Mon April 6, 2020 8:31 AM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., April 6, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

 https://www.biomarin.com/ 

 https://www.prnewswire.com/news-releases/biomarin-plans-regulatory-submissions-for-marketing-authorization-of-vosoritide-to-treat-children-with-achondroplasia-in-3q-2020-in-both-us-and-europe-301035652.html 

 https://seekingalpha.com/symbol/BMRN 

 https://www.biomarin.com/products/pipeline/bmn-111/ 

 https://investors.biomarin.com/2020-04-06-BioMarin-Plans-Regulatory-Submissions-for-Marketing-Authorization-of-Vosoritide-to-Treat-Children-with-Achondroplasia-in-3Q-2020-in-both-US-and-Europe 

 Achondroplasia 

 https://ghr.nlm.nih.gov/condition/achondroplasia 

Mon April 6, 2020 7:05 AM|GlobeNewswire|About: ESPR

– First Non-Statin, LDL-C Lowering Combination Medicine Ever Approved in Europe –

– NUSTENDI Is Approved for Patients Who Require Additional LDL-Cholesterol Lowering on a Background Statin, Other Lipid-Lowering Therapies, or Considered Statin Intolerant –

– Daiichi Sankyo Europe to Lead EU Commercialization, Cardiovascular Sales Organization Exceeds 1,000 Professionals –

– Esperion to Receive $150 Million Milestone Payment Upon First Commercial Sale –

ANN ARBOR, Mich., April 06, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.

The European Commission approved NUSTENDI for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe,
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, or
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

 https://www.esperion.com/ 

 https://www.esperion.com/science/bempedoic-acid-ezetimibe-combo-tablet/ 

 https://seekingalpha.com/symbol/ESPR 

Mon April 6, 2020 8:00 AM|GlobeNewswire|About: IMMU

Decision based on recommendation from DSMC following study data review

Sacituzumab govitecan has the potential to be the first FDA-approved antibody-drug conjugate for the treatment of metastatic triple-negative breast cancer

Conference call and webcast today at 8:00 a.m. Eastern Time

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

 https://www.immunomedics.com/ 

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

 https://clinicaltrials.gov/ct2/show/NCT02574455?term=NCT02574455&rank=1 

 https://www.immunomedics.com/our-science/clinical-trials/ 

 https://seekingalpha.com/symbol/IMMU 

Mon April 6, 2020 8:00 AM|Business Wire|About: TAK

– Approval Based on Positive Results from the Phase 3 ALTA-1L Trial Showing ALUNBRIG Demonstrated Superior Overall and Intracranial Effectiveness over Crizotinib in the First-line Setting –

– Expanded Indication Provides Additional First-Line Treatment Option for the Approximately 10,000 People with ALK+ NSCLC in Europe –

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

 https://www.businesswire.com/news/home/20200406005146/en/ 

 https://www.takeda.com/ 

 https://www.takedaoncology.com/ 

brigatinib

 https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig 

 https://www.takeda.com/newsroom/newsreleases/2020/european-commission-approves-takedas-alunbrig-brigatinib-as-a-first-line-treatment-for-alk-nsclc/ 

 https://seekingalpha.com/symbol/TAK 

Mon April 6, 2020 7:30 AM|PR Newswire|About: LMNXPR Newswire

AUSTIN, Texas, April 6, 2020 /PRNewswire/ -- Luminex Corporation (LMNX)

 https://www.prnewswire.com/news-releases/luminex-receives-fda-emergency-use-authorization-for-aries-sars-cov-2-assay-to-detect-virus-responsible-for-covid-19-disease-301035578.html 

 https://www.luminexcorp.com/ 

 https://seekingalpha.com/symbol/LMNX 

Tue April 7, 2020 6:45 AM|Business Wire|About: MRK

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

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

 https://clinicaltrials.gov/ct2/show/NCT02628067 

 https://www.merck.com/index.html 

First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer

Merck to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress

Thursday, April 2, 2020 6:45 am EDT 

 https://www.mrknewsroom.com/news-release/oncology/merck-announces-keytruda-pembrolizumab-significantly-improved-progression-free 

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Tuesday, April 7, 2020 6:45 am EDT 

 https://www.mrknewsroom.com/news-release/oncology-newsroom/merck-receives-priority-review-fda-second-application-keytruda-pembro 

 https://www.businesswire.com/news/home/20200407005141/en/ 

 https://seekingalpha.com/symbol/MRK 

 https://www.keytruda.com/ 

Thu April 2, 2020 2:04 PM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the European Commission (EC) has approved RUXIENCE™ (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera® (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3

 https://www.pfizer.com/ 

 https://www.businesswire.com/news/home/20200402005733/en/ 

 https://seekingalpha.com/symbol/PFE 

Thursday, April 2, 2020 - 2:04pmEDT 

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

Fri April 3, 2020 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, April 3, 2020 /PRNewswire/ 

 https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf 

 https://www.regeneron.com/ 

 https://www.prnewswire.com/news-releases/dupixent-dupilumab-phase-3-data-at-revolutionizing-atopic-dermatitis-conference-show-significant-improvement-in-severe-atopic-dermatitis-for-children-aged-6-to-11-years-301034556.html 

 https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-phase-3-data-revolutionizing-atopic 

 https://seekingalpha.com/symbol/REGN 

 https://seekingalpha.com/symbol/SNY 

Fri April 3, 2020 9:00 AM|PR Newswire|About: JNJPR Newswire

SOUTH SAN FRANCISCO, Calif., April 3, 2020 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson (JNJ)

 https://journal.chestnet.org/article/S0012-3692(19)34214-X/fulltext 

 https://seekingalpha.com/symbol/ALIOF 

 https://www.janssen.com/ 

 https://www.jnj.com/ 

 https://www.prnewswire.com/news-releases/results-from-expert-delphi-consensus-survey-on-treatment-of-pulmonary-arterial-hypertension-pah-with-oral-prostacyclin-pathway-agents-ppas-published-in-chest-journal-301034862.html 

 https://seekingalpha.com/symbol/JNJ 

 https://uptravi.com/ 

 https://www.actelion.us/products/index 

Apr. 3, 2020 9:24 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor  
03 April 2020

https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-is-the-first-anti-il5-biologic-to-report-positive-phase-3-results-in-patients-with-nasal-polyps/
https://www.nucala.com/
 

https://clinicaltrials.gov/ct2/show/NCT03085797?titles=synapse&lead=glaxosmithkline&phase=2&draw=2&rank=1
https://seekingalpha.com/symbol/GSK
https://seekingalpha.com/symbol/BMY  

Fri April 3, 2020 5:08 PM|Business Wire|About: BMY, XLRN

The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent

Reblozyl regulates late-stage RBC maturation to relieve patients from the burden of regular RBC transfusions

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/ 

 https://media2.celgene.com/content/uploads/reblozyl-pi.pdf 

 https://www.businesswire.com/news/home/20200403005530/en/ 

 https://seekingalpha.com/symbol/XLRN 

 https://seekingalpha.com/symbol/BMY 

Sun April 5, 2020 8:00 AM|Business Wire|About: INCY

- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or 1 (almost clear), and EASI75 (key secondary endpoint), defined as the proportion of patients who achieved a ≥ 75% improvement in the Eczema Area and Severity Index Score
- Treatment with ruxolitinib cream also resulted in a rapid, substantial and sustained reduction in itch, a key quality of life measure for patients with atopic dermatitis
- Data support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration before the end of 2020

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

 https://virtual.revolutionizingad.com/events/6 

 https://clinicaltrials.gov/ct2/show/NCT03745638 

 https://clinicaltrials.gov/ct2/show/NCT03745651 

 https://www.businesswire.com/news/home/20200405005012/en/ 

 https://seekingalpha.com/symbol/INCY 

Wed April 1, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, April 01, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

 https://www.cytodyn.com/ 

 https://www.cytodyn.com/pipeline 

 https://www.cytodyn.com/newsroom/press-releases/detail/404/cytodyn-files-a-clinical-trial-protocol-with-the-fda-to 

 https://seekingalpha.com/symbol/CYDY 

Thu April 2, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

 https://seekingalpha.com/pr/17826137-treatment-cytodyns-leronlimab-indicates-significant-trend-toward-immunological-restoration-in 

Wed April 1, 2020 1:12 PM|PR NewswirePR Newswire

SILVER SPRING, Md., April 1, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies)

 https://www.cdc.gov/ncbddd/hemophilia/data.html 

 https://www.prnewswire.com/news-releases/fda-approves-additional-treatment-for-adults-and-adolescents-with-hemophilia-a-or-b-and-inhibitors-301033506.html 

Apr. 1, 2020 1:51 PM ET|About: uniQure N.V. (QURE)|By: Douglas W. House, SA News Editor  

 https://seekingalpha.com/news/3557408-fda-oks-new-hemophilia-treatment 

 https://www.groupe-lfb.com/en/ 

Thu April 2, 2020 6:45 AM|Business Wire|About: MRK

First Positive Head-to-Head Phase 3 Trial Comparing a Single-Agent Cancer Medicine to Standard of Care Chemotherapy as First-line Treatment for MSI-H or dMMR Colorectal Cancer

Merck (MRK) to Share Data from KEYNOTE-177 with Global Regulatory Authorities and at an Upcoming Medical Congress

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

 https://clinicaltrials.gov/ct2/show/NCT02563002 

 https://www.merck.com/index.html 

 https://www.mrknewsroom.com/news-release/oncology/merck-announces-keytruda-pembrolizumab-significantly-improved-progression-free 

 https://www.businesswire.com/news/home/20200402005209/en/ 

 https://seekingalpha.com/symbol/MRK 

Thu April 2, 2020 6:00 AM|PR Newswire|About: EXASPR Newswire

MADISON, Wis., April 2, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS) 

 https://www.prnewswire.com/news-releases/exact-sciences-highlights-the-opportunity-to-seek-screening-with-cologuard-through-telehealth-301033897.html 

 https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html 

 https://www.exactsciences.com/ 

 https://seekingalpha.com/symbol/EXAS 

Thu April 2, 2020 8:00 AM|Business Wire|About: SGEN

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

 https://seekingalpha.com/pr/17826303-seattle-genetics-announces-potential-accelerated-approval-pathway-in-u-s-for-padcev 

Apr. 2, 2020 8:48 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor 

 https://seekingalpha.com/news/3557770-seattle-genetics-padcev-may-nab-accelerated-review-for-first-line-urothelial-cancer  

 https://www.seattlegenetics.com/ 

 https://clinicaltrials.gov/ct2/show/NCT03288545?term=ev-103&draw=2&rank=1 

 https://seekingalpha.com/symbol/SGEN 

Thu April 2, 2020 8:30 AM|Business Wire|About: GILD

-- Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies --

SANTA MONICA, Calif. & NEWARK, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc. 

 https://www.businesswire.com/news/home/20200402005067/en/ 

 https://www.kitepharma.com/ 

 https://www.gilead.com/ 

 https://www.teneobio.com/ 

 https://www.teneobio.com/pipeline/ 

 https://seekingalpha.com/symbol/GILD 

 https://www.teneobio.com/technology/ngs-based-discovery/ 

Tue March 31, 2020 7:00 AM|GlobeNewswire|About: AMRN

DUBLIN, Ireland and BRIDGEWATER, N.J., March 31, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

 https://virtual.acc.org/on-demand/acc-videos#nav_jump 

 https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/157?q=1263-090 

 https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/367?q=1212-205 

 https://cslide-us.ctimeetingtech.com/acc2020_eposter/attendee/eposter/poster/388?q=1364-202 

 https://amarincorp.com/ 

INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS VASCEPA?

VASCEPA is a prescription medicine used:

• along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease.
• along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

 https://seekingalpha.com/symbol/AMRN 

Tue March 31, 2020 7:00 AM|PR Newswire|About: BHC

Study Arm Evaluating 40 MG BID of Rifaximin SSD IR In Combination with Standard of Care Therapy Met Primary Endpoint

LAVAL, Quebec, March 31, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC)

 https://www.bauschhealth.com/ 

 https://www.prnewswire.com/news-releases/bausch-health-announces-favorable-topline-results-from-study-evaluating-investigative-formulation-of-rifaximin-ssd-ir-to-treat-overt-hepatic-encephalopathy-301032189.html 

 https://seekingalpha.com/symbol/BHC 

 https://www.salix.com/ 

 https://www.bauschhealth.com/news-room/news-releases/news-details/202003310700pr_news_uspr_____ny65880 

Tue March 31, 2020 6:59 AM|Business Wire|About: BLUE, BMY

BLA submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient population with relapsed and refractory multiple myeloma

PRINCETON, NJ. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

 https://www.bluebirdbio.com/ 

 https://www.bms.com/ 

 https://www.businesswire.com/news/home/20200331005194/en/ 

 https://seekingalpha.com/symbol/BMY 

 https://seekingalpha.com/symbol/BLUE 

Tue March 31, 2020 8:00 AM|Business Wire|About: TAK

– Opinion Based on Phase 3 ECHELON-2 Study Which Demonstrated ADCETRIS Plus Chemotherapy Resulted in a Statistically Significant Improvement in Progression-Free Survival Compared to a Standard of Care –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--

Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

 https://www.adcetris.com/ 

 https://www.takeda.com/investors/ 

 https://www.takeda.com/ 

 https://www.takedaoncology.com/ 

 https://www.businesswire.com/news/home/20200331005020/en/ 

 https://seekingalpha.com/symbol/TAK 

Tue March 31, 2020 7:30 AM|GlobeNewswire|About: NTLA

CAMBRIDGE, Mass., March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NTLA)

 https://www.intelliatx.com/ 

 https://www.intelliatx.com/pipeline-2/ 

 https://www.intelliatx.com/publications-and-presentations-2/ 

 All News2020201920182017201620152014

• MAR 31, 2020
  FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics
  CAMBRIDGE, Mass. , March 31, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA),

 https://ir.intelliatx.com/news-releases 

 https://seekingalpha.com/symbol/NTLA 

Mar. 31, 2020 10:19 AM ET|About: Intellia Therapeutics,... (NTLA)|By: Douglas W. House, SA News Editor 

 https://seekingalpha.com/news/3556807-fda-signs-off-on-study-of-crispr-drug-for-sickle-cell-disease 

 https://seekingalpha.com/symbol/NVS 

 01-Apr-2020

• Remdesivir is an investigational agent – it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use.
• The UK is one of the countries where Gilead is running clinical trials to evaluate remdesivir for the treatment of COVID-19

London, April 1st 2020 – Gilead Sciences

Apr. 1, 2020 7:57 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor 

 https://seekingalpha.com/news/3557138-gilead-sciences-launches-two-remdesivir-studies-in-uk 

Mon March 30, 2020 11:46 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ -- 

Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; FDA regulatory submission planned for Q2 2020

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

 https://www.nejm.org/doi/full/10.1056/NEJMoa1612790 

 https://www.regeneron.com/ 

 https://www.prnewswire.com/news-releases/regeneron-announces-american-college-of-cardiology-presentation-of-positive-phase-3-evinacumab-results-in-patients-with-severe-inherited-form-of-high-cholesterol-301031790.html 

 https://seekingalpha.com/symbol/REGN 

Mon March 30, 2020 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, March 30, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)

 http://pi.lilly.com/us/taltz-uspi.pdf 

 https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-receives-us-fda-approval-treatment-1 

 https://www.psoriasis.org/content/statistics 

 https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-receives-us-fda-approval-for-the-treatment-of-pediatric-patients-with-moderate-to-severe-plaque-psoriasis-301031305.html 

Mon March 30, 2020 4:15 PM|GlobeNewswire|About: ESPR

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine in the U.S. in Nearly 20 Years for Indicated Patients Awaiting a New Option –
– Esperion Aims to Set New Industry Standard by Pricing NEXLETOL for Patient Affordability and Access –
– Company Repurposes Healthcare Provider Education and Support Material Encouraging Remote Education and Virtual Visits with our Lipid Experts During This Extraordinary Time –

ANN ARBOR, Mich., March 30, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)

 https://www.esperion.com/ 

 https://pi.esperion.com/nexletol/nexletol-pi.pdf 

 https://www.esperion.com/product/nexletol/ 

 https://www.esperion.com/investors-media/press-releases/?request=aHR0cHM6Ly9lc3Blcmlvbi5nY3Mtd2ViLmNvbS8vbmV3cy1yZWxlYXNlcy9uZXdzLXJlbGVhc2UtZGV0YWlscy9lc3Blcmlvbi1hbm5vdW5jZXMtY29tbWVyY2lhbC1hdmFpbGFiaWxpdHktbmV4bGV0b2x0bS1iZW1wZWRvaWM= 

 https://seekingalpha.com/symbol/ESPR 

Tue March 31, 2020 4:05 AM|Business Wire|About: QGEN

• First syndromic testing solution to be deployed in epidemic can differentiate novel coronavirus from 21 other serious respiratory infections
• QIAstat-Dx Respiratory SARS-CoV-2 Panel delivers results in about one hour
• Adds an important tool for clinicians as part of QIAGEN’s global mobilization to scale up testing supplies for the COVID-19 response

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

 https://www.businesswire.com/news/home/20200331005294/en/ 

 https://www.qiagen.com/us/ 

 https://seekingalpha.com/symbol/QGEN 

Tue March 31, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, March 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

 https://www.cytodyn.com/ 

 https://www.cytodyn.com/pipeline 

 https://seekingalpha.com/symbol/CYDY 

Tue March 31, 2020 7:00 AM|GlobeNewswire|About: GWPHGlobeNewswire

CARLSBAD, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)

 https://www.gwpharm.com/ 

 https://www.epidiolex.com/ 

 https://seekingalpha.com/symbol/GWPH 

 https://www.greenwichbiosciences.com/ 

 https://ghr.nlm.nih.gov/condition/tuberous-sclerosis-complex 

Mon March 30, 2020 9:16 AM|Business Wire|About: AZN

BRILINTA monotherapy reduced bleeding complications with no increased risk of ischemic events in patients with diabetes undergoing percutaneous coronary intervention

Consistent results were also observed in patients undergoing complex percutaneous coronary intervention

WILMINGTON, Del.--(BUSINESS WIRE)

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

 https://www.astrazeneca-us.com/ 

 https://www.businesswire.com/news/home/20200330005412/en/ 

 Brilinta reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial 

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/brilinta-reduced-bleeding-vs-dual-therapy-in-high-risk-coronary-patients-in-sub-analyses-from-phase-iv-twilight-trial.html 

 https://seekingalpha.com/symbol/AZN 

PUBLISHED30 March 2020

AstraZeneca’s Imfinzi (durvalumab

 https://www.astrazeneca.com/ 

 https://seekingalpha.com/symbol/AZN 

 https://www.astrazeneca.com/our-therapy-areas/oncology.html 

Mon March 30, 2020 10:00 AM|GlobeNewswire|About: MDT

First Study in the U.S. and Japan to Report Results on One-Month DAPT Duration in High Bleeding Risk Patients with Current-Generation DES

DUBLIN, March 30, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT)

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

 http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-onyx-one-clear-study-one-month-dual-antiplatelet 

 https://seekingalpha.com/symbol/MDT 

Mon March 30, 2020 8:00 AM|GlobeNewswire|About: OVID

Soticlestat continues to appear to be safe and well-tolerated; the majority of the 11 patients showed a reduction in seizures

All patients that have completed the Phase 2 ARCADE study to date have opted to enroll in the ENDYMION open-label extension study

NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (OVID)

 https://seekingalpha.com/symbol/TKPHF 

 https://ovidrx.com/ 

 https://seekingalpha.com/symbol/OVID 

 https://clinicaltrials.gov/ct2/show/NCT03694275?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=2 

 https://clinicaltrials.gov/ct2/show/NCT03635073?cond=CDKL5+Deficiency+Disorder&phase=1&draw=2&rank=1 

Mon March 30, 2020 8:00 AM|Business Wire|About: A

Purpose-built and validated for clinical laboratories

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) (NYSE: A) today introduced the Agilent K6460S Clinical Edition TQ LC/MS system, designed to improve in vitro diagnostic workflows in clinical labs.

 https://www.agilent.com/cs/library/brochures/brochure-clinical-diagnostics-k6460s-lcms-5994-1680en-agilent.pdf 

 https://www.agilent.com/ 

 https://www.businesswire.com/news/home/20200330005195/en/ 

 https://seekingalpha.com/symbol/A 

Mon March 30, 2020 11:45 AM|GlobeNewswire|About: AMRN

• Serum EPA Levels Showed Approximately 400% Increase Following Administration of VASCEPA 
• High EPA Levels Associated with Substantial Reductions in Multiple Cardiovascular Endpoints Including Heart Failure and Total Mortality

Amarin to Webcast Discussion of Presented Data March 30, 5:30 - 6:30 p.m., Eastern Time

DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

 https://amarincorp.com/ 

 https://virtual.acc.org/

 https://www.vascepa.com/assets/pdf/Vascepa_PI.pdf 

 https://seekingalpha.com/symbol/AMRN 

Sat March 28, 2020 9:53 AM|Business Wire|About: AZN

New data showed consistent effect of FARXIGA in patients with heart failure with reduced ejection fraction, regardless of background therapy

WILMINGTON, Del.-

 https://www.astrazeneca-us.com/ 

 https://www.businesswire.com/news/home/20200328005007/en/ 

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

 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/farxiga-granted-fda-priority-review-for-patients-with-heart-failure-with-reduced-ejection-fraction-01062020.html 

 https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaa183/5813081 

 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/farxiga-approved-in-the-US-to-reduce-the-risk-of-hospitalization-for-heart-failure-in-patients-with-type-2-diabetes-10212019.html 

 https://seekingalpha.com/symbol/AZN 

 https://www.farxiga-hcp.com/ 

Sun March 29, 2020 9:00 AM|GlobeNewswire|About: MDT

ACC.20/WCC: Low Rates of Paravalvular Leak and High Survival Observed in Late-breaking Clinical Trial of Low-Risk Bicuspid Aortic Stenosis Patients

DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT)

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

 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2999052/ 

 http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-evolut-tavr-system-demonstrates-excellent-outcomes 

 https://seekingalpha.com/symbol/MDT 

Sun March 29, 2020 11:45 AM|GlobeNewswire|About: MDT

ACC.20/WCC: Study Finds Significant Blood Pressure Reductions Achieved with RDN in Absence of Anti-Hypertensive Medication 

Medtronic Receives FDA “Breakthrough Device Designation” for Symplicity Spyral™ Renal Denervation System

DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (MDT) (NYSE:MDT)

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

 http://newsroom.medtronic.com/news-releases/news-release-details/landmark-spyral-htn-med-pivotal-trial-shows-superiority-renal 

 https://clinicaltrials.gov/ct2/show/study/NCT02064764?term=Symplicity+AF&rank=1#contacts 

 https://seekingalpha.com/symbol/MDT 

Mon March 30, 2020 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, March 30, 2020 /PRNewswire/ -- 

Phase 2/3 trial initiated in Italy, Spain, Germany, France, Japan, Canada and Russia and is enrolling patients immediately

Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection

Regeneron is leading U.S. trials, Sanofi is leading ex-U.S. trials

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

 https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-begin-global-kevzarar-sarilumab-clinical 

 https://www.regeneron.com/ 

 https://www.prnewswire.com/news-releases/first-patient-outside-us-treated-in-global-kevzara-sarilumab-clinical-trial-program-for-patients-with-severe-covid-19-301031444.html 

 https://seekingalpha.com/symbol/REGN 

 https://seekingalpha.com/symbol/SNY 

Mon March 30, 2020 6:00 AM|GlobeNewswire|About: AXSM 

 https://axsome.com/ 

 https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-topline-results-stride-1-phase-3?field_nir_news_date_value[min]= 

 https://seekingalpha.com/symbol/AXSM 

Mon March 30, 2020 7:05 AM|Business Wire|About: AZN

FARXIGA is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics

WILMINGTON, Del.--(BUSINESS WIRE)

 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/farxiga-met-primary-endpoint-in-landmark-phase-iii-dapa-hf-trial-for-the-treatment-of-patients-with-heart-failure-08202019.html 

 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/farxiga-approved-in-the-US-to-reduce-the-risk-of-hospitalization-for-heart-failure-in-patients-with-type-2-diabetes-10212019.html 

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

 https://www.astrazeneca-us.com/ 

 https://www.businesswire.com/news/home/20200330005322/en/ 

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-phase-iii-dapa-ckd-trial-will-be-stopped-early-after-overwhelming-efficacy-in-patients-with-chronic-kidney-disease.html 

 https://seekingalpha.com/symbol/AZN 

Fri March 27, 2020 11:05 AM|Business Wire|About: BMY

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

 https://www.businesswire.com/news/home/20200327005326/en/ 

 https://seekingalpha.com/symbol/BMY 

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

 On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zolgensma1, intended for the treatment of babies and young children who have a rare, serious inherited condition called spinal muscular atrophy (SMA). 

Mar. 27, 2020 9:49 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor  

 https://seekingalpha.com/news/3555880-european-advisory-group-backs-novartis-gene-therapy-for-sma 

 https://seekingalpha.com/symbol/NVS 

Mar 27, 2020
 

• EMA CHMP positive opinion in non-radiographic axial spondyloarthritis (nr-axSpA) paves way for fourth indication in Europe, and is based on Phase III PREVENT data1
   
• If approved, Cosentyx would become the first fully-human IL-17A inhibitor indicated for patients in Europe with nr-axSpA
   
• There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US, which forms part of the axial spondyloarthritis (axSpA) disease spectrum2
   
• Cosentyx is backed by five years of clinical data supporting long-term safety and efficacy across ankylosing spondylitis (AS), psoriatic arthritis (PsA) and moderate-to-severe plaque psoriasis (PsO)3-6

Basel, March 27, 2020 

 https://seekingalpha.com/symbol/NVS 

Fri March 27, 2020 7:20 PM|PR Newswire|About: ABT

PR Newswire

ABBOTT PARK, Ill., March 27, 2020 /PRNewswire/ -- Abbott (ABT)

 https://www.abbott.com/ 

 https://www.prnewswire.com/news-releases/abbott-launches-molecular-point-of-care-test-to-detect-novel-coronavirus-in-as-little-as-five-minutes-301031213.html 

 https://seekingalpha.com/symbol/ABT 

 The test will run on the company's ID NOW™ platform 

By Michelle Fay CortezMarch 27, 2020, 7:21 PM EDT Updated on March 28, 2020, 8:28 AM EDT 

 https://www.bloomberg.com/news/articles/2020-03-27/abbott-launches-5-minute-covid-19-test-for-use-almost-anywhere 

Sat March 28, 2020 10:00 AM|Business Wire|About: MRK

Phase 3 VICTORIA Trial is the First Contemporary Outcomes Study Focused Exclusively on a Chronic Heart Failure Patient Population Following a Worsening Event

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

 https://seekingalpha.com/pr/17821566-investigational-drug-vericiguat-significantly-reduced-risk-of-composite-endpoint-of-heart 

Mar. 28, 2020 11:21 AM ET|About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor 

Merck (NYSE:MRK) 

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

 https://www.businesswire.com/news/home/20200328005001/en/ 

 https://seekingalpha.com/symbol/MRK 

. 

Sat March 28, 2020 10:00 AM|PR Newswire|About: AMGN

PR Newswire

THOUSAND OAKS, Calif., March 28, 2020 /PRNewswire/ -- Amgen (AMGN)

 https://www.prnewswire.com/news-releases/amgen-announces-positive-results-at-acc20wcc-from-phase-3b-study-of-repatha-evolocumab-in-people-living-with-hiv-who-have-high-ldl-cholesterol-301031307.html 

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

 https://www.amgen.com/ 

 https://www.amgen.com/media/news-releases/2020/03/amgen-announces-positive-results-at-acc20wcc-from-phase-3b-study-of-repatha-evolocumab-in-people-living-with-hiv-who-have-high-ldlcholesterol/ 

Thu March 26, 2020 6:30 AM|Business Wire|About: BMY

In clinical trials, ZEPOSIA demonstrated efficacy on a key clinical marker of disease activity – annualized relapse rate (ARR) – as compared to AVONEX® (interferon beta-1a)1,2,3

ZEPOSIA is a sphingosine-1-phosphate (S1P) receptor modulator that requires no label-based first dose observation1

ZEPOSIA adds to Bristol Myers Squibb’s legacy immunology franchise and marks the first FDA-approved New Drug Application since the Celgene acquisition

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

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

 https://www.clinicaltrials.gov/ct2/show/NCT03915769 

 https://www.businesswire.com/news/home/20200326005222/en/ 

 https://seekingalpha.com/symbol/BMY 

Thu March 26, 2020 6:59 AM|Business Wire|About: BMY, XLRN

Results demonstrate that treatment with Reblozyl provides significant reduction in transfusion burden for patients with beta thalassemia-associated anemia compared to placebo

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 

 http://acceleronpharma.com/ 

 https://www.clinicaltrials.gov/ct2/show/NCT03342404?term=BEYOND&cond=Beta-Thalassemia 

 https://clinicaltrials.gov/ct2/show/NCT04143724?term=luspatercept%2C+beta+thalassemia%2C+pediatric&draw=2&rank=1 

 https://www.clinicaltrials.gov/ct2/show/NCT03682536?term=COMMANDS+luspatercept&rank=1 

 https://www.businesswire.com/news/home/20200326005054/en/ 

 https://seekingalpha.com/symbol/BMY 

 https://seekingalpha.com/symbol/XLRN 

Thu March 26, 2020 12:49 PM|PR NewswirePR Newswire

ATHLONE, Ireland, March 26, 2020 /PRNewswire/ -- Innocoll Holdings Limited,

 https://www.prnewswire.com/news-releases/innocoll-holdings-limited-announces-fda-acceptance-of-new-drug-application-for-xaracoll-for-the-management-of-postsurgical-pain-after-open-inguinal-hernia-surgery-301030493.html 

 https://www.gurnetpointcapital.com/ 

 https://www.innocoll.com/xaracoll/ 

 https://seekingalpha.com/symbol/DRRX 

Fri March 27, 2020 2:00 AM|Business Wire|About: RHHBY

– The application seeks approval of a new, additional formulation of Xofluza as granules for oral suspension for people one year of age and older with influenza –

– The FDA also accepts a supplemental New Drug Application for the use of Xofluza for post-exposure prophylaxis, potentially offering Xofluza as a preventive treatment for influenza after exposure to an infected individual –

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

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

 https://www.businesswire.com/news/home/20200326005826/en/ 

 https://www.gene.com/ 

 https://www.gene.com/media/press-releases/14844/2020-03-26/fda-accepts-genentechs-new-drug-applicat 

 https://seekingalpha.com/symbol/RHHBY 

Fri March 27, 2020 6:15 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

Fri March 27, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

 https://seekingalpha.com/pr/17820718-leronlimab-used-in-seven-patients-severe-covidminus-19-demonstrated-promise-two-intubated 

 https://www.cytodyn.com/pipeline 

 https://seekingalpha.com/symbol/CYDY 

Fri March 27, 2020 2:05 AM|GlobeNewswire|About: SNY

Sanofi (SNY) receives positive CHMP opinion for Sarclisa® (isatuximab) for the treatment of relapsed and refractory multiple myeloma

• Positive CHMP opinion based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 in combination with pom-dex
• Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death in adults by 40% compared to pom-dex alone in the trial
• Sarclisa was approved by the FDA on March 2 in combination with pom-dex for the treatment of certain adults with RRMM
• Multiple myeloma remains an incurable cancer associated with significant patient burden and need for additional treatments

Paris – March 27, 2020 

 https://ml-eu.globenewswire.com/Resource/Download/5591b2f4-4f84-4273-a5ce-1a431e738537 

 https://seekingalpha.com/symbol/SNY 

 https://www.sanofigenzyme.com/en/ 

Wed March 25, 2020 3:01 AM|Business Wire|About: EXEL

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda (TKPHF)), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan,

 https://www.businesswire.com/news/home/20200325005214/en/ 

 https://www.exelixis.com/ 

 https://www.exelixis.com/our-medicines/ 

 https://seekingalpha.com/symbol/EXEL 

Wed March 25, 2020 7:35 AM|Business Wire|About: INFI

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Infinity Pharmaceuticals, Inc (INFI).

 http://www.infi.com/ 

March 25, 2020 at 7:35 AM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 25, 2020-- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) 

 http://investors.infi.com/news-releases/news-release-details/infinity-receives-fast-track-designation-ipi-549-combination 

 https://www.businesswire.com/news/home/20200325005100/en/ 

 http://www.infi.com/home/our-development-program/ipi-549/ 

 https://seekingalpha.com/symbol/INFI 

 https://clinicaltrials.gov/ct2/show/NCT03980041?term=mario-275&draw=2&rank=1 

 https://seekingalpha.com/symbol/BMY 

 https://www.opdivo.com/ 

Wed March 25, 2020 9:00 AM|GlobeNewswire|About: BGNE

- NMPA has suspended the importation, sales and use of ABRAXANE in China supplied by Celgene Corporation, a Bristol Myers Squibb (BMS) company

- As the marketing agent for ABRAXANE in China, BeiGene (BGNE) is working with BMS to restore supply in China

BEIJING, China, and CAMBRIDGE, Mass., March 25, 2020 (GLOBE NEWSWIRE)

 https://www.beigene.com/ 

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

 https://seekingalpha.com/symbol/BGNE 

 https://www.abraxane.com/ 

Mar. 25, 2020 9:29 AM ET|About: BeiGene, Ltd. (BGNE)|By: Douglas W. House, SA News Editor 

 https://seekingalpha.com/news/3555050-beigene-reports-abraxane-shortage-in-china 

Wed March 25, 2020 8:00 AM|GlobeNewswire|About: VIR

- Multiple antibodies identified that neutralize SARS-CoV-2
- Phase 1/2 clinical testing planned for this summer

SAN FRANCISCO, March 25, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR) 

 https://www.vir.bio/ 

 https://seekingalpha.com/symbol/VIR 

Wed March 25, 2020 4:01 PM|Business Wire|About: XNCR

MONROVIA, Calif.--(BUSINESS WIRE)-- Xencor, Inc. (XNCR)

 https://www.xencor.com/ 

 https://www.businesswire.com/news/home/20200325005490/en/ 

 https://www.xencor.com/pipeline/ 

 https://seekingalpha.com/symbol/XNCR 

 https://seekingalpha.com/symbol/VIR 

Thu March 26, 2020 2:00 AM|PR Newswire|About: TMO

PR Newswire

WALTHAM, Mass., March 26, 2020 /PRNewswire/ -- Thermo Fisher Scientific Inc. (TMO)

 https://corporate.thermofisher.com/en/COVID-19.html 

 https://www.thermofisher.com/us/en/home.html 

 https://www.prnewswire.com/news-releases/thermo-fisher-scientific-receives-ce-mark-for-its-diagnostic-test-to-detect-covid-19-301030101.html 

 https://seekingalpha.com/symbol/TMO 

Mon March 23, 2020 9:00 AM|Business Wire|About: CHGCY, RHHBY

Genentech will also provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile

Current U.S. supply of Actemra for approved indications is not expected to be impacted

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

 https://www.gene.com/covid19 

 https://seekingalpha.com/symbol/CHGCF 

 https://www.gene.com/ 

 https://www.businesswire.com/news/home/20200323005166/en/ 

 https://seekingalpha.com/symbol/RHHBY 

 https://www.gene.com/media/press-releases/14843/2020-03-23/genentech-announces-fda-approval-of-clin 

Mar. 23, 2020 4:34 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Stephen Alpher, SA News Editor 

 https://seekingalpha.com/news/3554448-gileads-remdesivir-wins-orphan-drug-status-for-coronavirus  

By MATTHEW HERPER @matthewherper

MARCH 22, 2020

 https://www.statnews.com/2020/03/22/gilead-suspends-access-to-experimental-covid-19-drug-remdesivir/ 

 https://www.statnews.com/2020/03/16/remdesivir-surges-ahead-against-coronavirus/ 

 https://seekingalpha.com/news/3554110-gilead-suspends-access-to-remdesivir-amid-flood-of-requests 

 https://seekingalpha.com/symbol/GILD 

Mon March 23, 2020 4:01 PM|PR Newswire

PR Newswire

PRINCETON, N.J., March 23, 2020 /PRNewswire/ -- Sandoz 

 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=21b08b87-70e3-4233-9531-dd6d84eab5d0&type=display 

 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4cdf4099-db58-43b8-9fbc-afd997ccfa4b&type=display 

 https://www.prnewswire.com/news-releases/sandoz-acquires-us-distribution-rights-to-two-key-hospital-injectable-medicines-reinforcing-strategic-focus-on-key-growth-segment-301028154.html 

 https://seekingalpha.com/symbol/NVS 

 https://www.novartis.com/ 

 https://www.sandoz.com/ 

Tue March 24, 2020 6:45 AM|Business Wire|About: PFE

EUCRISA is the first and only 100% steroid-free, topical prescription medication approved for patients as young as 3 months of age in the United States

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

 https://www.pfizer.com/ 

 https://www.businesswire.com/news/home/20200324005177/en/ 

 https://seekingalpha.com/symbol/PFE 

 https://www.eucrisa.com/ 

Tuesday, March 24, 2020 - 6:45amEDT

Pfizer Inc. (NYSE: PFE) 

 https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_supplemental_new_drug_application_snda_for_expanded_indication_of_eucrisa_crisaborole_ointment_2_in_children_as_young_as_3_months_of_age_with_mild_to_moderate_atopic_dermatitis 

Tue March 24, 2020 7:30 AM|Business Wire|About: INCY

Investor conference call and webcast scheduled for Monday, April 6, 2020 at 8:00 a.m. EDT

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

 https://investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-phase-3-true-ad 

 https://www.incyte.com/ 

 https://www.businesswire.com/news/home/20200324005045/en/ 

 https://seekingalpha.com/symbol/INCY 

Tue March 24, 2020 5:30 AM|Business Wire|About: QGEN

• QIAstat-Dx syndromic testing system can differentiate novel coronavirus from 20 other respiratory targets
• Requires less than one minute for sample preparation and delivers results in about one hour
• Adds an important tool for clinicians as part of QIAGEN’s global mobilization to dramatically scale up production of testing supplies for global response to COVID-19 pandemic

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

 https://www.businesswire.com/news/home/20200324005285/en/ 

 https://seekingalpha.com/symbol/QGEN 

Fri March 20, 2020 7:00 AM|GlobeNewswire|About: AXSM

Randomizations concluded and trial participation in process of concluding to ensure patient safety during COVID-19 pandemic

AXS-05 and placebo arms fully enrolled with estimated completion rate of more than 90%

Topline results now expected early 2Q 2020

NEW YORK, March 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM)

 https://axsome.com/ 

 https://seekingalpha.com/symbol/AXSM 

Fri March 20, 2020 7:00 AM|GlobeNewswire|About: SRNE

• COVIDTRAPTM is a proprietary ACE2-Fc protein that binds to the S1 domain of the spike protein of the SARS-CoV-2 virus;
• COVIDTRAP is designed to block the SARS-CoV-2 virus from binding and infecting respiratory epithelial cells, which is expected to effectively interrupt the viral life cycle;
• COVIDTRAP is engineered with a long half-life to provide prophylactic measures for at-risk populations (healthcare workers) with frequent exposure to the SARS-CoV-2 virus;
• COVIDTRAP preserves the ACE2 enzymatic activity, which is important in maintaining normal blood pressure and healthy blood flow into the infected lung tissues when used in advanced COVID-19 patients; and
• STI-4398 is in the cGMP cell line development stage and could be ready for large-scale production in Sorrento’s cGMP facilities in San Diego for human clinical trials and commercialization upon receipt of requisite regulatory approvals.   

SAN DIEGO, March 20, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE)

 https://sorrentotherapeutics.com/ 

Mar 20, 2020 at 7:00 AM EDT 

 http://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-develops-sti-4398-covidtraptm-protein-potential 

 https://seekingalpha.com/symbol/SRNE 

Fri March 20, 2020 9:00 AM|Business Wire|About: GSK, PFE

• Simultaneous approval of VOCABRIA (cabotegravir oral tablets), for short-term treatment in conjunction with CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions), also granted by Health Canada
• CABENUVA reduces treatment dosing days from 365 to 12 per year

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

 https://viivhealthcare.com/en-us/ 

 https://www.gsk.com/ 

 https://seekingalpha.com/symbol/GSK 

 https://www.businesswire.com/news/home/20200320005298/en/ 

 https://seekingalpha.com/symbol/PFE 

 https://seekingalpha.com/symbol/SGIOY 

Wed March 18, 2020 4:15 PM|Business Wire|About: PFE

JADE COMPARE trial met all co-primary endpoints

Study included dupilumab in active control arm

Safety profile for abrocitinib consistent with previous studies

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

 https://www.pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_phase_3_data_at_the_28th_congress_of_the_european_academy_of_dermatology_and_venereology_for_abrocitinib_in_moderate_to_severe_atopic_dermatitis 

 https://investors.pfizer.com/investor-news/press-release-details/2019/Pfizer-Announces-Positive-Top-Line-Results-from-Second-Pivotal-Phase-3-Study-of-Investigational-Oral-JAK1-Candidate-Abrocitinib-in-Patients-Aged-12-and-Older-with-Moderate-to-Severe-Atopic-Dermatitis/default.aspx 

 https://clinicaltrials.gov/ct2/show/NCT03720470 

 https://www.pfizer.com/ 

 https://www.businesswire.com/news/home/20200318005459/en/ 

 https://seekingalpha.com/symbol/PFE 

Sat March 21, 2020 9:00 AM|PR Newswire|About: DHRPR Newswire

SUNNYVALE, Calif., March 21, 2020 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2

 https://www.cepheid.com/coronavirus 

 https://www.cepheid.com/ 

 https://www.prnewswire.com/news-releases/cepheid-receives-emergency-use-authorization-from-fda-for-rapid-sars-cov-2-test-301027823.html 

 http://cepheid.mediaroom.com/2020-03-21-Cepheid-Receives-Emergency-Use-Authorization-from-FDA-for-Rapid-SARS-CoV-2-Test 

 https://seekingalpha.com/symbol/DHR 

Mon March 23, 2020 8:00 AM|PR Newswire|About: ABBV

PR Newswire

NORTH CHICAGO, Ill., March 23, 2020 /PRNewswire/ -- AbbVie (ABBV)

 November 21, 2018

 https://news.abbvie.com/news/press-releases/abbvie-receives-us-fda-accelerated-approval-for-venclexta-venetoclax-for-treatment-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm 

 https://news.abbvie.com/news/press-releases/abbvie-provides-update-from-phase-3-study-evaluating-venclexta-venetoclax-in-combination-with-low-dose-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-aml.htm 

 https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html 

 https://www.abbvie.com/ 

 https://news.abbvie.com/news/press-releases/abbvie-announces-positive-topline-results-from-phase-3-trial-venclexta-venetoclax-in-combination-with-azacitidine-in-patients-with-acute-myeloid-leukemia-aml.htm 

 https://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-3-trial-of-venclexta-venetoclax-in-combination-with-azacitidine-in-patients-with-acute-myeloid-leukemia-aml-301027968.html 

 https://seekingalpha.com/symbol/ABBV 

Thu March 19, 2020 6:00 AM|GlobeNewswire|About: CYDYGlobeNewswire

VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)

 https://www.cytodyn.com/ 

 https://www.cytodyn.com/pipeline 

 https://seekingalpha.com/symbol/CYDY 

Thu March 19, 2020 2:00 AM|Business Wire|About: CHGCY, RHHBY

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

 COVID-19 Response

Updated March 17, 2020

 https://www.gene.com/covid19 

 https://www.roche.com/media/releases/med-cor-2020-03-13.htm 

 https://www.actemra.com/ 

 https://www.gene.com/ 

 https://www.businesswire.com/news/home/20200318005822/en/ 

Wednesday, Mar 18, 2020

South San Francisco, CA -- March 18, 2020 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),

 https://www.gene.com/media/press-releases/14841/2020-03-18/genentech-initiates-phase-iii-clinical-t 

 https://seekingalpha.com/symbol/RHHBY 

 https://seekingalpha.com/symbol/CHGCY 

Wed March 18, 2020 6:00 PM|PR Newswire|About: ABT

PR Newswire

ABBOTT PARK, Ill., March 18, 2020 /PRNewswire/ -- Abbott (ABT) 

 https://www.abbott.com/ 

 https://www.prnewswire.com/news-releases/abbott-receives-fda-emergency-use-authorization-and-launches-test-to-detect-novel-coronavirus-301026501.html 

 https://seekingalpha.com/symbol/ABT 

Wed March 18, 2020 4:05 PM|Business Wire|About: DRNA

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

 https://dicerna.com/ 

 https://www.businesswire.com/news/home/20200318005712/en/ 

 https://seekingalpha.com/symbol/DRNA 

Thu March 19, 2020 2:40 PM|Business Wire|About: GILD

-- Pediatric approval of protease inhibitor-free, pan-genotypic, pan-fibrotic, once-daily regimen supports HCV elimination efforts by providing critical option for broad range of populations --

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

 https://www.gilead.com/ 

 https://www.businesswire.com/news/home/20200319005700/en/ 

 https://www.epclusa.com/ 

 https://seekingalpha.com/symbol/GILD 

 https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/us-food-and-drug-administration-approves-epclusa-sofosbuvirvelpatasvir-for-children-ages-6-and-older-or-weighing-at-least-17-kg-with-chronic-hep 

Thu March 19, 2020 3:15 PM|PR Newswire|About: CVS

WOONSOCKET, R.I., March 19, 2020 /PRNewswire/ -

 https://cvshealth.com/covid-19 

 https://www.prnewswire.com/news-releases/cvs-health-opens-covid-19-testing-site-in-massachusetts-301027097.html 

 https://seekingalpha.com/symbol/CVS 

PUBLISHED9 September 2019

 https://clinicaltrials.gov/ct2/show/NCT03043872?term=caspian&rank=1 

 https://seekingalpha.com/symbol/AZN 

03/16/2020Download PDFRecognition reinforces baricitinib's potential to be the first FDA-approved medicine for individuals living with alopecia areata

INDIANAPOLIS, March 16, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY)

 http://pi.lilly.com/us/olumiant-uspi.pdf 

 https://www.lilly.com/ 

 https://www.prnewswire.com/news-releases/lilly-receives-fda-breakthrough-therapy-designation-for-baricitinib-for-the-treatment-of-alopecia-areata-301024437.html 

 https://seekingalpha.com/symbol/LLY 

 https://seekingalpha.com/symbol/INCY 

Tue March 17, 2020 4:09 PM|Business Wire|About: QGEN

• Goal to reach global capacity for RNA nucleic extraction workflows for over 10 million patient tests a month by end of June 2020 and to reach capacity for 20 million monthly patient tests by end of 2020
• Welcomes FDA and CDC expansion of QIAGEN kits and instruments that can be used for RNA nucleic extraction step in workflows used for detection of SARS-CoV-2 coronavirus
• Anticipates CE-IVD clearance in coming days for SARS-CoV-2 Panel test for use on QIAstat-Dx syndromic testing, while working with FDA to gain emergency use authorization for United States

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

 https://www.businesswire.com/news/home/20200317005774/en/ 

 https://seekingalpha.com/symbol/QGEN 

 https://www.qiagen.com/us/ 

 https://www.qiagen.com/us/insights-magazine/a-rapid-response-to-covid-19?intcmp=atlas83 

Wed March 18, 2020 8:30 AM|GlobeNewswire|About: SLSGlobeNewswire

NEW YORK, March 18, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS)

 https://www.sellaslifesciences.com/Home/default.aspx 

 https://seekingalpha.com/symbol/SLS 

Wed March 18, 2020 6:30 AM|Business Wire|About: SAGE

Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study

Pursuing two additional pathways with the goal of accelerating patient access to zuranolone while continuing development for the episodic treatment of depression

Plans to pursue novel development and filing pathway for acute, rapid treatment of major depressive episodes when co-initiated with new antidepressant with one additional short-term pivotal study

Filing pathway for postpartum depression anticipated to require one additional study without long-term follow-up

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sage Therapeutics, Inc. (SAGE)

 https://www.sagerx.com/ 

 https://www.businesswire.com/news/home/20200318005176/en/ 

 https://www.sagerx.com/programs-research/pipeline/ 

March 18, 2020

20-valent pneumococcal conjugate vaccine demonstrated comparable safety and immunogenicity profile to licensed pneumococcal vaccines

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

 https://clinicaltrials.gov/ct2/show/NCT03828617?term=NCT03828617&draw=2&rank=1 

 https://www.pfizer.com/ 

 https://www.businesswire.com/news/ho

me/20200318005465/en/ 

 https://seekingalpha.com/symbol/PFE 

 23 Pfizer Inc. NCT03828617 Study Design. Available at www.clinicaltrials.gov under the identifier NCT03828617.
24 Pfizer Inc. NCT03835975 Study Design. Available at www.clinicaltrials.gov under the identifier NCT03835975. 

Tue March 17, 2020 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., March 17, 2020 /PRNewswire/ --

Regeneron has identified hundreds of virus-neutralizing antibodies; plans to initiate large-scale manufacturing by mid-April with antibody cocktail therapy

Potential to enter human clinical studies by early summer

This program is in addition to Regeneron's separate ongoing clinical program evaluating Kevzara® (sarilumab, an IL-6 receptor antibody) in severe COVID-19 patients

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

 https://newsroom.regeneron.com/news-releases/news-release-details/palm-ebola-clinical-trial-stopped-early-regenerons-regn-eb3 

 https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-begin-global-kevzarar-sarilumab-clinical 

 https://www.regeneron.com/ 

 https://www.prnewswire.com/news-releases/regeneron-announces-important-advances-in-novel-covid-19-antibody-program-301025247.html 

 https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-announces-important-advances-novel-covid-19-antibody 

 https://seekingalpha.com/symbol/REGN 

Mon March 16, 2020 8:06 PM|PR Newswire|About: BDXPR Newswire

FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala., March 16, 2020 /PRNewswire/ -- BD (Becton, Dickinson and Company (BDX)) (NYSE: BDX)

 https://www.bd.com/en-us 

 https://www.prnewswire.com/news-releases/bd-biogx-announce-fda-emergency-use-authorization-submissions-for-new-covid-19-diagnostics-for-use-in-us-301025209.html 

 https://seekingalpha.com/symbol/BDX 

Tue March 17, 2020 6:45 AM|Business Wire|About: MRK

Gefapixant (45 mg Twice Daily) Demonstrated Statistically Significant Decrease in 24-hour Coughs Per Hour Compared to Placebo at Week 12 and 24 in Phase 3 Trials

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

 https://www.merck.com/index.html 

 https://www.businesswire.com/news/home/20200317005183/en/ 

 https://seekingalpha.com/symbol/MRK 

 https://clinicaltrials.gov/ct2/show/NCT03449134?cond=chronic+cough&intr=gefapixant&lead=merck&phase=2&draw=2&rank=3 

 https://clinicaltrials.gov/ct2/show/NCT03449147?cond=chronic+cough&intr=gefapixant&lead=merck&phase=2&draw=2&rank=2 

Tue March 17, 2020 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, March 17, 2020 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

 http://www.mallinckrodt.com/ 

 https://www.prnewswire.com/news-releases/mallinckrodt-completes-rolling-submission-of-new-drug-application-to-the-us-food-and-drug-administration-fda-for-terlipressin-for-the-treatment-of-patients-with-hepatorenal-syndrome-type-1-hrs-1-301025237.html 

 https://seekingalpha.com/symbol/MNK 

. https://www.healthline.com/health/hepatorenal-syndrome 

Tue March 17, 2020 7:30 AM|GlobeNewswire|About: ABEO

Majority of potential study participants have been pre-screened

EB-101 successfully manufactured at Abeona and transplanted at Stanford University Medical Center

NEW YORK and CLEVELAND, March 17, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (ABEO)

 https://seekingalpha.com/symbol/ABEO 

Tue March 17, 2020 2:02 AM|GlobeNewswire|About: BNTX, PFE

• Companies will jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection
   
• Collaboration aims to accelerate global development of BNT162, leveraging expertise and resources of both companies
   
• Builds on 2018 agreement to jointly develop an mRNA-based influenza vaccine

NEW YORK and MAINZ, Germany, March 17, 2020 (GLOBE NEWSWIRE) -- Pfizer Inc. (PFE) and BioNTech SE (BNTX) 

 https://www.pfizer.com/ 

 https://biontech.de/ 

 https://biontech.de/science/pipeline 

 https://seekingalpha.com/symbol/BNTX 

 https://seekingalpha.com/symbol/PFE