biotecMAX™ May/June/July 2020 Insight

https://clinicaltrials.gov/ct2/show/NCT03734588?lead=spark+therapeutics&phase=01&draw=2&rank=2

Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors

Spark Therapeutics Announces Updated Data on SPK-8011 from Phase 1/2 Clinical Trial in Hemophilia A at ISTH 2020 Virtual Congress

Brilacidin’s multiple therapeutic properties – anti-viral SARS-CoV-2 activity,anti-inflammatory

Lumasiran is investigational, subcutaneouslyRNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1)

Innovation Pharmaceuticals – Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted to Commence Q4 2020

Mon July 13, 2020 8:00 AM|GlobeNewswire|About: IPIX

WAKEFIELD, Mass., July 13, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX)

http://www.ipharminc.com/

http://www.ipharminc.com/therapeutic-areas

https://seekingalpha.com/symbol/IPIX

BRILACIDIN

Brilacidin is Innovation's lead drug candidate in its defensin-mimetic franchise.

http://www.ipharminc.com/brilacidin-1

THERAPEUTIC AREAS

Lumasiran is investigational, subcutaneouslyRNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1)

Alnylam Announces that the United Kingdom’s MHRA Grants Early Access to Lumasiran

Mon July 13, 2020 7:28 AM|Business Wire|About: ALNY

– Positive Scientific Opinion Under Early Access to Medicines Scheme (EAMS) Will Make Lumasiran Treatment Available for UK Primary Hyperoxaluria Type 1 (PH1) Patients Before Marketing Authorization --

– Lumasiran Indicated Within EAMS for the Treatment of Patients with PH1 --

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (ALNY)

https://www.alnylam.com/2020/06/07/era-edta-2020/

https://www.businesswire.com/news/home/20200713005319/en/

https://www.alnylam.com/

https://seekingalpha.com/symbol/ALNY

07 Jun, 2020ILLUMINATE-A Phase 3 Results for Lumasiran Presented at ERA-EDTA Positive results from the ILLUMINATE-A Phase 3 study of lumasiran, an investigational RNAi therapeutic in development for the treatment of Primary Hyperoxaluria Type 1 (PH1), were presented by study investigators at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) International Congress, held June 6-9, 2020 as a virtual event.

Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

Lumasiran is investigational, subcutaneouslyRNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1)

Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

Mon July 13, 2020 6:45 AM|Business Wire|About: BNTX, PFE

Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc (PFE). (NYSE: PFE) and BioNTech SE (BNTX) (Nasdaq: BNTX, “BioNTech”)

https://biontech.de/

https://www.businesswire.com/news/home/20200713005168/en/

https://www.pfizer.de/

https://seekingalpha.com/symbol/BNTX

Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

coronavirus vaccine

Lumasiran is investigational, subcutaneouslyRNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1)

Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2

IDEAS

COVID-19

Pfizer CEO Albert Bourla Raises Expectations That the Pharmaceutical Giant Can Deliver a COVID-19 Vaccine by Fall

BY EBEN SHAPIRO

UPDATED: JULY 12, 2020 7:07 AM EDT | ORIGINALLY PUBLISHED: JULY 9, 2020 11:26 AM EDT

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0

PFIZER AND BIONTECH ANNOUNCE EARLY POSITIVE DATA FROM AN ONGOING PHASE 1/2 STUDY OF MRNA-BASED VACCINE CANDIDATE AGAINST SARS-COV-2

Wednesday, July 01, 2020 - 08:59amEST

biotecMAX™ May/June/July 2020 Insight

KSI-301 Patients w/ Wet Age-Related Macular Degeneration, Diabetic Macular Edema/ Retinal Vein Occlu

Kodiak Sciences Announces New Longer-Term Safety, Efficacy and Durability Data from Ongoing Phase 1b Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting

Fri July 10, 2020 4:00 PM|PR Newswire|About: KOD

- 82% of wet AMD eyes extended to 4-months or longer before first retreatment, with 68% achieving a six-month treatment-free interval

- 76% of DME eyes extended to four-months or longer and 67% extended to 6-months or longer before first retreatment, with nearly half of DME eyes yet to require any retreatment following the loading phase

- Mean of 1.3, 0.6, and 1.3 retreatments administered in the eight months following the loading phase in the wAMD, DME, and RVO patients, respectively

- Encouraging safety profile maintained after 546 doses in 130 patients, with over 150 patient-years of clinical safety data across the KSI-301 development program

PR Newswire

PALO ALTO, Calif., July 10, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (KOD)

https://kodiak.com/

https://kodiak.com/our-pipeline/

https://ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-announces-new-longer-term-safety-efficacy-and

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (DAZZLE)

https://clinicaltrials.gov/ct2/show/NCT04049266

https://www.prnewswire.com/news-releases/kodiak-sciences-announces-new-longer-term-safety-efficacy-and-durability-data-from-ongoing-phase-1b-study-of-ksi-301-in-patients-with-wet-age-related-macular-degeneration-diabetic-macular-edema-and-retinal-vein-occlusion-at-the--301091706.html

https://seekingalpha.com/symbol/KOD

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (DAZZLE)

https://clinicaltrials.gov/ct2/show/NCT04049266?lead=kodiak+sciences&draw=2&rank=1

Inspired to build the world's leading high-science retina pipeline

SARCLISA™ (isatuximab for injection)

KSI-301 Patients w/ Wet Age-Related Macular Degeneration, Diabetic Macular Edema/ Retinal Vein Occlu

SARCLISA™ (isatuximab for injection) now available in Canada for patients with relapsed and refractory multiple myeloma

Wed July 8, 2020 7:15 AM|Canada Newswire

First and only anti-CD38 antibody in combination with pomalidomide and dexamethasone (pom-dex) to be approved in Canada1,2
SARCLISA™ in combination with pom-dex significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial2
Multiple myeloma is the third most common blood cancer in Canada3

MISSISSAUGA, ON, July 8, 2020 /CNW/ - Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA™ in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.2

https://www.sarclisa.com/

https://seekingalpha.com/symbol/SNY

SARCLISA™ (isatuximab for injection) now available in Canada for patients with relapsed and refractory multiple myeloma

http://sanoficanada.mediaroom.com/2020-07-08-SARCLISA-TM-isatuximab-for-injection-now-available-in-Canada-for-patients-with-relapsed-and-refractory-multiple-myeloma

SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma. Proteasome inhibitors include medicines such as Kyprolis® (carfilzomib), Ninlaro® (ixazomib), and Velcade® (bortezomib).

remdesivir (GS-5734™)

KSI-301 Patients w/ Wet Age-Related Macular Degeneration, Diabetic Macular Edema/ Retinal Vein Occlu

remdesivir (GS-5734™)

Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19

Foster City, Calif., July 8, 2020 – Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:

Gilead launches early-stage study of inhaled remdesivir

https://seekingalpha.com/news/3589630-gilead-launches-early-stage-study-of-inhaled-remdesivir

https://www.gilead.com/

https://www.gilead.com/science-and-medicine/pipeline

July 10, 2020 Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19 -- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care -- -- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)

finerenone

BOTOX® (onabotulinumtoxinA)

remdesivir (GS-5734™)

Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

Finerenone reduced the combined primary endpoint of risk of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care
Approximately twenty-nine million Americans have type 2 diabetes, and about forty percent of patients with type 2 diabetes will develop chronic kidney disease, a deadly, underrecognized condition1,2
Finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate risk reduction in renal and cardiovascular events in patients with chronic kidney disease and type 2 diabetes

July 09, 2020 07:00 AM Eastern Daylight Time

WHIPPANY, N.J.--(BUSINESS WIRE)-

https://www.bayer.com/

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

https://clinicaltrials.gov/ct2/show/NCT02540993?term=fidelio-dkd&draw=2&rank=1

https://seekingalpha.com/symbol/BAYRY

Bayer's finerenone successful in late-stage study in T2D patients with kidney disease Jul. 9, 2020 11:21 AM ET|About: Bayer Aktiengesellschaft (BAYRY)|By: Douglas W. House, SA News Editor

BOTOX® (onabotulinumtoxinA)

FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity

Thu July 9, 2020 6:32 PM|PR Newswire|About: ABBVPR Newswire

NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ -- Allergan, an AbbVie (ABBV) company, today announced that the U.S. Food and Drug Administration (FDA)

Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

https://www.abbvie.com/

https://www.prnewswire.com/news-releases/fda-approves-expanded-botox-onabotulinumtoxina-label-for-the-treatment-of-pediatric-patients-with-spasticity-301091264.html

https://www.botoxmedical.com/

https://seekingalpha.com/symbol/ABBV

Veklury (remdesivir)

BOTOX® (onabotulinumtoxinA)

Australia's first COVID treatment approved

10 July 2020

The Therapeutic Goods Administration (TGA) has granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19. It has received provisional approval for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.

Gilead's remdesivir OK'd in Australia for COVID-19

Jul. 10, 2020 7:26 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3590149-gileads-remdesivir-okd-in-australia-for-covidminus-19

https://seekingalpha.com/news/3573501-gilead-inks-deals-to-sell-remdesivir-in-127-countries

Gilead inks deals to sell remdesivir in 127 countries

May 12, 2020 2:14 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor

https://www.gilead.com/purpose/advancing-global-health/covid-19

Remdesivir Emergency Use

https://www.gilead.com/remdesivir

Australia's first COVID treatment approved

https://www.tga.gov.au/media-release/australias-first-covid-treatment-approved

About Remdesivir

https://www.gilead.com/purpose/advancing-global-health/covid-19/about-remdesivir

July 10, 2020

Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19

-- Data Presented Includes a Comparative Analysis of Clinical Recovery and Mortality Outcomes from the Phase 3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients Receiving Standard of Care --

-- Traditionally Marginalized Racial/Ethnic Groups Treated with Remdesivir Had Similar Clinical Outcomes as Overall Patient Population --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-presents-additional-data-on-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19

About Remdesivir

KEYTRUDA® (pembrolizumab)

BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Thu July 9, 2020 6:45 AM|Business Wire|About: MRK

Application Based on Data Comparing KEYTRUDA to Standard of Care (Brentuximab Vedotin) From Pivotal Phase 3 KEYNOTE-204 Trial

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)

https://clinicaltrials.gov/ct2/show/NCT02684292

https://www.businesswire.com/news/home/20200709005215/en/

https://www.mrknewsroom.com/newsroom/news-releases/news-details/2020/FDA-Grants-Priority-Review-to-Mercks-Supplemental-Biologics-License-Application-for-KEYTRUDA-pembrolizumab-for-Second-Line-Treatment-of-Patients-With-Relapsed-or-Refractory-Classical-Hodgkin-Lymphoma/default.aspx

https://www.merck.com/index.html

https://www.keytruda.com/

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER IT’S TRU. KEYTRUDA.

BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

BRILINTA Granted FDA Priority Review for the Reduction of Subsequent Stroke in Patients Who Had an Acute Ischemic Stroke or Transient Ischemic Attack

Thu July 9, 2020 7:00 AM|Business Wire|About: AZN

BRILINTA in combination with aspirin could be the first FDA-approved dual antiplatelet therapy to reduce the rate of stroke in these high-risk patients

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

BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

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

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

https://www.businesswire.com/news/home/20200709005235/en/

Brilinta granted FDA Priority Review for the reduction of subsequent stroke in patients who had an acute ischemic stroke or transient ischemic attack

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/brilinta-granted-fda-priority-review-for-the-reduction-of-subsequent-stroke-in-patients-who-had-an-acute-ischemic-stroke-or-transient-ischemic-attack.html

https://seekingalpha.com/symbol/AZN

INDICATIONS BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Lynparza (olaparib)

BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

aducanumab for Alzheimer's disease (AD)

Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

PUBLISHED8 July 2020

8 July 2020 07:00 BST

Only PARP inhibitor approved in this disease

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc

Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer

https://www.nejm.org/doi/full/10.1056/NEJMoa1903387

https://www.lynparza.com/

AstraZeneca's Lynparza OK'd in Europe for BRCA+ pancreatic cancer

Jul. 8, 2020 6:50 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3589368-astrazenecas-lynparza-okd-in-europe-for-brca-pancreatic-cancer

https://seekingalpha.com/symbol/AZN

https://www.astrazeneca.com/

WHAT IS LYNPARZA? 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 alone 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 advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, 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 a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you

aducanumab for Alzheimer's disease (AD)

Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]

aducanumab for Alzheimer's disease (AD)

Biogen completes U.S. application for Alzheimer's drug aducanumab

Jul. 8, 2020 7:49 AM ET|About: Biogen Inc. (BIIB)|By: Douglas W. House, SA News Editor

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE)

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

BIOGEN COMPLETES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER’S DISEASE

July 8, 2020 at 7:30 AM EDT

https://investors.biogen.com/news-releases/news-release-details/biogen-completes-submission-biologics-license-application-fda

https://seekingalpha.com/symbol/BIIB

Biogen Plans Regulatory Filing for aducanumab in Early Alzheimer’s Disease

Brilacidin is a unique 3-in-1 antiviral, anti-inflammatory, antimicrobial COVID-19 drug candidate

Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]

In Vitro Testing of Innovation Pharmaceuticals’ Brilacidin for COVID-19 Shows Consistent Anti-SARS-CoV-2 Efficacy; Manufacturing Preparation Underway for COVID-19 Clinical Trial

Tue July 7, 2020 8:00 AM|GlobeNewswire|About: IPIXGlobeNewswire

WAKEFIELD, Mass., July 07, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (IPIX)

http://www.ipharminc.com/brilacidin-1

www.IPharmInc.com.

https://seekingalpha.com/symbol/IPIX

Innovation Pharmaceuticals’ Brilacidin Inhibits SARS-CoV-2 (COVID-19) by 97 Percent in a Human Lung Cell Line

Brilacidin

Data from Ongoing Testing at U.S. Regional Biocontainment Laboratory

· Data adds to growing body of research in both human and animal cell lines supporting Brilacidin’s robust antiviral properties against SARS-CoV-2

· Brilacidin is a unique 3-in-1 antiviral, anti-inflammatory, antimicrobial COVID-19 drug candidate

WAKEFIELD, MA – June 17, 2020 (GLOBE NEWSWIRE)

http://www.ipharminc.com/press-release/2020/6/17/innovation-pharmaceuticals-brilacidin-inhibits-sars-cov-2-covid-19-by-97-percent-in-a-human-lung-cell-line

BRILACIDIN Brilacidin is Innovation's lead drug candidate in its defensin-mimetic franchise.

Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]

Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU

Jul 07, 2020

European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1*
Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by EC approval
Approval based on robust efficacy and safety data from the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was superior to once-daily Atectura® Breezhaler® (IND/MF) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment2
Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health and financial burden when not adequately controlled3,4

Basel, July 7, 2020

https://www.novartis.com.

Novartis' Enerzair Breezhaler OK'd in Europe for uncontrolled asthma

Jul. 7, 2020 1:11 PM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3589196-novartis-enerzair-breezhaler-okd-in-europe-for-uncontrolled-asthma

https://seekingalpha.com/symbol/NVS

https://www.novartis.com/search-results?query=Enerzair+Breezhaler

JULY 7, 2020 / 1:20 AM / UPDATED 12 HOURS AGO BRIEF-Novartis Gets European Commission Approval For Enerzair Breezhaler Asthma Treatment 1 MIN READ July 7 (Reuters) - Novartis AG:

biotecMAX™ May/June/July 2020 Insight

MiniMed™ Mio™ Advance infusion set to all Medtronic insulin pump customers

Medtronic Introduces MiniMed™ Mio™ Advance Infusion Set Enabling Fewer Insertion Steps for People with Diabetes in the U.S.

Tue July 7, 2020 9:00 AM|GlobeNewswire|About: MDT

DUBLIN, July 07, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (MDT) (NYSE:MDT)

https://www.medtronic.com/us-en/index.html

https://www.medtronicdiabetes.com/home

https://www.medtronicdiabetes.com/search?cq=MiniMed%E2%84%A2+Mio%E2%84%A2+Advance+infusion+se

http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-introduces-minimedtm-miotm-advance-infusion-set

https://seekingalpha.com/symbol/MDT

The MiniMed™ Mio™ Advance is our newest infusion set. This infusion set has a 90°, soft cannula and can be inserted with only 4 steps. The all-in-one insertion design means that no separate serter is needed. The MiniMed™ Mio™ Advance infusion set can be inserted with one hand (left or right) and has a hidden needle throughout insertion.

NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate

MiniMed™ Mio™ Advance infusion set to all Medtronic insulin pump customers

U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine

The Maryland-based company, which has never brought a product to market before, just made the biggest deal to date with the Trump administration’s Operation Warp Speed.

By Katie Thomas

July 7, 2020, 6:00 a.m. ET

Novavax Announces $1.6 Billion Funding from Operation Warp Speed

Tue July 7, 2020 6:00 AM|GlobeNewswire|About: NVAX

Funding supports late-stage clinical development, including pivotal Phase 3 clinical trial to support licensure
OWS award funds large-scale manufacturing of NVX-CoV2373, including production of 100 million doses starting in late 2020

GAITHERSBURG, Md., July 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX)

https://seekingalpha.com/pr/17922788-novavax-announces-1_6-billion-funding-from-operation-warp-speed

https://novavax.com/

https://novavax.com/our-pipeline#nvx-cov2373

https://seekingalpha.com/symbol/NVAX

We have successfully produced NVX-CoV2373, a vaccine candidate that is designed to provide protection against COVID-19. Engineered from the genetic sequence of COVID-19, we used our recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. In combination with our proprietary Matrix-M™ adjuvant, NVX-CoV2373 has demonstrated in preclinical studies that it binds efficiently with human receptors targeted by the virus, a critical aspect for effective vaccine protection.

HEPANOVA

MiniMed™ Mio™ Advance infusion set to all Medtronic insulin pump customers

Yselty® (linzagolix)

Novocure Enrolls Last Patient in HEPANOVA Trial Testing Tumor Treating Fields in Combination with Sorafenib in Advanced Liver Cancer

Tue July 7, 2020 7:30 AM|Business Wire|About: NVCR

Final data collection will occur in six months

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NVCR)

https://www.businesswire.com/news/home/20200707005186/en/

https://www.novocure.com/

https://www.novocure.com/our-pipeline/

https://seekingalpha.com/symbol/NVCR

https://www.novocure.com/novocure-enrolls-last-patient-in-hepanova-trial-testing-tumor-treating-fields-in-combination-with-sorafenib-in-advanced-liver-cancer/

The science of Tumor Treating Fields has the potential to extend beyond glioblastoma. Tumor Treating Fields has shown a consistent anti-mitotic effect in our preclinical and clinical research over the last 19 years.

Yselty® (linzagolix)

Gallant implantable cardioverter defibrillator (ICD) & cardiac resynchronization defibrillator (CRT)

Yselty® (linzagolix)

ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty® (linzagolix) for the Treatment of Uterine Fibroids

Mon July 6, 2020 1:00 AM|GlobeNewswire|About: OBSV

PRIMROSE 1 achieved statistically significant and clinically meaningful results across primary and key secondary endpoints at week 24
PRIMROSE 2 results demonstrate sustained efficacy and continued safety of linzagolix at week 52
Results confirm linzagolix as a potential best-in-class GnRH antagonist, with a pooled responder rate of 84.7% for the 200 mg with Add Back Therapy* (ABT) dose from PRIMROSE 1 and 2
Linzagolix is the only GnRH antagonist as a potential unique treatment option for up to 50% of US women with uterine fibroids for whom ABT therapy may be contraindicated
Success of PRIMROSE 1 and 2 studies enables progression towards regulatory submissions, anticipated 4Q 2020 in the EU and 1H 2021 in the US

GENEVA, Switzerland and BOSTON, MA (July 6, 2020) – ObsEva SA (OBSV),

https://www.obseva.com/

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 1)

https://clinicaltrials.gov/ct2/show/NCT03070899?spons=obseva&draw=2&rank=11

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 2)

https://clinicaltrials.gov/ct2/show/NCT03070951?spons=obseva&draw=2&rank=10

https://seekingalpha.com/symbol/OBSV

https://www.obseva.com/our-pipeline-overview/

ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty® (linzagolix) for the Treatment of Uterine Fibroids

Trodelvy (sacituzumab govitecan-hziy)

Gallant implantable cardioverter defibrillator (ICD) & cardiac resynchronization defibrillator (CRT)

Immunomedics Announces Positive Results from Phase 3 ASCENT Study of TRODELVY™ in Previously-Treated Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Mon July 6, 2020 7:55 AM|GlobeNewswire|About: IMMU

Trodelvy significantly improved progression-free survival (PFS) and overall survival (OS) in previously-treated brain metastasis negative patients with advanced mTNBC

The safety profile of Trodelvy was consistent with the FDA-approved label and no new safety signals were observed

Trodelvy is the first antibody-drug conjugate (ADC) shown to improve clinical outcomes in people with relapsed or refractory mTNBC who have received two prior therapies

sBLA submission seeking full approval planned for later this year

Company to host conference call and webcast today at 8:00 a.m. Eastern Time

MORRIS PLAINS, N.J., July 06, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU) (NASDAQ: IMMU)

https://www.immunomedics.com/

https://www.immunomedics.com/our-company/news-and-events/immunomedics-announces-positive-results-from-phase-3-ascent-study-of-trodelvytm/

ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT)

https://clinicaltrials.gov/ct2/show/NCT02574455

https://www.trodelvy.com/patient

https://seekingalpha.com/symbol/IMMU

INDICATION TRODELVY is a prescription medicine used to treat adults with breast cancer that is estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer), and that has spread to other parts of the body (metastatic), and who previously received at least two therapies for metastatic disease. TRODELVY is approved based on tumor response. Data are not yet available to show if TRODELVY improves survival or symptoms.

Gallant implantable cardioverter defibrillator (ICD) & cardiac resynchronization defibrillator (CRT)

Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring

Mon July 6, 2020 7:30 AM|PR Newswire|About: ABT

- Gallant ICD and CRT-D devices feature a patient-preferred design without compromising on battery longevity and compatibility with magnetic resonance imaging (MRI)

PR Newswire

ABBOTT PARK, Ill., July 6, 2020 /PRNewswire/ -- Abbott (ABT)

The Gallant system received CE Mark for use across Europe earlier this year.

For important safety information, please visit abbott.com.

https://www.abbott.com/

FDA OKs Abbott's next-gen defibrillators

Jul. 6, 2020 8:25 AM ET|About: Abbott Laboratories (ABT)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/symbol/ABT

https://www.abbott.com/consumer/cardiovascular.html

https://seekingalpha.com/news/3588661-fda-oks-abbotts-next-gen-defibrillators

ABBOTT INTRODUCES NEXT-GENERATION HEART RHYTHM MANAGEMENT DEVICES IN EUROPE, FEATURING STATE-OF-THE-ART PATIENT APP AND BLUETOOTH CONNECTIVITY

- New Gallant™ high voltage devices offer patients and their doctors a smartphone app and Bluetooth connectivity designed to help doctors tailor therapy to a patient's unique clinical needs

- Gallant ICD and CRT-D devices feature a more comfortable design, preferred by patients without compromising on battery longevity or high-voltage output, which remain among the highest in the industry

https://abbott.mediaroom.com/2020-02-18-Abbott-Introduces-Next-Generation-Heart-Rhythm-Management-Devices-in-Europe-Featuring-State-of-the-Art-Patient-App-and-Bluetooth-Connectivity

CARDIOVASCULAR LIFE-CHANGING MEDICAL DEVICE TECHNOLOGIES AND SOLUTIONS THAT TREAT CARDIOVASCULAR CONDITIONS.

REGN-COV2

Glaxo, Sanofi near £500M COVID-19 vaccine deal with the U.K

remdesivir 100 mg/vial

Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Mon July 6, 2020 7:00 AM|PR Newswire|About: REGNPR Newswire

TARRYTOWN, N.Y., July 6, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN)

https://www.biorxiv.org/content/10.1101/2020.07.04.187757v1

https://www.regeneron.com/

https://www.prnewswire.com/news-releases/regeneron-announces-start-of-regn-cov2-phase-3-covid-19-prevention-trial-in-collaboration-with-national-institute-of-allergy-and-infectious-diseases-niaid-301088202.html

https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-start-regn-cov2-phase-3-covid-19-prevention

Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

https://clinicaltrials.gov/ct2/show/NCT04452318?cond=COVID&spons=regeneron&phase=12&draw=2&rank=4

Phase 2/3 portion of two adaptive Phase 1/2/3 trials assessing the cocktail in hospitalized and non-hospitalized COVID-19 patients.

https://seekingalpha.com/symbol/REGN

TWO SCIENCE PUBLICATIONS HIGHLIGHT POTENTIAL OF REGN-COV2 ANTI-VIRAL ANTIBODY COCKTAIL TO PROTECT AGAINST SARS-COV-2 ESCAPE MUTANTS TARRYTOWN, N.Y., June 11, 2020 /PRNewswire/ -- Regeneron utilized 'rapid response' VelociSuite® technologies to identify pairs of potent and complementary antibodies that could be combined into antibody 'cocktails' for COVID-19 Cocktail approach protects against viral mutants by requiring simultaneous mutation at multiple genetic positions for viral escape Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

remdesivir 100 mg/vial

Glaxo, Sanofi near £500M COVID-19 vaccine deal with the U.K

remdesivir 100 mg/vial

Remdesivir OK'd in India for COVID-19

Jul. 6, 2020 6:27 AM ET|About: Mylan, Inc. (MYL)|By: Douglas W. House, SA News Editor

Gilead Sciences (NASDAQ:GILD) licensee Mylan N.V. (NASDAQ:MYL)

Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection 100 mg/vial in India for Restricted Emergency Use in COVID-19 Patients

Mon July 6, 2020 6:00 AM|PR Newswire|About: MYL

HERTFORDSHIRE, England and PITTSBURGH and BANGALORE, India, July 6, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL)

https://seekingalpha.com/pr/17921459-mylan-secures-regulatory-approval-for-remdesivir-lyophilized-powder-for-injection-100-mg-vial

https://www.prnewswire.com/news-releases/mylan-secures-regulatory-approval-for-remdesivir-lyophilized-powder-for-injection-100-mgvial-in-india-for-restricted-emergency-use-in-covid-19-patients-301088240.html

https://seekingalpha.com/symbol/MYL

https://www.remdesivir.com/us/?gclid=Cj0KCQjwl4v4BRDaARIsAFjATPlbHCXHvkpITfkUFfC5yDpJQa5fSgYX_6rTpWneZSpDZKE2gK9xWBUaAnbFEALw_wcB&gclsrc=aw.ds

https://www.gilead.com/purpose/advancing-global-health/covid-19/about-remdesivir

https://www.gilead.com/

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of remdesivir to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19. Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19. The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens.

Glaxo, Sanofi near £500M COVID-19 vaccine deal with the U.K

Glaxo Smith Kline nears £500m UK coronavirus vaccine deal

Drugs giant in talks to sell 60m doses to the government

Glaxo, Sanofi near £500M COVID-19 vaccine deal with the U.K.

Jul. 5, 2020 4:06 AM ET|About: Sanofi (SNY)|By: Yoel Minkoff, SA News Editor

https://seekingalpha.com/news/3588561-glaxo-sanofi-near-500m-covidminus-19-vaccine-deal-u-k

https://seekingalpha.com/symbol/GSK

https://www.gsk.com/en-gb/

https://seekingalpha.com/symbol/SNY

https://www.sanofi.com/en

Our vaccines business develops, produces and distributes over 1.9 million vaccines every day to people across over 150 countries.

imlifidase

Veklury® (remdesivir)

Glaxo, Sanofi near £500M COVID-19 vaccine deal with the U.K

Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase

Thu July 2, 2020 7:00 AM|GlobeNewswire|About: SRPT

-- Exclusive worldwide license enables Sarepta to develop and promote imlifidase as a pre-treatment for gene therapy in Duchenne and Limb-girdle muscular dystrophy patients who have pre-existing antibodies to AAV --

CAMBRIDGE, Mass., July 02, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT

https://www.sarepta.com/

imlifidase

https://hansabiopharma.com/

https://seekingalpha.com/symbol/HNSBF

https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-signs-agreement-hansa-biopharma-imlifidase

https://seekingalpha.com/symbol/SRPT

Imlifidase Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.

Veklury® (remdesivir)

European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19

Fri July 3, 2020 7:56 AM|Business Wire|About: GILD

-- Veklury is the First Approved Treatment Option for COVID-19 in the European Union --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

https://www.gilead.com/remdesivir

https://www.gilead.com/

https://www.businesswire.com/news/home/20200703005116/en/

https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/european-commission-grants-conditional-marketing-authorization-for-gileads-veklury-remdesivir-for-the-treatment-of-covid19

https://www.businesswire.com/news/home/20200702005580/en/

Remdesivir Emergency Use

Rukobia (fostemsavir)

Veklury® (remdesivir)

ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available

Thu July 2, 2020 4:48 PM|Business Wire|About: GSK, PFE

In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need

LONDON--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. (PFE) and Shionogi Limited

02 July 2020

ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available

https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-for-rukobia-fostemsavir-a-first-in-class-treatment-for-hiv-in-adults-with-few-treatment-options-available/

https://www.gsk.com/en-gb/

https://viivhealthcare.com/en-us/

https://www.viivconnect.com/

https://seekingalpha.com/symbol/GSK

https://seekingalpha.com/news/3588489-fda-oks-viiv-healthcares-fostemsavir-for-hivminus-1

Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.

biotecMAX™ May/June 2020 Insight

Reblozyl (luspatercept)

ENSPRYNG®️ (satralizumab)

ULTOMIRIS® (ravulizumab)

European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia

Fri June 26, 2020 9:05 AM|Business Wire|About: BMY, XLRN

Reblozyl regulates late-stage red blood cell (RBC) maturation to potentially reduce or eliminate the need for regular RBC transfusions

Reblozyl is the first and only erythroid maturation agent to be approved in the European Union, representing a new class of therapy

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

https://www.bms.com/

http://acceleronpharma.com/

Please see full Prescribing Information and Summary of Product Characteristics for REBLOZYL

https://www.businesswire.com/news/home/20200626005247/en/

https://seekingalpha.com/symbol/BMY

https://seekingalpha.com/symbol/XLRN

Luspatercept-aamt Novel erythroid maturation agent in development for treatment of serious and chronic anemias

ULTOMIRIS® (ravulizumab)

ENSPRYNG®️ (satralizumab)

ULTOMIRIS® (ravulizumab)

ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults and Children with Atypical Hemolytic Uremic Syndrome (aHUS)

Mon June 29, 2020 2:00 AM|Business Wire|About: ALXN

– ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS, administered every other month, reducing the treatment burden for adults and children –

– ULTOMIRIS has the potential to become the new standard of care in Europe for the treatment of aHUS –

– aHUS is an ultra-rare disease which may progressively damage the kidney and other organs1,2 –

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

https://alexion.com/

Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS,

https://www.businesswire.com/news/home/20200628005036/en/

https://www.ultomiris.com/

https://ir.alexion.com/news-releases/news-release-details/ultomirisr-ravulizumab-receives-marketing-authorization-0

https://seekingalpha.com/symbol/ALXN

https://seekingalpha.com/news/3586749-alexion-pharmas-ultomiris-okd-in-europe

What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat: adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). It is not known if ULTOMIRIS is safe and effective in children with PNH.

ENSPRYNG®️ (satralizumab)

ARCALYST® (rilonacept) INJECTION

Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder

ENSPRYNG is Japan’s first and only approved therapy for both adults and children with neuromyelitis optica spectrum disorder (NMOSD)
ENSPRYNG is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks
Approval is supported by data demonstrating ENSPRYNG’s robust efficacy, which was well-tolerated with a consistent safety profile, in a broad NMOSD population as a monotherapy and as an add-on therapy
Asia has a high prevalence of NMOSD with limited treatment options

Basel, 29 June 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)

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

https://www.roche.com/

https://rarediseases.org/rare-diseases/neuromyelitis-optica/

Roche's satralizumab OK'd in Japan for rare optic nerve inflammation disorder Jun. 29, 2020 6:48 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

ARCALYST® (rilonacept) INJECTION

Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection

ARCALYST® (rilonacept) INJECTION

Kiniksa Announces Positive Data from Phase 3 Trial of Rilonacept in Recurrent Pericarditis (RHAPSODY)

Mon June 29, 2020 7:15 AM|GlobeNewswire|About: KNSA

Primary and all major secondary efficacy endpoints were highly statistically significant
Rilonacept treatment resulted in a 96% reduction in risk of recurrent pericarditis events (primary efficacy endpoint: Hazard Ratio = 0.04, p<0.0001)
Safety results consistent with FDA-approved label for CAPS
sBLA submission expected later this year
Conference call and webcast scheduled for 8:30 a.m. EDT today

HAMILTON, Bermuda, June 29, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (KNSA) (Nasdaq: KNSA)

RHAPSODY Phase 3 Study to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis (RHAPSODY)

https://clinicaltrials.gov/ct2/show/NCT03737110?titles=rhapsody&lead=kiniksa&phase=2&draw=1&rank=1

https://www.kiniksa.com/

https://www.regeneron.com/arcalyst-injection

Kiniksa's rilonacept successful in pivotal heart inflammation study

Jun. 29, 2020 8:05 AM ET|About: Kiniksa Pharmaceutical... (KNSA)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3586834-kiniksas-rilonacept-successful-in-pivotal-heart-inflammation-study

Rilonacept

Phase 3

https://seekingalpha.com/symbol/KNSA https://www.kiniksa.com/our-pipeline/rilonacept/

What is Pericarditis?

https://www.heart.org/en/health-topics/pericarditis/what-is-pericarditis#:~:text=Pericarditis%20refers%20to%20inflammation%20of,there

https://seekingalpha.com/symbol/REGN

Indication ARCALYST® (rilonacept) Injection for Subcutaneous Use is used to treat adults and children 12 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection

FDA NEWS RELEASE

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

https://www.gene.com/

https://www.gene.com/media/press-releases/14859/2020-06-29/fda-approves-genentechs-phesgo-fixed-dos

PHESGO™ (PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF)

https://www.gene.com/patients/medicines/phesgo

FDA OKs Roche combo injection for type of breast cancer

Jun. 29, 2020 12:31 PM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3586991-fda-oks-roche-combo-injection-for-type-of-breast-cancer

https://seekingalpha.com/symbol/RHHBY

https://www.herceptin.com/

https://www.perjeta.com/

Monday, Jun 29, 2020 FDA Approves Genentech’s Phesgo (Fixed-Dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-Positive Breast Cancer Phesgo offers faster administration of Perjeta and Herceptin under the skin in just minutes, compared to hours with standard intravenous administration Data showed that 85% of patients preferred Phesgo compared to standard intravenous administration South San Francisco, CA -- June 29, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),

Keytruda (pembrolizumab)

Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

Mon June 29, 2020 3:33 PM|PR Newswire

SILVER SPRING, Md., June 29, 2020 /PRNewswire/ --

https://www.prnewswire.com/news-releases/fda-approves-first-line-immunotherapy-for-patients-with-msi-hdmmr-metastatic-colorectal-cancer-301085293.html

FDA OKs Merck's Keytruda for highly mutating forms of colorectal cancer

Jun. 29, 2020 3:57 PM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3587077-fda-oks-mercks-keytruda-for-highly-mutating-forms-of-colorectal-cancer

https://www.keytruda.com/

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Tisotumab Vedotin

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

Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Mon June 29, 2020 4:30 PM|Business Wire|About: SGEN

- Full Data to be Presented at an Upcoming Medical Meeting -

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

A Trial of Tisotumab Vedotin in Cervical Cancer

https://clinicaltrials.gov/ct2/show/NCT03438396?term=NCT03438396

https://www.genmab.com/

https://www.genmab.com/pipeline/#page-products

https://www.seattlegenetics.com/

https://www.businesswire.com/news/home/20200629005802/en/

https://seekingalpha.com/symbol/SGEN

https://seekingalpha.com/symbol/GMAB

Genmab proprietary products† Partnership: Seattle Genetics, Inc. Target: Tissue Factor Cervical cancer: Phase 2

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

Vertex Announces Expansion of Reimbursement Agreement With NHS England to Include KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO® (ivacaftor)

Tue June 30, 2020 8:34 AM|Business Wire|About: VRTX

-CF patients in England will be among the first in Europe to benefit from access to KAFTRIO®, if the medicine is approved by the European Commission-

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

https://www.vrtx.com/

https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-expansion-reimbursement-agreement-nhs-england

https://www.businesswire.com/news/home/20200630005573/en/

https://www.kalydeco.com/

https://cysticfibrosisnewstoday.com/2020/06/29/chmp-gives-positive-opinion-to-vertexs-triple-combination-therapy/

https://www.vrtx.com/cystic-fibrosis/cf-community-grant-programs/

https://pipelinereview.com/index.php/2020062875145/Small-Molecules/CHMP-Grants-Positive-Opinion-for-KAFTRIO-ivacaftor/tezacaftor/elexacaftor-in-Combination-With-KALYDECO-ivacaftor-in-People-Ages-12-and-Older-With-Cystic-Fibrosis-With-the.html

https://seekingalpha.com/symbol/VRTX

What is KALYDECO® (ivacaftor)? KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Talk to your doctor to learn if you have an indicated CF gene mutation.

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

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

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Exelixis Announces Initiation of CONTACT-02 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Castration-Resistant Prostate Cancer

Tue June 30, 2020 8:00 AM|Business Wire|About: EXEL

– Initiation follows positive results from cohort 6 of phase 1b COSMIC-021 trial –

– CONTACT-02 is the second of three phase 3 pivotal trials that are part of a clinical collaboration with Roche –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC (CONTACT-02)

Sponsor:

Exelixis

Collaborators:

Roche-Genentech

Takeda

https://clinicaltrials.gov/ct2/show/NCT04446117?term=CONTACT+02&draw=2&rank=1

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

https://www.exelixis.com/

https://www.businesswire.com/news/home/20200630005244/en/

https://www.cabometyx.com/

https://seekingalpha.com/symbol/EXEL

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-initiation-contact-02-phase-3-pivotal-trial

https://seekingalpha.com/news/3587392-exelixis-launches-late-stage-study-of-cabozantinib-combo-in-prostate-cancer

What is CABOMETYX? CABOMETYX is a prescription medicine used to treat people with: Advanced kidney cancer (renal cell carcinoma) Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

Dupixent® (dupilumab)

anti-PD-1 antibody tislelizumab in combination with chemotherapy

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Dupixent® (dupilumab) Approved in China for Adults with Moderate-to-Severe Atopic Dermatitis

Fri June 19, 2020 7:30 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, June 19, 2020 /PRNewswire/ --

Dupixent included in list of overseas approved drugs that meet urgent clinical need in China

Dupixent is approved in 60 countries for adults with moderate-to-severe atopic dermatitis, one of the diseases driven by type 2 inflammation

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi

Please see full Prescribing Information including Patient Information.

https://www.regeneron.com/

https://seekingalpha.com/symbol/REGN

https://www.sanofi.com/

https://seekingalpha.com/symbol/SNY

https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-china-adults-moderate-severe-atopic

https://www.prnewswire.com/news-releases/dupixent-dupilumab-approved-in-china-for-adults-with-moderate-to-severe-atopic-dermatitis-301080239.html

https://www.dupixent.com/

Indications DUPIXENT is a prescription medicine used: to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

anti-PD-1 antibody tislelizumab in combination with chemotherapy

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Non-Squamous Non-Small Cell Lung Cancer in China

Fri June 19, 2020 12:27 AM|GlobeNewswire|About: BGNE

BEIJING, China and CAMBRIDGE, Mass., June 19, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.beigene.com/

BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Non-Squamous Non-Small Cell Lung Cancer in China

June 19, 2020 at 12:27 AM EDT

BEIJING, China and CAMBRIDGE, Mass., June 19, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-2

https://seekingalpha.com/symbol/BGNE

Tislelizumab Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Crysvita (burosumab-twza) injection

anti-PD-1 antibody tislelizumab in combination with chemotherapy

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

Thu June 18, 2020 1:45 PM|PR Newswire

SILVER SPRING, Md., June 18, 2020 /PRNewswire/

Additional Resources:

https://www.prnewswire.com/news-releases/fda-approves-first-therapy-for-rare-disease-that-causes-low-phosphate-blood-levels-bone-softening-301079748.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633085/

https://www.frontiersin.org/articles/10.3389/fendo.2018.00267/full

https://seekingalpha.com/symbol/RARE

https://www.ultragenyx.com/

https://www.crysvita.com/

https://www.ultragenyx.com/medicines/crysvita/

What is CRYSVITA? CRYSVITA is a prescription medicine used to treat adults and children 6 months of age and older with X-linked hypophosphatemia (XLH).

biotecMAX™ May/June 2020 Insight

TAZVERIK™ (tazemetostat)

PTX-35 is a novel,first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3)

Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma

Thu June 18, 2020 1:31 PM|Business Wire|About: EPZM

TAZVERIK Now Approved for Second Indication

Commercial Organization Fully Prepared to Support Successful Launch in Follicular Lymphoma

Company to Host Conference Call Today at 2:30 p.m. ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Epizyme, Inc (EPZM). (Nasdaq:EPZM)

https://www.businesswire.com/news/home/20200618005820/en/

Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Adv. Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With DLBCL

https://clinicaltrials.gov/ct2/show/NCT01897571

http://www.epizyme.com/uspi/TAZVERIK.pdf

https://seekingalpha.com/news/3584282-fda-oks-epizymes-tazemetostat-for-treatment-resistant-follicular-lymphoma

https://seekingalpha.com/symbol/EPZM

https://www.tazverik.com/

Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma

Jun 18, 2020

https://epizyme.gcs-web.com/news-releases/news-release-details/epizyme-announces-us-fda-accelerated-approval-tazveriktm-0

TAZVERIK™ (tazemetostat) is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

PTX-35 is a novel,first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3)

Heat Biologics Announces Initiation of the Lead Clinical Trial Site for PTX-35

Thu June 18, 2020 7:30 AM|Accesswire|About: HTBX

Anthony Tolcher, M.D., FRCPC appointed as the lead investigator

DURHAM, NC / ACCESSWIRE / June 18, 2020 / Heat Biologics, Inc. (HTBX) ("Heat") (NASDAQ:HTBX)

https://www.heatbio.com/

PTX-35: A potential first-in-class T cell co-stimulator targeting TNFRSF25 (Death Receptor 3)

https://www.heatbio.com/product-pipeline/ptx-35

https://seekingalpha.com/symbol/HTBX

PTX-35 in Patients With Advanced Solid Tumors

https://clinicaltrials.gov/ct2/show/NCT04430348?term=ptx-35&draw=2&rank=1

Heat Biologics advances early-stage study of cancer candidate PTX-35

Jun. 18, 2020 8:06 AM ET|About: Heat Biologics, Inc. (HTBX)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3584094-heat-biologics-advances-early-stage-study-of-cancer-candidate-ptxminus-35

https://www.heatbio.com/

Heat Biologics Announces Initiation of the Lead Clinical Trial Site for PTX-35 Thursday, June 18, 2020 7:30 AM EDT Anthony Tolcher, M.D., FRCPC appointed as the lead investigator DURHAM, NC / ACCESSWIRE / June 18, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX)

Irinotecan (ONIVYDE®)

PTX-35 is a novel,first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3)

nedosiran, an investigational RNAi therapy

Ipsen Receives FDA Fast Track Designation for Liposomal Irinotecan (ONIVYDE®) as a First-Line Combination Treatment for Metastatic Pancreatic Cancer

Wed June 17, 2020 1:00 AM|Business Wire|About: IPSEY

– Final analysis of the Phase 1/2 clinical study to be presented as a late-breaking virtual presentation at the ESMO World Congress on Gastrointestinal Cancer (WCGI) on July 1, 2020 –

PARIS--(BUSINESS WIRE)-- Regulatory News:

Ipsen (IPSEF) (Euronext: IPN; ADR: IPSEY)

https://www.businesswire.com/news/home/20200616005954/en/

JUNE 17, 2020

Ipsen receives FDA Fast Track designation for liposomal irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer

https://www.ipsen.com/press-releases/7762/

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (NAPOLI 3)

https://clinicaltrials.gov/ct2/show/NCT04083235

https://seekingalpha.com/symbol/IPSEY

www.ipsen.com

https://www.onivyde.com/for-patients/

What Is ONIVYDE Used For? ONIVYDE is a prescription medicine used to treat pancreatic cancer which has spread to other parts of the body. ONIVYDE can be used in patients who have already received gemcitabine treatment for their pancreatic cancer. ONIVYDE is given in combination with 2 other medicines, fluorouracil (also known as 5-FU) and leucovorin (which is often abbreviated as LV), and is not given alone.

nedosiran, an investigational RNAi therapy

giroctocogene fitelparvovec (SB-525, or PF-07055480), an investigational gene therapy

nedosiran, an investigational RNAi therapy

Dicerna Receives Rare Pediatric Disease Designation From U.S. Food and Drug Administration for Nedosiran for Treatment of Primary Hyperoxaluria

Thu June 18, 2020 7:30 AM|Business Wire|About: DRNA

LEXINGTON, Mass.--(BUSINESS WIRE)-- Dicerna Pharmaceuticals, Inc. (DRNA) (Nasdaq: DRNA)

https://www.businesswire.com/news/home/20200618005175/en/

https://dicerna.com/

Pipeline

https://dicerna.com/pipeline/

https://seekingalpha.com/symbol/DRNA

Only investigational RNAi therapy in development for all three known types of PH

giroctocogene fitelparvovec (SB-525, or PF-07055480), an investigational gene therapy

Pfizer and Sangamo Announce Updated Phase 1/2 Results Showing Sustained Factor VIII Activity Levels and No Bleeding Events or Factor Usage in 3e13 vg/kg Cohort Following giroctocogene fitelparvovec (SB-525) Gene Therapy

Thu June 18, 2020 9:00 AM|Business Wire|About: PFE, SGMO

— Dosing of the first patient in the pivotal Phase 3 study anticipated in second half of 2020 —

NEW YORK & BRISBANE, Calif.--(BUSINESS WIRE)-- Pfizer Inc. (PFE) and Sangamo Therapeutics, Inc. (SGMO)

https://www.businesswire.com/news/home/20200618005091/en/

https://www.sangamo.com/

https://www.sangamo.com/pipeline

https://www.sangamo.com/clinical-trials

https://seekingalpha.com/symbol/SGMO

INVESTIGATING FUTURE THERAPIES

Tecentriq in Combination With Chemotherapy (including Abraxane)

giroctocogene fitelparvovec (SB-525, or PF-07055480), an investigational gene therapy

Genentech’s Tecentriq in Combination With Chemotherapy (including Abraxane) Meets Primary Endpoint of Improved Pathological Complete Response, Regardless of PD-L1 Status, as Initial Treatment for People With Early Triple-negative Breast Cancer

Thu June 18, 2020 1:00 AM|Business Wire|About: RHHBY

— IMpassion031 data will be discussed with health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency —

— Tecentriq is the only approved cancer immunotherapy for the treatment of metastatic triple-negative breast cancer, a very aggressive and difficult-to-treat form of breast cancer —

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

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

https://www.businesswire.com/news/home/20200617005876/en/

https://www.gene.com/

https://www.abraxane.com/

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)

https://clinicaltrials.gov/ct2/show/NCT03197935?term=IMpassion031&draw=2&rank=1

https://www.gene.com/media/press-releases/14860/2020-06-17/genentechs-tecentriq-in-combination-with

What is the most important information about TECENTRIQ? TECENTRIQ can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

BRUKINSA® (Zanubrutinib)

valoctocogene roxaparvovec, an investigational gene therapy

BeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia

Thu June 18, 2020 7:30 AM|GlobeNewswire|About: BGNE

CAMBRIDGE, Mass. and BEIJING, China, June 18, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

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

Please see full Prescribing Information including Patient Information.

https://www.brukinsa.com/

https://www.beigene.com/

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-european-medicines-agency-acceptance-its

https://rarediseases.org/rare-diseases/waldenstroms-macroglobulinemia/#:~:text=Waldenstr%C3%B6m

https://seekingalpha.com/symbol/BGNE

What is BRUKINSA? BRUKINSA is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer. It is not known if BRUKINSA is safe and effective in children.

valoctocogene roxaparvovec, an investigational gene therapy

BioMarin Provides Additional Data from Recent 4 Year Update of Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A in Late-Breaking Oral Presentation at World Federation of Hemophilia Virtual Summit

Wed June 17, 2020 9:20 AM|PR Newswire|About: BMRN

Greater than 90% Reduction in Bleeding Episodes, Cumulative Mean Annualized Bleeding Rates Remain Less than One (1)

Webinar with BioMarin Management and Study Investigators, Professor John Pasi and Dr. Steve Pipe Today at 5:00 PM ET

PR Newswire

SAN RAFAEL, Calif., June 17, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

https://www.prnewswire.com/news-releases/biomarin-provides-additional-data-from-recent-4-year-update-of-ongoing-phase-12-study-of-valoctocogene-roxaparvovec-gene-therapy-for-severe-hemophilia-a-in-late-breaking-oral-presentation-at-world-federation-of-hemophilia-virtual-301078398.html

https://www.biomarin.com/

https://investors.biomarin.com/2020-06-17-BioMarin-Provides-Additional-Data-from-Recent-4-Year-Update-of-Ongoing-Phase-1-2-Study-of-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Severe-Hemophilia-A-in-Late-Breaking-Oral-Presentation-at-World-Federation-of-Hemophilia-Virtual-Summit

https://www.biomarin.com/products/pipeline/bmn-270/

https://seekingalpha.com/symbol/BMRN

Valoctocogene Roxaparvovec (BMN 270) for Hemophilia A Valoctocogene roxaparvovec is gene therapy designed for the treatment of Hemophilia A.

Zepzelca™ (lurbinectedin)

valoctocogene roxaparvovec, an investigational gene therapy

Zepzelca™ (lurbinectedin)

Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer

Mon June 15, 2020 3:35 PM|PR Newswire|About: JAZZ

Zepzelca is approved under accelerated approval based on overall response rate and duration of response demonstrated in an open-label, monotherapy clinical trial

Zepzelca is expected to be commercially available in the U.S. in early July

Investor webcast on Wednesday, June 17 at 6:15 p.m. EDT

PR Newswire

DUBLIN, June 15, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (JAZZ)

https://www.jazzpharma.com/

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here. < http://pp.jazzpharma.com/pi/zepzelca.en.USPI.pdf >

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-accelerated-approval-of-zepzelca-lurbinectedin-for-the-treatment-of-metastatic-small-cell-lung-cancer-301077082.html

https://seekingalpha.com/symbol/JAZZ

Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer June 15, 2020 Download PDF Approval represents an important advance for adult patients whose metastatic SCLC has progressed on or after platinum-based chemotherapy Zepzelca is approved under accelerated approval based on overall response rate and duration of response demonstrated in an open-label, monotherapy clinical trial Zepzelca is expected to be commercially available in the U.S. in early July Investor webcast on Wednesday, June 17 at 6:15 p.m. EDT DUBLIN, June 15, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)

XTANDI® (enzalutamide)

Mylotarg (gemtuzumab ozogamicin)

Zepzelca™ (lurbinectedin)

Health Canada Approves XTANDI® (enzalutamide), for the treatment of metastatic castration-sensitive prostate cancer (mCSPC)¹

Tue June 16, 2020 7:00 AM|Canada Newswire

XTANDI® is the first and only androgen receptor-axis-targeted therapy (ARAT) approved by Health Canada in three clinical disease states of prostate cancer across four indications2

MARKHAM, ON, June 16, 2020 /CNW/ - Astellas Pharma Canada, Inc., announced that Health Canada

https://www.astellas.com/us/

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

https://www.astellas.com/ca/en/news/1231

https://seekingalpha.com/symbol/ALPMF

What is XTANDI? XTANDI is a prescription medicine used to treat men with prostate cancer that: no longer responds to a hormone therapy or surgical treatment to lower testosterone OR has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone

Mylotarg (gemtuzumab ozogamicin)

FDA OKs expanded label for Pfizer's antibody-drug conjugate Mylotarg

Jun. 16, 2020 11:51 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

https://www.mylotarg.com/

INDICATIONS

MYLOTARG (gemtuzumab ozogamicin) is a prescription medicine used to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) or patients over the age of 2 with CD33-positive AML whose disease returned or did not respond to previous treatment.

Please see full Prescribing Information, including BOXED WARNING