analyses of secondary efficacy endpoints by serotype, baseline serostatus and disease severity −

− 18-month results build upon the efficacy and safety data reported in the 12-month analysis; overall vaccine efficacy remained generally consistent and the trial met all secondary endpoints for which there were a sufficient number of cases; safety and efficacy will be assessed over a total of four and a half years –

− Takeda (TKPHF) presented 11 abstracts across its vaccine pipeline at ASTMH, including oral presentations on its dengue and Zika vaccine candidates −

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502 / NYSE:TAK)

https://clinicaltrials.gov/ct2/show/record/NCT02747927?term=den-301&rank=1&view=record

https://www.takeda.com/

https://www.takedavaccines.com/

https://www.businesswire.com/news/home/20191123005045/en/

Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting November 23, 2019 − Data presented from the pivotal Phase 3 trial include an update on overall efficacy of the vaccine candidate, as well as formal analyses of secondary efficacy endpoints by serotype, baseline serostatus and disease severity − − 18-month results build upon the efficacy and safety data reported in the 12-month analysis; overall vaccine efficacy remained generally consistent and the trial met all secondary endpoints for which there were a sufficient number of cases; safety and efficacy will be assessed over a total of four and a half years – − Takeda presented 11 abstracts across its vaccine pipeline at ASTMH, including oral presentations on its dengue and Zika vaccine candidates − Cambridge, Mass., and Osaka, Japan, November 23, 2019 – Takeda Pharmaceutical Company Limited (TSE:4502 / NYSE:TAK) (“Takeda”) today announced that updated results from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES)

KarXT = oral xanomeline = muscarinic receptor agonist) & trospium (a muscarinic receptor antagonist)

Karuna Therapeutics Announces KarXT Met Primary Endpoint in Phase 2 Clinical Trial of Acute Psychosis in Patients with Schizophrenia

Mon November 18, 2019 6:00 AM|Business Wire|About: KRTX

KarXT Demonstrated Statistically Significant and Clinically Meaningful Improvement in Total PANSS Score at All Time Points Over Five Weeks and was Well-Tolerated Compared to Placebo

Improvement in Total PANSS Score at Five Weeks was 11.6 Points Compared to Placebo (p<0.0001)

No Evidence of Somnolence, Extrapyramidal Side Effects or Weight Gain Relative to Placebo

Data Support Advancing KarXT to Phase 3 and Continued Development in Other CNS Disorders

Conference Call and Webcast to Take Place Today at 8:30 a.m. EST

BOSTON--(BUSINESS WIRE)-- Karuna Therapeutics, Inc. (KRTX),

https://clinicaltrials.gov/ct2/show/NCT03697252?lead=karuna&phase=1&draw=2&rank=1

https://karunatx.com/

https://seekingalpha.com/news/3520035-karuna-86-percent-premarket-positive-karxt-data

https://www.businesswire.com/news/home/20191118005243/en/

Pipeline Our pipeline is built on the broad therapeutic potential of our lead product candidate, KarXT, an oral modulator of muscarinic receptors that are located both in the central nervous system (CNS) and various peripheral tissues. KarXT is our proprietary product candidate that combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS.

Novartis nears $7B deal for The Medicines Co.

KarXT = oral xanomeline = muscarinic receptor agonist) & trospium (a muscarinic receptor antagonist)

risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier

BUSINESS

Novartis Nears Deal to Buy Cholesterol-Drug Maker The Medicines Co.

Acquisition would help Novartis bulk up in the heart-treatments market

Novartis Chief Executive Vas Narasimhan has been steering the Swiss drugmaker toward newer technologies through deals. PHOTO: ARND WIEGMANN/REUTERS

By Dana Cimilluca, Cara Lombardo and Jonathan D. RockoffUpdated Nov. 23, 2019 10:06 pm ET

Novartis AG NVS -0.06% is nearing a deal to buy cholesterol-drug maker The Medicines Co. for nearly $7 billion, in an expensive bid to expand its reach in the lucrative market for heart treatments.

https://seekingalpha.com/news/3521670-novartis-nears-7b-deal-medicines-co

https://www.themedicinescompany.com/

ORION clinical development program At The Medicines Company, we are devoted to the development of inclisiran – a small interfering RNA (siRNA) therapy being studied to evaluate its ability to lower low-density lipoprotein (LDL) cholesterol – also known as LDL-C or bad cholesterol. Inclisiran is designed to prevent the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) at its primary source in the liver. Inclisiran is not yet approved for use by the FDA or any other regulatory authority.

risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier

FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

Mon November 25, 2019 1:00 AM|Business Wire|About: RHHBY

– Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.businesswire.com/news/home/20191124005113/en/

https://www.gene.com/

PIPELINE

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

https://www.gene.com/medical-professionals/pipeline

Sunday, Nov 24, 2019 FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people living with Types 1, 2 or 3 SMA South San Francisco, CA -- November 24, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier

ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

Mon November 25, 2019 8:00 AM|Business Wire|About: SGEN

- Approval of Supplemental New Drug Submission for ADCETRIS in Combination with CHP Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma based on Positive Phase 3 ECHELON-2 Clinical Trial Results -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)

https://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-Announces-Progress-in-Expanding-ADCETRIS-Brentuximab-Vedotin-Indications-in-Canada/default.aspx

https://www.businesswire.com/news/home/20191125005237/en/

https://www.adcetris.com/#page-isi

https://www.seattlegenetics.com/pipeline/brentuximab-vedotin

https://www.seattlegenetics.com/

ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 cHL: Adult patients with newly diagnosed Stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy (adriamycin, vinblastine, and dacarbazine) Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Previously untreated sALCL or other CD30-expressing PTCL: Adult patients with newly diagnosed systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with chemotherapy (cyclophosphamide, doxorubicin, and prednisone) Relapsed sALCL: Adult patients with sALCL after at least 1 combination chemotherapy treatment fails Relapsed pcALCL or CD30-expressing MF: Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy (treatment that reaches and affects the entire body)

XTANDI® (enzalutamide)

risdiplam, an investigational survival motor neuron-2 (SMN-2) splicing modifier

ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

Mon November 25, 2019 7:00 PM|PR Newswire|About: ALPMY, PFEPR Newswire

TOKYO, Nov. 25, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503,

https://www.prnewswire.com/news-releases/astellas-announces-the-approval-of-xtandi-enzalutamide-by-the-china-national-medical-products-administration-nmpa-300964935.html

https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

https://www.astellas.com/en/news/15446

What is XTANDI? XTANDI is a prescription medicine used to treat men with prostate cancer that no longer responds to a medical or surgical treatment that lowers testosterone

Seeking Biotech Alpha NOVEMBER 2019 Insight

VUMERITY™ (diroximel fumarate) FDA-approved treatment for relapsing forms of multiple sclerosis (MS)

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate)

Fri November 22, 2019 7:30 AM|GlobeNewswire|About: BIIB

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB)

https://www.vumerity.com/content/dam/commercial/vumerity/pat/en_us/pdf/vumerity-prescribing-information.pdf

https://seekingalpha.com/news/3521496-biogens-ms-drug-shows-improved-gi-tolerability-vs-tecfidera

https://www.vumerity.com/en_us/home.html

https://www.biogen.com/

BIOGEN PRESENTS DATA DEMONSTRATING IMPROVED GASTROINTESTINAL TOLERABILITY WITH VUMERITY™ (DIROXIMEL FUMARATE) COMPARED TO TECFIDERA® (DIMETHYL FUMARATE)

November 22, 2019 at 7:30 AM EST

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)

http://investors.biogen.com/news-releases/news-release-details/biogen-presents-data-demonstrating-improved-gastrointestinal

VUMERITY is a prescription medicine used to treat people with 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 VUMERITY is safe and effective in children. NOW APPROVED Introducing a new oral option for patients with relapsing forms of multiple sclerosis

SOLIRIS® (Eculizumab)

VUMERITY™ (diroximel fumarate) FDA-approved treatment for relapsing forms of multiple sclerosis (MS)

SOLIRIS® (eculizumab) Receives Approval in Japan for the Prevention of Relapse in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Fri November 22, 2019 8:30 AM|Business Wire|About: ALXN

- SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Japan -

- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN)

https://www.solirisrems.com/

https://www.businesswire.com/news/home/20191122005192/en/

https://seekingalpha.com/news/3521518-alexion-pharmaceuticals-gains-approval-soliris-japan

Friday, November 22, 2019 8:30 am EST

SOLIRIS® (Eculizumab) Receives Approval In Japan For The Prevention Of Relapse In Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

- SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Japan -

- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -

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BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)

https://news.alexion.com/press-release/product-news/soliris-eculizumab-receives-approval-japan-prevention-relapse-patients-ne

Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris is indicated for the treatment of patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). atypical Hemolytic Uremic Syndrome (aHUS) Soliris is indicated for the treatment of adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Limitation of use: Soliris is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Anti-AChR Antibody-Positive generalized Myasthenia Gravis (gMG) Soliris is indicated for the treatment of adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. Anti-AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) Soliris is indicated for the treatment of adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

PD-L1 IHC 22C3 pharmDx -identifying HNSCC patients for treatment w/ KEYTRUDA® (pembrolizumab) in Eur

VUMERITY™ (diroximel fumarate) FDA-approved treatment for relapsing forms of multiple sclerosis (MS)

PD-L1 IHC 22C3 pharmDx -identifying HNSCC patients for treatment w/ KEYTRUDA® (pembrolizumab) in Eur

Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC)

Fri November 22, 2019 8:43 AM|Business Wire|About: A

PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab) in Europe

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A)

https://www.businesswire.com/news/home/20191122005275/en/

https://www.agilent.com/about/newsroom/presrel/2019/22nov-ca19033.html

https://www.agilent.com/search/?N=900010356&Ntt=PD+L1+IHC+22C3+pharmDx

Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC) PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying HNSCC patients for treatment with KEYTRUDA® (pembrolizumab) in Europe SANTA CLARA, Calif., November 22, 2019 Agilent Technologies, Inc. (NYSE: A) today announced that its PD-L1 IHC 22C3 pharmDx assay is now labeled for use in HNSCC in the European Union. The assay is CE-IVD–marked as an aid in identifying HNSCC patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada). KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumors express PD-L1 with a CPS ≥ 1.

Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)

PD-L1 IHC 22C3 pharmDx -identifying HNSCC patients for treatment w/ KEYTRUDA® (pembrolizumab) in Eur

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

Fri November 22, 2019 11:05 AM|Business Wire|About: RHHBY

– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib –

– Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.tecentriq.com/

https://www.avastin.com/

https://www.businesswire.com/news/home/20191122005376/en/

https://www.gene.com/

CANCER IMMUNOTHERAPY Developing ways to help harness a person’s immune system to fight cancer.

ALUNBRIG® (brigatinib)

Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)

ALUNBRIG® (brigatinib)

Takeda Presents Long-Term Data in ALK+ NSCLC Showing ALUNBRIG® (brigatinib) Continues to Demonstrate Superiority in the First-Line After Two Years of Follow-Up

Fri November 22, 2019 10:00 PM|Business Wire|About: TAK

– ALUNBRIG Reduced the Risk of Disease Progression or Death by 76% in Patients whose Disease Had Spread to the Brain, and by 57% in All Patients, when Compared to Crizotinib –

– Median Progression-Free Survival with ALUNBRIG was Three Times Longer than that with Crizotinib –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

Regeneron Pharmaceuticals (REGN) Presents At Jefferies Global Healthcare Conference - Slideshow

Nov. 22, 2019 2:10 PM ET | About: Regeneron Pharmaceuticals, Inc. (REGN)

https://www.businesswire.com/news/home/20191122005494/en/

https://www.takeda.com/

https://www.takeda.com/newsroom/newsreleases/2019/takeda-presents-long-term-data-in-alk-nsclc-showing-alunbrig-brigatinib-continues-to-demonstrate-superiority-in-the-first-line-after-two-years-of-follow-up/

About ALUNBRIG® (brigatinib) ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target and inhibit the anaplastic lymphoma kinase (ALK) fusion protein in non-small cell lung cancer (NSCLC). In April 2017, ALUNBRIG received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC patients who have progressed on or are intolerant to crizotinib. 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 a confirmatory trial. ALUNBRIG is currently approved in more than 40 countries, including the U.S., Canada and the European Union, for the treatment of people with ALK+ metastatic NSCLC whose disease has worsened during crizotinib treatment or they could not tolerate taking crizotinib.

Tislelizumab

Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab)

ALUNBRIG® (brigatinib)

BeiGene Announces Clinical Data on Tislelizumab Presented at European Society for Medical Oncology (ESMO) Asia 2019 Congress

Sat November 23, 2019 5:00 AM|GlobeNewswire|About: BGNE

CAMBRIDGE, Mass. and BEIJING, China, Nov. 23, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.globenewswire.com/NewsRoom/AttachmentNg/afe76614-5866-42d4-9623-adfe526c7ec6

https://www.beigene.com/

https://www.beigene.com/science-and-product-portfolio/pipeline?loc=US

https://www.beigene.com/science-and-product-portfolio/pipeline/tislelizumab

Tislelizumab Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.

Seeking Biotech Alpha NOVEMBER 2019 InsighT

valoctocogene roxaparvovec

SYMPHONY Occipito-Cervico-Thoracic (OCT) System

valoctocogene roxaparvovec

BioMarin Submits Marketing Authorization Application to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

Thu November 21, 2019 4:04 PM|PR Newswire|About: BMRN

Application Expected to be Reviewed Under Expedited Accelerated Assessment Designation

PR Newswire

SAN RAFAEL, Calif., Nov. 21, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.prnewswire.com/news-releases/biomarin-submits-marketing-authorization-application-to-european-medicines-agency-for-valoctocogene-roxaparvovec-to-treat-severe-hemophilia-a-300963370.html

https://www.biomarin.com/products/pipeline

https://investors.biomarin.com/2019-11-21-BioMarin-Submits-Marketing-Authorization-Application-to-European-Medicines-Agency-for-Valoctocogene-Roxaparvovec-to-Treat-Severe-Hemophilia-A

Pipeline BioMarin is actively developing promising first-in-class or best-in-class therapies to treat rare genetic diseases, which mostly affect children. The company has a growing product pipeline, with multiple clinical and preclinical candidates in development.

Calquence (acalabrutinib)

SYMPHONY Occipito-Cervico-Thoracic (OCT) System

valoctocogene roxaparvovec

Calquence approved in the US for adult patients with chronic lymphocytic leukaemia

PUBLISHED21 November 2019

21 November 2019 18:10 BST

Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Calquence combined with obinutuzumab and as monotherapy reduced
the risk of disease progression or death by 90% and 80%,
respectively in ELEVATE-TN

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programmes.

FDA OKs AstraZeneca's Calquence for lymphocytic leukemia

Nov. 21, 2019 2:13 PM ET|About: AstraZeneca PLC (AZN)|By: Carl Surran, SA News Editor

https://seekingalpha.com/news/3521306-fda-oks-astrazenecas-calquence-lymphocytic-leukemia

AstraZeneca is excited to announce that CALQUENCE is now approvedfor the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). LEARN MORE ABOUT CALQUENCE FOR YOUR PATIENTS WITH CLL/SLL

SYMPHONY Occipito-Cervico-Thoracic (OCT) System

New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders

Thu November 21, 2019 9:02 AM|PR Newswire|About: JNJPR Newswire

NEW YORK, Nov. 21, 2019 /PRNewswire/ -- The Johnson & Johnson Medical Devices Companies*

https://www.prnewswire.com/news-releases/new-cervical-spine-system-from-depuy-synthes-advances-treatment-options-for-patients-with-complex-cervical-spine-disorders-300963037.html

https://www.jnjmedicaldevices.com/en-US/news-events/new-cervical-spine-system-depuy-synthes-advances-treatment-options-patients-complex

New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders 21 November 2019

IN.PACT™ AV drug-coated balloon

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

SYMPHONY Occipito-Cervico-Thoracic (OCT) System

Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions

Thu November 21, 2019 11:05 AM|GlobeNewswire|About: MDT

Clinical Data Demonstrates IN.PACT™ AV DCB Is Safe, Reduces Reinterventions, and Maintains Access for End-Stage Renal Disease Patients Undergoing Dialysis

DUBLIN, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)

IN.PACT Admiral Drug-Coated Balloon

Paclitaxel Coated Balloon

https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/drug-coated-balloons/inpact-drug-coated-balloon.html

Medtronic lands FDA approval for renal disease treatment

Nov. 21, 2019 11:13 AM ET|About: Medtronic plc (MDT)|By: Clark Schultz, SA News Editor

https://seekingalpha.com/news/3521268-medtronic-lands-fda-approval-renal-disease-treatment

IN.PACT Admiral Drug-Coated Balloon Paclitaxel Coated Balloon

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

Thu November 21, 2019 8:30 AM|PR Newswire|About: ABBV

- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)

- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)

- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

PR Newswire

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (ABBV)

https://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-research-in-the-treatment-of-leukemias-lymphomas-and-other-blood-cancers-at-2019-ash-annual-meeting-300962704.html

https://www.imbruvica.com/

https://www.venclextahcp.com/cll.html

AbbVie in oncology Our oncology story began with a focus on attacking an “unhittable” cancer target.

Otezla® (apremilast)

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

Amgen Completes Acquisition Of Otezla® (apremilast)

Thu November 21, 2019 6:21 AM|PR Newswire|About: AMGN, BMY, CELGPR Newswire

THOUSAND OAKS, Calif., Nov. 21, 2019 /PRNewswire/ -- Amgen (AMGN) today announced the successful completion of its acquisition of worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for moderate-to-severe plaque psoriasis and psoriatic arthritis. Otezla was acquired from Celgene Corporation (CELG) in connection with its previously announced merger with Bristol-Myers Squibb Company (BMY), which was completed on Nov. 20.

Amgen Completes Acquisition Of Otezla® (apremilast)

Differentiated Therapy Strengthens Amgen's Long-Standing Expertise in Inflammation

THOUSAND OAKS, Calif., Nov. 21, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

https://www.amgen.com/media/news-releases/2019/11/amgen-completes-acquisition-of-otezla-apremilast/

https://www.prnewswire.com/news-releases/amgen-completes-acquisition-of-otezla-apremilast-300962932.html

Otezla® (apremilast) is a prescription medicine approved for the treatment of 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.

Seeking Biotech Alpha NOVEMBER 2019 Insight

INVOKANA® (canagliflozin)

icosapent ethyl (Vascepa®)

Janssen Leverages Wearable Technology to Reimagine Clinical Trial Design

Sat November 16, 2019 9:15 AM|PR Newswire

Company tests innovative trial design with potential to bring medicines to patients faster and more cost-effectively

PR Newswire

TITUSVILLE, N.J., Nov. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKANA-pi.pdf

https://www.janssen.com/cardiovascular-and-metabolism

https://www.jnj.com/johnson-johnson-announces-research-study-with-apple-watch-to-help-improve-afib-outcomes-including-stroke-prevention

https://www.prnewswire.com/news-releases/janssen-leverages-wearable-technology-to-reimagine-clinical-trial-design-300959419.html

https://www.invokana.com/splash-home

https://seekingalpha.com/news/3520157-j-and-j-launches-innovative-study-expanded-use-invokana

Janssen Leverages Wearable Technology to Reimagine Clinical Trial Design Nov 16, 2019 United States CHIEF-HF is the first-ever completely decentralized, mobile, indication-seeking study assessing effectiveness of INVOKANA® (canagliflozin) in adults with heart failure (HF), with or without type 2 diabetes (T2D) Company tests innovative trial design with potential to bring medicines to patients faster and more cost-effectively TITUSVILLE, N.J., Nov. 16, 2019 -- The Janssen Pharmaceutical Companies of Johnson & Johnson

icosapent ethyl (Vascepa®)

https://www.abstractsonline.com/pp8/#!/7891/presentation/35097

Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions

Mon November 18, 2019 5:30 PM|GlobeNewswire|About: AMRN

REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction in all-cause mortality

New analysis determined icosapent ethyl (Vascepa®) is highly cost-effective in patients from the REDUCE-IT study and, as is rarely found, may result in net healthcare cost-savings to patients, payers and society

Data showed prevalence of elevated risk of major cardiovascular events (mean 10-year ASCVD risk score greater than 20%) in more than 20% of patients on statins with triglycerides below 150 mg/dL

Interim EVAPORATE study provides important mechanistic data with relevance to the reduction in cardiovascular events seen in the REDUCE-IT clinical trial; final study results likely in early 2020

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://www.abstractsonline.com/pp8/#!/7891/presentation/40313

https://www.abstractsonline.com/pp8/#!/7891/presentation/33779

https://www.abstractsonline.com/pp8/#!/7891/presentation/35090

https://amarincorp.com/products.html

https://investor.amarincorp.com/static-files/c2473067-dcab-47ea-9968-b908da51c671

WHAT IS VASCEPA? VASCEPA is a prescription medicine used 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 prevents you from having a heart attack or stroke.

SB8 Bevacizumab Biosimilar

icosapent ethyl (Vascepa®)

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

November 19, 2019 05:00 AM Eastern Standard Time

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd.

https://www.businesswire.com/news/home/20191119005429/en/

If approved, Merck (NYSE:MRK) will commercialize.

https://seekingalpha.com/news/3520355-fda-accepts-bioepis-application-avastin-biosimilar

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug

Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder

Tue November 19, 2019 7:00 AM|PR Newswire|About: ALKS

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)

https://www.prnewswire.com/news-releases/alkermes-submits-new-drug-application-to-us-food-and-drug-administration-for-alks-3831-for-treatment-of-schizophrenia-and-bipolar-i-disorder-300960407.html

Alkermes plc (ALKS) Investor Presentation - Sliideshow

Nov. 20, 2019 5:13 AM ET | About: Alkermes plc (ALKS)

https://seekingalpha.com/article/4307949-alkermes-plc-alks-investor-presentation-sliideshow

Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug

DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone

Genmab Announces European Marketing Authorization for DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone in Frontline Multiple Myeloma

Tue November 19, 2019 11:14 AM|GlobeNewswire|About: GMAB

Company Announcement

DARZALEX® approved in Europe in combination with lenalidomide and dexamethasone as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
Approval follows positive opinion by European Committee for Medicinal Products for Human Use (CHMP) in October
Approval based on data from Phase III MAIA study

Copenhagen, Denmark; November 19, 2019 – Genmab A/S (GNMSF) (Nasdaq: GMAB)

http://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

European Commission approves the use of Johnson & Johnson (JNJ -0.2%) unit Janssen Biotech's Darzalex (daratumumab), combined with Celgene's Revlimid (lenalidomide) and dexamethasone

https://seekingalpha.com/news/3520513-expanded-use-j-and-js-darzalex-okd-europe

DARZALEX® (daratumumab) IS NOW APPROVED ACROSS NEWLY DIAGNOSED PATIENTS WITH MULTIPLE MYELOMA DARZALEX® (daratumumab) in combination with the medicines Revlimid® (lenalidomide) and dexamethasone (DRd) for adult patients with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant). LEARN MORE ABOUT THE DRd REGIMEN DARZALEX® (daratumumab) in combination with the medicines Velcade® (bortezomib) + thalidomide + dexamethasone (DVTd) for adult patients with newly diagnosed multiple myeloma who can receive an autologous stem cell transplant.

Ubrogepant 50 mg and 25 mg

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug

DARZALEX® (Daratumumab) in Combination with Lenalidomide and Dexamethasone

Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association

Tue November 19, 2019 11:22 AM|PR Newswire|About: AGN

-- Acute treatment of migraine with ubrogepant compared with placebo led to significantly greater rates of pain freedom at two hours with both the 50 mg and 25 mg doses, and freedom from the most bothersome migraine-associated symptom at two hours with the 50 mg dose --

-- FDA action on New Drug Application (NDA) expected in December 2019 for ubrogepant, potentially making it the first oral CGRP to address unmet patient needs in acute treatment of migraine and the first FDA-approved gepant --

PR Newswire

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Allergan plc (AGN)

https://www.allergan.com/News/Details/2019/11/Allergan%20Announces%20Positive%20Phase%203%20ACHIEVE%20II%20Trial%20Results%20for%20Ubrogepant%20Published%20in%20The%20Journal

https://www.prnewswire.com/news-releases/allergan-announces-positive-phase-3-achieve-ii-trial-results-for-ubrogepant-published-in-the-journal-of-the-american-medical-association-300961106.html

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE I)

Seeking Biotech Alpha NOVEMBER 2019 Insight

Perjeta (pertuzumab)

PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

Perjeta (pertuzumab)

Genentech to Present New and Updated Data for Seven Approved and Investigational Medicines Across Multiple Types of Breast Cancer at the 2019 San Antonio Breast Cancer Symposium

Mon November 18, 2019 1:00 AM|Business Wire|About: RHHBY

— Study results reflect advancements in HER2-positive, triple-negative, and hormone receptor-positive breast cancer —

— Follow-up data from pivotal Phase III APHINITY study evaluating Perjeta plus Herceptin and chemotherapy in HER2-positive early breast cancer —

— Results from Phase III FeDeriCa study confirming the non-inferiority of a fixed-dose combination of Perjeta and Herceptin administered under the skin —

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.gene.com/download/pdf/perjeta_prescribing.pdf

https://www.herceptin.com/

https://www.gene.com/download/pdf/herceptin_prescribing.pdf

https://www.businesswire.com/news/home/20191117005086/en/

https://www.gene.com/

What does PERJETA treat? PERJETA® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin® (trastuzumab) and chemotherapy for: use prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than 2 cm in diameter or node-positive). PERJETA should be used as part of a complete treatment regimen for early breast cancer. use after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back. PERJETA® (pertuzumab) is a prescription medicine approved for use in combination with Herceptin® (trastuzumab) and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Leronlimab (PRO 140)

PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

Perjeta (pertuzumab)

CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in March 2020

Mon November 18, 2019 6:00 AM|GlobeNewswire|About: CYDY

Independent data from the PRESTIGIO Registry Study Group in Italy shows leronlimab inhibits multi-drug resistant HIV-1 viruses in Heavily Treatment-Experienced (HTE) patients

VANCOUVER, Washington, Nov. 18, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

https://www.cytodyn.com/newsroom/press-releases/detail/356/cytodyn-treats-first-patient-in-phase-1b2-clinical-trial

https://seekingalpha.com/symbol/CYDY

Pipeline

PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

Ontario and Quebec provide reimbursement for HIV therapies PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

Mon November 18, 2019 7:00 AM|Canada Newswire|About: MRK

Although treatment progress has been made, human immunodeficiency virus (HIV) is still one of the world's most serious public health challenges.i In 2018, approximately 37.9 million people were living with HIV worldwide.ii During that same year, an estimated 1.7 million people became newly infected globally.iii
For more than 30 years, Merck (MRK) has been committed to scientific research and discovery in HIV that addresses unmet medical needs and helps people living with HIV have a long and healthy life.

KIRKLAND, QC, Nov. 18, 2019 /CNW/ - Merck Canada Inc., an affiliate of Merck & Co., Inc.,

https://www.merck.ca/static/pdf/PIFELTRO-PM_E.pdf

DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not taken HIV-1 medicines before. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

https://www.delstrigo.com/

Ask your healthcare provider if PIFELTRO is right for you.

ABRILADA™ (adalimumab-afzb)

vericiguat, a soluble guanylate cyclase (sGC) stimulator

PIFELTRO® (doravirine) and DELSTRIGO® (doravirine/lamivudine/tenofovir disoproxil fumarate)

FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions

Mon November 18, 2019 6:45 AM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

http://labeling.pfizer.com/ShowLabeling.aspx?id=12780

https://www.businesswire.com/news/home/20191118005208/en/

NEWS / FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions FDA APPROVES PFIZER’S BIOSIMILAR, ABRILADA™ (ADALIMUMAB-AFZB) FOR MULTIPLE INFLAMMATORY CONDITIONS Monday, November 18, 2019 - 6:45am EST Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab)

Omecamtiv Mecarbil

vericiguat, a soluble guanylate cyclase (sGC) stimulator

New Results From COSMIC-HF Presented At AHA 2019 Show Treatment Of Heart Failure Patients With Omecamtiv Mecarbil Was Associated With Neutral Or Improved Measures Of Diastolic Function

Mon November 18, 2019 9:00 AM|PR Newswire|About: AMGN, CYTK

THOUSAND OAKS, Calif., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Nov. 18, 2019 /PRNewswire/ -- Amgen (AMGN), Cytokinetics, Incorporated (CYTK)

https://cytokinetics.com/

https://servier.com/en/

https://www.prnewswire.com/news-releases/new-results-from-cosmic-hf-presented-at-aha-2019-show-treatment-of-heart-failure-patients-with-omecamtiv-mecarbil-was-associated-with-neutral-or-improved-measures-of-diastolic-function-300959718.html

https://cytokinetics.com/pipeline/

OMECAMTIV MECARBIL Cytokinetics is developing omecamtiv mecarbil, a novel, selective cardiac myosin activator for the potential treatment for heart failure with reduced ejection fraction (HFrEF). Omecamtiv mecarbil is an investigational drug candidate being developed under a collaboration between Amgen and Cytokinetics with funding and strategic support from Servier.

vericiguat, a soluble guanylate cyclase (sGC) stimulator

Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

Mon November 18, 2019 6:30 AM|Business Wire|About: MRK

Vericiguat Reduced the Risk of Heart Failure Hospitalization or Cardiovascular Death in Patients with Worsening Chronic Heart Failure with Reduced Ejection Fraction, Compared to Placebo When Added to Available Heart Failure Therapies

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada

https://www.ncbi.nlm.nih.gov/pubmed/24092345

https://www.businesswire.com/news/home/20191118005267/en/

https://seekingalpha.com/news/3520021-merck-bayers-vericiguat-successful-late-stage-heart-failure-study

https://www.mrknewsroom.com/news-release/research-and-development-news/merck-and-bayers-investigational-drug-vericiguat-meets-pr

*Adempas is approved to treat adults with: Chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) treated with surgery but who continue to have high pulmonary blood pressure (persistent) or it comes back after surgery (recurrent), or that cannot be treated with surgery (inoperable) Pulmonary arterial hypertension (PAH) (WHO Group 1)

Seeking Biotech Alpha NOVEMBER 2019 Insight

REVLIMID® (lenalidomide) in combination with rituximab (R²)

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

Fri November 15, 2019 7:30 AM|Business Wire|About: CELG

REVLIMID® and rituximab (R2) has the potential to become a chemotherapy-free combination treatment option for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

The positive opinion was based on the results of the Phase 3 AUGMENT study, which showed the R2 regimen conferred a statistically significantly improvement in progression-free survival versus rituximab monotherapy

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (CELG)

http://media.celgene.com/content/uploads/revlimid-pi.pdf

https://www.celgene.com/research-development/pipeline-pdf/

https://www.businesswire.com/news/home/20191115005209/en/

https://www.celgene.com/

https://revlimidrrfl.com/patient/

A new chemotherapy-free treatment combination REVLIMID® in combination with a rituximab product, is used to treat adult patients who have previously been treated for follicular lymphoma (FL). REVLIMID® in combination with a rituximab product, is used to treat adult patients who have previously been treated for marginal zone lymphoma (MZL)

Adakveo® (crizanlizumab)

REVLIMID® (lenalidomide) in combination with rituximab (R²)

FDA NEWS RELEASE

FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

November 15, 2019

https://seekingalpha.com/news/3519890-fda-oks-novartis-crizanlizumab-sickle-cell-disease

New Novartis medicine Adakveo® (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease Nov 15, 2019 Basel, November 15, 2019 – Novartis

Repatha® (evolocumab)

REVLIMID® (lenalidomide) in combination with rituximab (R²)

FARXIGA (dapagliflozin)

Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Sat November 16, 2019 9:00 AM|PR Newswire|About: AMGNPR Newswire

THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen (AMGN)

https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repatha/repatha_pi_hcp_english.ashx

Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Additional FOURIER Analysis Shows Lowering LDL-C With Repatha Did Not Impair Patient-Reported Cognition

THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ -- Amgen

https://www.amgen.com/media/news-releases/2019/11/amgen-announces-new-fourier-analysis-showing-benefit-of-repatha-evolocumab-in-highrisk-patients-who-have-experienced-a-recent-heart-attack/

Repatha® is an injectable prescription medicine used: in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery.

FARXIGA (dapagliflozin)

Jardiance® (empagliflozin)

FARXIGA (dapagliflozin)

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/consistent-effects-of-farxiga-in-heart-failure-patients-with-reduced-ejection-fraction-shown-in-new-analyses-from-landmark-phase-iii-dapa-hf-trial-11172019.html

Consistent Effects of FARXIGA in Heart Failure Patients With Reduced Ejection Fraction Shown in New Analyses From Landmark Phase III DAPA-HF Trial

Sun November 17, 2019 10:45 AM|Business Wire|About: AZN

Data were consistent in patients with and without type 2 diabetes, showed early effects in the first month and improvement in patient-reported outcomes

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca

https://www.azpicentral.com/farxiga/farxiga.pdf#page=1

Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg

https://www.businesswire.com/news/home/20191117005052/en/

What is FARXIGA? FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

Jardiance® (empagliflozin)

Interim analysis from EMPRISE real-world study shows Jardiance® decreased risk of hospitalization for heart failure compared with DPP-4 inhibitors and GLP-1 receptor agonists

Sun November 17, 2019 10:50 AM|PR Newswire|About: LLY

- A second analysis on healthcare resource utilization shows Jardiance was associated with a reduced risk in all-cause hospitalizations compared with DPP-4 inhibitors

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 17, 2019 /PRNewswire/

https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf?DMW_FORMAT=pdf

https://www.boehringer-ingelheim.us/innovation/pipeline

https://www.lillydiabetes.com/

https://investor.lilly.com/news-releases/news-release-details/interim-analysis-emprise-real-world-study-shows-jardiancer

https://www.prnewswire.com/news-releases/interim-analysis-from-emprise-real-world-study-shows-jardiance-decreased-risk-of-hospitalization-for-heart-failure-compared-with-dpp-4-inhibitors-and-glp-1-receptor-agonists-300959408.html

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).

BRILINTA (ticagrelor)

Jardiance® (empagliflozin)

Subgroup Analysis of TWILIGHT Trial Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Who Underwent PCI Showed BRILINTA Monotherapy Reduced the Risk of Clinically Relevant Bleeding Compared With Dual Antiplatelet Therapy (DAPT)

Sun November 17, 2019 11:47 AM|Business Wire|About: AZN

Secondary endpoint of subgroup analysis showed similar rates of the composite of all-cause death, myocardial infarction or stroke between monotherapy and DAPT

Results of subgroup analysis of TWILIGHT randomized clinical trial presented at AHA Scientific Sessions 2019

WILMINGTON, Del.--(BUSINESS WIRE)

https://www.azpicentral.com/brilinta/brilinta.pdf#page=1

https://www.nejm.org/doi/full/10.1056/NEJMoa1908419?query=featured_home

https://www.businesswire.com/news/home/20191117005054/en/

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/subgroup-analysis-of-twilight-trial-patients-with-non-st-elevation-acute-coronary-syndrome-nste-acs-who-underwent-pci-showed-brilinta-monotherapy-reduced-the-risk-of-clinically-relevant-bleeding-compared-with-dual-antiplatelet-therapy-dapt-11172019.html

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke

Seeking Biotech Alpha NOVEMBER 2019 Insight

empagliflozin 2.5 mg

Vosoritide (BMN 111) for Achondroplasia

Boehringer Ingelheim and Lilly announce outcome of FDA Advisory Committee meeting for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes

Wed November 13, 2019 5:07 PM|PR Newswire|About: LLY

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 13, 2019 /PRNewswire/

https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-announce-outcome-of-fda-advisory-committee-meeting-for-empagliflozin-2-5-mg-as-adjunct-to-insulin-for-adults-with-type-1-diabetes-300957896.html

https://www.lillydiabetes.com/

https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-and-lilly-announce-outcome-fda-advisory-committee-meeting

Boehringer Ingelheim and Lilly announce outcome of FDA Advisory Committee meeting for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes 11/13/2019

Vosoritide (BMN 111) for Achondroplasia

BioMarin Announces Cumulative Additional Height Gain of 9.0 cm over 54 months versus Natural History in Children with Achondroplasia Treated with Vosoritide in Phase 2 Study

Thu November 14, 2019 8:27 AM|PR Newswire|About: BMRN

Company Presents Data Confirming that the Phase 3 and Phase 2 Study Participants have Similar Baseline Parameters

PR Newswire

SAN RAFAEL, Calif., Nov. 14, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.prnewswire.com/news-releases/biomarin-announces-cumulative-additional-height-gain-of-9-0-cm-over-54-months-versus-natural-history-in-children-with-achondroplasia-treated-with-vosoritide-in-phase-2-study-300958408.html

https://clinicaltrials.gov/ct2/show/NCT02724228?cond=Achondroplasia&lead=biomarin&phase=12&draw=2&rank=1

https://investors.biomarin.com/2019-11-14-BioMarin-Announces-Cumulative-Additional-Height-Gain-of-9-0-cm-over-54-months-versus-Natural-History-in-Children-with-Achondroplasia-Treated-with-Vosoritide-in-Phase-2-Study

Vosoritide (BMN 111) for Achondroplasia Vosoritide is designed for the treatment of achondroplasia, the most common form of dwarfism.

MEK 1/2 inhibitor selumetinib

Vosoritide (BMN 111) for Achondroplasia

MEK 1/2 inhibitor selumetinib

US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review

Thu November 14, 2019 6:55 AM|Business Wire|About: MRK

AstraZeneca and Merck’s Selumetinib Would Become the First Medicine Indicated for the Treatment of Certain Pediatric Patients with NF1 Plexiform Neurofibromas if Approved

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada

https://www.businesswire.com/news/home/20191114005242/en/

https://www.merck.com/clinical-trials/index.html

https://ghr.nlm.nih.gov/condition/neurofibromatosis-type-1

https://www.mrknewsroom.com/news-release/oncology/us-fda-accepts-regulatory-submission-new-drug-application-selumetinib-neurofib

US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants Priority Review PUBLISHED 14 November 2019 14 November 2019 07:00 GMT AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with NF1 plexiform neurofibromas if approved AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada)

Vascepa (icosapent ethyl)

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin)

MEK 1/2 inhibitor selumetinib

FDA Ad Com thumbs up on CV benefit of Amarin's Vascepa

Nov. 14, 2019 4:09 PM ET|About: Amarin Corporation plc (AMRN)|By: Douglas W. House, SA News Editor

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial

Thu November 14, 2019 5:34 PM|GlobeNewswire|About: AMRN

https://seekingalpha.com/pr/17700484-amarin-announced-fda-advisory-committee-voted-unanimously-16minus-0-recommend-approval

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial November 14, 2019 Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN)

https://investor.amarincorp.com/node/18376/pdf

https://www.youtube.com/watch?v=VloIzGYw6vo

https://investor.amarincorp.com/news-releases/news-release-details/amarin-announced-fda-advisory-committee-voted-unanimously-16-0

Pharma

AHA: Amarin's Vascepa halts progression of arterial plaque in key study

by Kyle Blankenship | Nov 17, 2019 5:32pm

https://www.fiercepharma.com/pharma/aha-amarin-s-vascepa-halts-progression-arterial-plaque-interim-imaging-data

BRUKINSA™ (zanubrutinib)

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin)

U.S. FDA Grants BeiGene’s BRUKINSA™ (zanubrutinib) Accelerated Approval to Treat Adult Patients with Mantle Cell Lymphoma Who Received at Least One Prior Therapy

Thu November 14, 2019 4:20 PM|GlobeNewswire|About: BGNE

84% of patients taking BRUKINSA achieved an overall response1

- BRUKINSA is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells and the only BTK inhibitor with the flexibility to be taken once or twice daily

CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd.

https://www.beigene.com/PDF/BRUKINSAUSPI.pdf

https://ml.globenewswire.com/Resource/Download/c47ea153-ba25-4dd1-8155-937b64fdf4b7

https://ml.globenewswire.com/Resource/Download/aca04555-626d-4c35-821b-957abaab640c

https://www.beigene.com/products

IS NOW APPROVED FOR ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BRUKINSA (zanubrutinib) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin)

Qtrilmet approved in the EU for the treatment of type-2 diabetes

PUBLISHED15 November 2019

About Qtrilmet

Qtrilmet is a once-daily oral medicine comprised of the selective sodium‑glucose co-transporter 2 (SGLT2) inhibitor Forxiga, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor Onglyza and metformin hydrochloride extended release indicated as treatment in adults with T2D.

15 November 2019 07:00 GMT

Qtrilmet metformin hydrochloride / saxagliptin / dapagliflozin

Seeking Biotech Alpha NOVEMBER 2019 Insight

RINVOQ™ (upadacitinib)

Northern Ireland will have access to ORKAMBI® (lumacaftor/ivacaftor), SYMKEVI®, KALYDECO®

New Positive Data for RINVOQ™ (upadacitinib) on Signs and Symptoms in Patients with Ankylosing Spondylitis Presented at 2019 ACR/ARP Annual Meeting

Tue November 12, 2019 11:15 AM|PR Newswire|About: ABBV

- Full results were presented today at the 2019 ACR/ARP Annual Meeting in Atlanta

- The safety profile was consistent with that of previous studies across indications, with no new safety risks detected[1,2]

- Affecting more than five million people worldwide, AS is a chronic inflammatory disease that causes pain and stiffness in the joints, mainly in the spine[3,4]

PR Newswire

NORTH CHICAGO, Ill., Nov. 12, 2019 /PRNewswire/ -- AbbVie (ABBV)

www.clinicaltrials.gov (NCT03178487).

https://www.rxabbvie.com/pdf/rinvoq_pi.pdf

https://www.abbvie.com/our-science/pipeline.html

https://www.prnewswire.com/news-releases/new-positive-data-for-rinvoq-upadacitinib-on-signs-and-symptoms-in-patients-with-ankylosing-spondylitis-presented-at-2019-acrarp-annual-meeting-300956524.html

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.

Northern Ireland will have access to ORKAMBI® (lumacaftor/ivacaftor), SYMKEVI®, KALYDECO®

Vertex Confirms Northern Ireland Offer Accepted for Cystic Fibrosis Medicines

Tue November 12, 2019 10:51 AM|Business Wire|About: VRTX

-Eligible patients in Northern Ireland will soon have access to ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor), expanded access to KALYDECO® (ivacaftor) under same terms as NHS England agreement-

LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX)

https://www.businesswire.com/news/home/20191112005777/en/

https://www.orkambi.com/

Research and Pipeline Vertex is focused on discovering, developing and commercializing innovative medicines so people with serious diseases can lead better lives. Our scientists don’t see the impossible as an obstacle; they see it as a good place to start. These studies are investigating treatments or outcomes that have not received approval from a health authority. The information presented is not intended to convey conclusions of safety or efficacy. There is no guarantee that the outcome of these studies will result in approval by a health authority.

Jardiance® (empagliflozin)

Northern Ireland will have access to ORKAMBI® (lumacaftor/ivacaftor), SYMKEVI®, KALYDECO®

Jardiance® (empagliflozin)

Boehringer Ingelheim and Lilly initiate first ever study to assess Jardiance® in people hospitalized for acute heart failure who have been stabilized

Tue November 12, 2019 8:30 AM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 12, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (LLY)

https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf?DMW_FORMAT=pdf

https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-and-lilly-initiate-first-ever-study-assess-jardiance-people?

https://www.lillydiabetes.com/

https://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-initiate-first-ever-study-to-assess-jardiance-in-people-hospitalized-for-acute-heart-failure-who-have-been-stabilized-300956005.html

https://investor.lilly.com/news-releases/news-release-details/boehringer-ingelheim-and-lilly-initiate-first-ever-study-assess

INGREZZA® (valbenazine)

Jardiance® (empagliflozin)

Neurocrine Biosciences Publishes Long-Term INGREZZA® (valbenazine) Data in the Journal of Clinical Psychopharmacology Demonstrating Once-Daily 40 mg and 80 mg Capsules Reduced Involuntary Movements in Adults with Tardive Dyskinesia

Tue November 12, 2019 4:01 PM|PR Newswire|About: NBIX

- INGREZZA Continues to Be Well Tolerated Through One Year of Treatment

PR Newswire

SAN DIEGO, Nov. 12, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)

https://www.prnewswire.com/news-releases/neurocrine-biosciences-publishes-long-term-ingrezza-valbenazine-data-in-the-journal-of-clinical-psychopharmacology-demonstrating-once-daily-40-mg-and-80-mg-capsules-reduced-involuntary-movements-in-adults-with-tardive-dyskinesi-300956831.html

https://www.neurocrine.com/pipeline/pipeline-overview/

https://www.ingrezza.com/PI

https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-publishes-long-term-ingrezzar-valbenazine

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

Rubraca® (rucaparib)

INGREZZA® (valbenazine)

Rubraca® (rucaparib)

Clovis Oncology Announces Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Italy

Wed November 13, 2019 4:00 AM|Business Wire|About: CLVS

Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
Rucaparib now reimbursed in several countries in Europe with additional countries to follow in 2020

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS)

https://www.clovisoncology.com/

https://www.clovisoncology.com/pipeline/pipeline-overview/

https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf

https://www.businesswire.com/news/home/20191113005122/en/

What is Rubraca? Rubraca® (rucaparib) tablets are a prescription medicine used for: The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy The treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer. Your healthcare provider will perform a test to make sure Rubraca is right for you

Nucala (mepolizumab)

INGREZZA® (valbenazine)

Rubraca® (rucaparib)

13 November 2019

Nucala (mepolizumab) is the first treatment to show a significant reduction in flares for patients with Hypereosinophilic Syndrome (HES)

Positive data from a pivotal study supports new regulatory filing in HES

Issued: London, UK

GlaxoSmithKline plc (GSK)

Glaxo's Nucala successful in pivotal HES study

Nov. 13, 2019 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3518541-glaxos-nucala-successful-pivotal-hes-study

NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.

Seeking Biotech Alpha NOVEMBER 2019 Insight

Risdiplam

NIS4, an Investigational Non-Invasive NASH Diagnostic

Genentech’s Risdiplam Meets Primary Endpoint in Pivotal SUNFISH Trial in People With Type 2 or 3 Spinal Muscular Atrophy

Mon November 11, 2019 1:00 AM|Business Wire|About: RHHBY

– Study demonstrated statistically significant improvements in the overall study population with Type 2 or 3 SMA –

– No treatment related safety findings leading to withdrawal seen in any risdiplam trial to date –

– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.businesswire.com/news/home/20191110005058/en/

https://clinicaltrials.gov/ct2/show/NCT02908685?titles=sunfish&lead=roche&draw=2&rank=1

Basel, Switzerland, South Plainfield, NJ, USA and New York, NY, USA, 29 November 2011

Roche signs agreement with PTC Therapeutics to advance treatment for Spinal Muscular Atrophy (SMA)

Basel, Switzerland, South Plainfield, NJ, USA and New York, NY, USA – November 29, 2011

Collaboration offers new hope for a potential treatment for the leading genetic cause of death in infants and toddlers

Roche (SIX: RO, ROG; OTCQX: RHHBY), PTC Therapeutics, Inc. (PTC) and the SMA Foundation

https://www.roche.com/media/releases/med-cor-2011-11-29t.htm

https://www.gene.com/

Medical Professionals / Our Pipeline PIPELINE Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

NIS4, an Investigational Non-Invasive NASH Diagnostic

GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019

Sun November 10, 2019 8:00 AM|GlobeNewswire|About: GNFT

GENFIT Announces Results of NIS4, an Investigational Non-Invasive NASH Diagnostic, at AASLD 2019

NIS4 is GENFIT’s innovative non-invasive in vitro diagnostic test, or IVD, to identify patients with NASH who may be appropriate candidates for drug therapy
Program is based on the in-house discovery of a 4-biomarker algorithm potentially replacing biopsy with a single blood test
Study finds patients living with type 2 diabetes are at increased risk of being diagnosed with NASH

Lille (France), Cambridge (Massachusetts, United States), November 10, 2019 – GENFIT (Nasdaq and Euronext: GNFT)

https://www.genfit.com/

https://ir.genfit.com/news-releases/news-release-details/genfit-announces-results-nis4-investigational-non-invasive-nash

Pipeline Discover our portfolio of innovative drug candidates and diagnostic solutions targeting metabolic and liver-related diseases.

Ervebo

NIS4, an Investigational Non-Invasive NASH Diagnostic

XELJANZ® (tofacitinib)

(Reuters)

HEALTH NEWSNOVEMBER 11, 2019 / 12:48 PM / UPDATED 2 HOURS AGO

Merck wins European approval for first-ever Ebola vaccine

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila

Merck Ebola vaccine OK'd in Europe

Nov. 11, 2019 1:59 PM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3517670-merck-ebola-vaccine-okd-europe

Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

Mon November 11, 2019 3:00 PM|Business Wire|About: MRK

https://seekingalpha.com/pr/17694535-merck-s-ervebo-ebola-zaire-vaccine-rvsv-g-zebov-gp-live-granted-conditional-approval-european

Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

Authorization Represents Significant Advancement in the Global Response to Ebola

Merck Remains Committed to Working with International Health Partners in Ebola Outbreak Response

Monday, November 11, 2019 3:00 pm EST

https://www.mrknewsroom.com/news-release/ebola/mercks-ervebo-ebola-zaire-vaccine-rvsvdg-zebov-gp-live-granted-conditional-approv

After more than two decades of research, the world finally has an approved Ebola vaccine. HEALTH Ebola vaccine approved in Europe in landmark moment in fight against a deadly disease By HELEN BRANSWELL @HelenBranswellNOVEMBER 11, 2019

XELJANZ® (tofacitinib)

VUMERITY™ (diroximel fumarate)

XELJANZ® (tofacitinib)

Pfizer Announces Results of Phase 3 Study for XELJANZ® (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting

Tue November 12, 2019 6:45 AM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

http://labeling.pfizer.com/ShowLabeling.aspx?id=959

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_results_of_phase_3_study_for_xeljanz_tofacitinib_in_juvenile_idiopathic_arthritis_ahead_of_presentation_at_2019_american_college_of_rheumatology_association_of_rheumatology_professionals_annual

https://clinicaltrials.gov/ct2/results?term=tofacitinib%2C+rheumatoid+arthritis%2C+ORAL&type=&rslt=&recr=&age_v=&gndr=&cond=Rheumatoid+Arthritis&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&rcv_s=&rcv_e=&lup_s=&lup_e=

https://www.businesswire.com/news/home/20191112005224/en/

XELJANZ/XELJANZ XR (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat: Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated Adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated XELJANZ is also used to treat: Adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated

Taltz® (ixekizumab)

VUMERITY™ (diroximel fumarate)

ACR 2019: Lilly Presents Positive New Data from COAST-X, a Phase 3 Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis

Tue November 12, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Nov. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)

http://uspl.lilly.com/taltz/taltz.html#pi

https://www.arthritis.org/about-arthritis/types/spondyloarthritis/

https://www.prnewswire.com/news-releases/acr-2019-lilly-presents-positive-new-data-from-coast-x-a-phase-3-study-of-taltz-ixekizumab-in-patients-with-non-radiographic-axial-spondyloarthritis-300954995.html

Important Facts About Taltz® (tȯl-ts). It is a prescription medicine also known as ixekizumab. Taltz is an injectable medicine used to treat adults: With moderate to severe plaque psoriasis. It is for people who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). With active psoriatic arthritis. With active ankylosing spondylitis.

VUMERITY™ (diroximel fumarate)

Alkermes Announces Receipt of $150 Million Milestone Payment from Biogen Related to FDA Approval of VUMERITY™

Tue November 12, 2019 7:00 AM|PR Newswire|About: ALKS, BIIB

DUBLIN, Nov. 12, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)

https://www.vumerity.com/content/dam/commercial/vumerity/pat/en_us/pdf/vumerity_prescribing_information.pdf

https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-receipt-150-million-milestone-payment-biogen

https://www.prnewswire.com/news-releases/alkermes-announces-receipt-of-150-million-milestone-payment-from-biogen-related-to-fda-approval-of-vumerity-300955769.html

What is VUMERITY™ (diroximel fumarate)? VUMERITY is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

Seeking Biotech Alpha NOVEMBER 2019 Insight

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma

Mon November 11, 2019 6:59 AM|Business Wire|About: BMY

The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)

https://www.businesswire.com/news/home/20191111005122/en/

https://packageinserts.bms.com/pi/pi_opdivo.pdf

https://packageinserts.bms.com/pi/pi_yervoy.pdf

https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-0

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab) This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

EPIDYOLEX® (cannabidiol)

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination

GW Pharmaceuticals receives positive NICE recommendation for EPIDYOLEX® (cannabidiol) oral solution for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy

Sun November 10, 2019 7:01 PM|GlobeNewswire|About: GWPH

GW Pharmaceuticals receives positive NICE recommendation for EPIDYOLEX® (cannabidiol) oral solution for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy November 10, 2019 GW also welcomes the positive guideline recommendation for Sativex® (nabiximols) for the treatment of spasticity due to multiple sclerosis as part of NICE’s evaluation of cannabis-based medicinal products (CBMPs) Cannabidiol oral solution and nabiximols are the first and only plant-derived cannabis-based medicines to be routinely reimbursed on the NHS LONDON and CARLSBAD, Calif., Nov. 10, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH)

Vascepa® (icosapent ethyl)

Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination

ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

REDUCE-IT® USA Results, in Prespecified Subgroup Analyses of Landmark REDUCE-IT Global Study, Showed Robust Cardiovascular Risk Reductions Across a Variety of Study Endpoints, Including Cardiovascular Death and All-Cause Mortality

Mon November 11, 2019 6:30 AM|GlobeNewswire|About: AMRN

Prespecified Analysis of 3,146 Patients in the USA Enrolled in REDUCE-IT Showed 31% Relative Risk Reductions for First Occurrence of Both 5-Point MACE and 3-Point MACE

Significant Reductions Shown in All Predefined Composite and Individual Cardiovascular Endpoints, Including Cardiovascular Death and All-Cause Mortality

Tolerability and Safety Findings Consistent with Full Study

Results Published Today in Circulation and Scheduled for Presentation at American Heart Association 2019 Scientific Sessions on November 17

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.044440

https://amarincorp.com/

https://investor.amarincorp.com/news-releases/news-release-details/reduce-itr-usa-results-prespecified-subgroup-analyses-landmark

VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study Micra™ Transcatheter Pacing

ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections

Mon November 11, 2019 7:30 AM|PR Newswire|About: AGN

PR Newswire

DUBLIN, Nov. 11, 2019 /PRNewswire/ -- Allergan plc (AGN)

https://www.prnewswire.com/news-releases/allergan-receives-fda-qualified-infectious-disease-product-qidp-designation-and-fast-track-designation-for-atm-avi-aztreonam-and-avibactam-for-antibiotic-resistant-gram-negative-infections-300955166.html

https://www.combacte.com/about/about-combacte-care-detail/

ALLERGAN RECEIVES FDA QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) DESIGNATION AND FAST TRACK DESIGNATION FOR ATM-AVI (AZTREONAM AND AVIBACTAM) FOR ANTIBIOTIC-RESISTANT GRAM-NEGATIVE INFECTIONS

Prequel™ Prenatal Screen

MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study Micra™ Transcatheter Pacing

Myriad’s Prequel™ Prenatal Screen Demonstrates High Performance Across All Fetal-Fraction Levels in Women Undergoing Noninvasive Prenatal Screening

Mon November 11, 2019 7:05 AM|GlobeNewswire|About: MYGN

GlobeNewswire

SALT LAKE CITY, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN)

https://obgyn.onlinelibrary.wiley.com/journal/14690705

If you’re pregnant, the Myriad Prequel Prenatal Screen is a noninvasive test that you can take as early as 10 weeks into your pregnancy to learn about your baby’s chance to have a chromosome condition like Down syndrome. The Prequel Prenatal Screen looks at the chances for chromosome conditions, which are usually not inherited, in a current pregnancy. If you are also interested in learning about inherited conditions that you and your partner might pass on to a child, explore more about the Myriad Foresight® Carrier Screen.

MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study Micra™ Transcatheter Pacing

New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker

Mon November 11, 2019 9:00 AM|GlobeNewswire|About: MDT

Data Published in JACC: Clinical Electrophysiology and to be Presented at American Heart Association Scientific Sessions Demonstrates the Potential of Investigational Algorithms in Medtronic Micra Pacemaker to Improve Synchrony and Cardiac Function in AV Block Patients

DUBLIN, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (MDT)

http://newsroom.medtronic.com/news-releases/news-release-details/new-study-shows-promise-treating-more-patients-worlds-smallest

Just Accepted Atrioventricular synchronous pacing using a leadless ventricular pacemaker: Results from the MARVEL 2 study Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, Joseph Yat Sun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence M. Epstein, Jonathan P. Piccini, Mario Pascual, Lluis Mont, Todd Sheldon, Vincent Splett, Kurt Stromberg, Nicole Wood and Larry Chinitz

seeking biotech alpha is biotecMAX 生物技术最大 2/3/2023 the heart of biotech

Seeking Biotech Alpha DECEMBER 2019 Insight

Vicinium®

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Sesen Bio Completes Successful CMC Type B pre-BLA Meeting with FDA

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder

LYNPARZA® (olaparib)

Pozelimab is a VelocImmune®-derived fully-human monoclonal antibody

ambulant diagnostic technology for coagulation testing

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

ambulant diagnostic technology for coagulation testing

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

ambulant diagnostic technology for coagulation testing

Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Bayer enters into collaboration with Children's Hospital of Philadelphia to research novel small molecule therapies for the oral treatment of hemophilia

aducanumab

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Bayer & Children's Hospital of Philadelphia to research small molecule therapies for hemophilia

Biogen's aducanumab showed mixed results in Alzheimer's studies

Seeking Biotech Alpha DECEMBER 2019 Insight

Tecentriq Plus Chemotherapy (Abraxane and Carboplatin)

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Company Investigation Confirms No Asbestos in Johnson's Baby Powder

Reblozyl® (luspatercept-aamt)

Investigation Confirms No Asbestos in Johnson's Baby Powder More Than 150 Tests Show No Asbestos

Reblozyl® (luspatercept-aamt)

Bristol-Myers Squibb and Acceleron Pharma Announce FDA Advisory Committee Will Review Reblozyl® (luspatercept-aamt) for Use in Patients With Myelodysplastic Syndromes

ORENCIA® (abatacept)

ubrogepant 50 mg and 100 mg

Reblozyl® (luspatercept-aamt)

Bristol-Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for ORENCIA® (abatacept) to Help Prevent Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

Tivozanib (FOTIVDA®)

ubrogepant 50 mg and 100 mg

ubrogepant 50 mg and 100 mg

AVEO Oncology Announces Lancet Oncology Publication of Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

ubrogepant 50 mg and 100 mg

ubrogepant 50 mg and 100 mg

ubrogepant 50 mg and 100 mg

Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine

-- Compared to placebo, ubrogepant 50 mg and 100 mg doses led to significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, a new, more stringent FDA standard in the acute treatment of migraine --

-- Ubrogepant 50 mg and 100 mg also met the secondary efficacy endpoint demonstrating clinically significant pain relief at two hours in the majority of patients studied versus placebo, a primary endpoint used in the studies of older migraine treatments, such as triptans --

-- FDA action on New Drug Application (NDA) expected in December 2019 for ubrogepant, which would make it the first oral CGRP blocker (gepant) to address unmet patient needs in acute treatment of migraine --

ALLERGAN ANNOUNCES POSITIVE PHASE 3 ACHIEVE I TRIAL RESULTS FOR UBROGEPANT PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

Seeking Biotech Alpha DECEMBER 2019 Insight

New Data Children's Oncology Trial (AALL1331) of BLINCYTO® (Blinatumomab) vs Chemotherapy

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

Amgen Announces Data Being Presented At ASH 2019

New Data From the Children's Oncology Group Phase 3 Trial (AALL1331) of BLINCYTO® (Blinatumomab) Versus Chemotherapy in First Relapse of Acute Lymphoblastic Leukemia Accepted as Late-Breaking Abstract

Data From Amgen's BiTE® Platform Demonstrate Versatility of Approach Across Four Hematological Malignancies

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

HTX-011 for the management of postoperative pain

BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2

HTX-011 for the management of postoperative pain

Health Canada Grants Priority Review Status for Heron Therapeutics' New Drug Submission for HTX-011 for Management of Postoperative Pain

Heron's HTX-011 nabs accelerated review in Canada for management of postoperative pain

Halcyon™ treatment system

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

HTX-011 for the management of postoperative pain

Varian Further Expands Access to Care in Africa to Address Growing Cancer Burden

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients

Johnson & Johnson Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism; Launching Multi-Center, Post-Market Clinical Trials Across U.S.

-- Two post-market clinical trials initiating across U.S. to demonstrate rotational stability and visual outcomes