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seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™ seeking biotech alpha 寻求生物技术阿尔法 4/7/2020 the heart of biotech™

Seeking Biotech Alpha APRIL/MARCH 2020 Insight

Vosoritide to Treat Children with Achondroplasia

Vosoritide to Treat Children with Achondroplasia

Vosoritide to Treat Children with Achondroplasia

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NUSTENDI™ (bempedoic acid and ezetimibe) Tablet

Vosoritide to Treat Children with Achondroplasia

Vosoritide to Treat Children with Achondroplasia

image131

 

Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia

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 

sacituzumab govitecan

Vosoritide to Treat Children with Achondroplasia

sacituzumab govitecan

image132

 

IMMUNOMEDICS ANNOUNCES ASCENT STUDY TO BE STOPPED FOR COMPELLING EFFICACY

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 


 

ASCENT Trial for Metastatic Triple-Negative Breast Cancer

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


 https://seekingalpha.com/symbol/IMMU 

ALUNBRIG® (brigatinib)

KEYTRUDA® (pembrolizumab) Injection, 100 mg

sacituzumab govitecan

image133

 

European Commission Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ NSCLC

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/ 


 

Alunbrig

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 



ARIES® SARS-CoV-2 Assay

KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA® (pembrolizumab) Injection, 100 mg

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Luminex Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

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 



KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA® (pembrolizumab) Injection, 100 mg

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Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type

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,


 

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

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


 https://www.merck.com/index.html 


 

Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

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 

 

Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type

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/ 



Seeking Biotech Alpha APRIL/MARCH 2020 Insight

RUXIENCE™ (rituximab)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

RUXIENCE™ (rituximab)

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Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab)

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 


 

PFIZER RECEIVES EUROPEAN APPROVAL FOR ONCOLOGY BIOSIMILAR, RUXIENCE™ (RITUXIMAB)

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 

Dupixent® (dupilumab)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

RUXIENCE™ (rituximab)

image137

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

image138

 

Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal

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 



Nucala (mepolizumab)

Reblozyl® (luspatercept-aamt)

oral prostacyclin pathway agents (PPAs), including UPTRAVI® (selexipag)

 

Glaxo's Nucala successful in pivotal nasal polyp study

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

Nucala (mepolizumab) is the first anti-IL5 biologic to report positive phase 3 results in patients with nasal polyps

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/
 

Effect of Mepolizumab in Severe Bilateral Nasal Polyps

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  

Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

image139

 

U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

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 




Ruxolitinib Cream

Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

image140

 


Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium

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 


 

TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

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


 

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

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

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


 https://seekingalpha.com/symbol/INCY 




Seeking Biotech Alpha APRIL/MARCH 2020 Insight

leronlimab (PRO 140)

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

image141

 

CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks

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 


 

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients

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 

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

image142

 

FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors

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 


 

FDA OKs new hemophilia treatment

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

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


 https://www.groupe-lfb.com/en/ 



KEYTRUDA ® (pembrolizumab) Injection, 100 mg

Sevenfact [coagulation factor VIIa (recombinant)-jncw]

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

 

Merck Announces KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival as First-Line Treatment for Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

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


 

Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)

 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 



Cologuard® Through Telehealth

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

KEYTRUDA ® (pembrolizumab) Injection, 100 mg

image143

 

Exact Sciences Highlights The Opportunity To Seek Screening With Cologuard® Through Telehealth

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 

PADCEV (enfortumab vedotin-ejfv), combined with Merck's Keytruda (pembrolizumab)

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

image144

 

Seattle Genetics Announces Potential Accelerated Approval Pathway in the U.S. for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

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 

 

Seattle Genetics' PADCEV may nab accelerated review for first-line urothelial cancer

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

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


 https://www.seattlegenetics.com/ 

 

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

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


 https://seekingalpha.com/symbol/SGEN 



Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

Kite & Teneobio Collaborate on Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb®

image145

 

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma

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 


 

NGS-based Discovery of UniAb® and UniDAb®

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

Seeking Biotech Alpha MARCH 2020 Insight

VASCEPA® (Icosapent Ethyl)

Idecabtagene Vicleucel (Ide-cel, bb2121)

XIFAXAN® (rifaximin) 550 mg tablets

image146

 

Amarin Highlights VASCEPA® (Icosapent Ethyl)-Related Data Presented at American College of Cardiology’s Annual Scientific Session Together With World Congress of Cardiology (ACC.20/WCC)

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 

XIFAXAN® (rifaximin) 550 mg tablets

Idecabtagene Vicleucel (Ide-cel, bb2121)

XIFAXAN® (rifaximin) 550 mg tablets

image147

 

Bausch Health Announces Favorable Topline Results From Study Evaluating Investigative Formulation of Rifaximin SSD IR to Treat Overt Hepatic Encephalopathy

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 

Idecabtagene Vicleucel (Ide-cel, bb2121)

Idecabtagene Vicleucel (Ide-cel, bb2121)

Idecabtagene Vicleucel (Ide-cel, bb2121)

 

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA

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 



ADCETRIS® (brentuximab vedotin)

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

Idecabtagene Vicleucel (Ide-cel, bb2121)

image148


Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) in Combination with CHP (Cyclophosphamide, Doxorubicin and Prednisone) for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma

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 






CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

image149

 

FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics

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

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


 https://seekingalpha.com/symbol/NTLA 


 

FDA signs off on study of CRISPR drug for sickle cell disease

Mar. 31, 2020 10:19 AM ET|About: Intellia Therapeutics,... (NTLA)|By: , 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 


remdesivir for the treatment of COVID-19

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate

 01-Apr-2020

GILEAD SCIENCES ANNOUNCES TWO PHASE 3 RANDOMISED STUDIES TO EVALUATE THE SAFETY AND ANTIVIRAL ACTIVITY OF REMDESIVIR (GS-5734™) IN PARTICIPANTS WITH MODERATE TO SEVERE COVID-19

  • 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


 

Gilead Sciences launches two remdesivir studies in UK

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

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

Seeking Biotech Alpha MARCH 2020 Insight

Evinacumab

NEXLETOL™ (bempedoic acid) Tablet

Taltz® (ixekizumab)

image150

 

Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

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 




NEXLETOL™ (bempedoic acid) Tablet

NEXLETOL™ (bempedoic acid) Tablet

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

image152

  

Esperion Announces Commercial Availability of the NEXLETOL™ (bempedoic acid) Tablet and Pledges a Conscientious Launch During Unprecedented Moment in Healthcare

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 

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, Detection of SARS-CoV-2 Coronavirus

image153

 

QIAGEN Receives U.S. FDA EUA for QIAstat-Dx test kit, First and Only Syndromic Solution Integrating Detection of SARS-CoV-2 Coronavirus

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 

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

image154

 

FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately

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 

EPIDIOLEX® (cannabidiol)

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

FDA clears CytoDyn’s mid-stage leronlimab trial for mild-to-moderately ill COVID-19 patients

image155

 

GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX® (cannabidiol) in the Treatment of Seizures Associated with Tuberous Sclerosis Complex

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 





Seeking Biotech Alpha MARCH 2020 Insight

BRILINTA

Dual-Antiplatelet Therapy

Imfinzi (durvalumab)

image156

 

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

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 

Imfinzi (durvalumab)

Dual-Antiplatelet Therapy

Imfinzi (durvalumab)

image157

 

Imfinzi approved in the US for extensive-stage small cell lung cancer

PUBLISHED30 March 2020

30 March 2020 07:00 BST
 

Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit in combination with etoposide and a choice of carboplatin or cisplatin chemotherapy
 

AstraZeneca’s Imfinzi (durvalumab


 https://www.astrazeneca.com/ 


 https://seekingalpha.com/symbol/AZN 


 

Our approach to Oncology

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

Dual-Antiplatelet Therapy

Dual-Antiplatelet Therapy

Dual-Antiplatelet Therapy

image158

 

Medtronic Onyx ONE Clear Study of One-Month Dual-Antiplatelet Therapy in High Bleeding Risk Stent Patients Beats Performance Goal

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 



soticlestat (OV935/TAK935)

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Dual-Antiplatelet Therapy

image159

 

Ovid Therapeutics Announces Initial Data with Soticlestat in CDKL5 Deficiency Disorder and Dup15q Syndrome

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 


 

A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Participants With 15Q Duplication Syndrome or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

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

 

A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy (Endymion)

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



Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

 

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

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 

VASCEPA® (Icosapent Ethyl)

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

Agilent Announces New Class 1 Triple Quadrupole LC/MS System

image160

 

Eicosapentaenoic Acid (EPA) Levels From VASCEPA® (Icosapent Ethyl) in REDUCE-IT® Strongly Correlated with Cardiovascular Outcomes

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 


 


Seeking Biotech Alpha MARCH 2020 Insight

Evolut™ transcatheter aortic valve replacement (TAVR) system

Evolut™ transcatheter aortic valve replacement (TAVR) system

Evolut™ transcatheter aortic valve replacement (TAVR) system

 

Medtronic Evolut TAVR System Demonstrates Excellent Outcomes in Study of Low-Risk Patients with Bicuspid Aortic Stenosis

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 




Symplicity Spyral™ Renal Denervation System

Evolut™ transcatheter aortic valve replacement (TAVR) system

Symplicity Spyral™ Renal Denervation System

image161

 

Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for Renal Denervation in Patients with High Blood Pressure Compared to Sham Procedure

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 


 

Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation (Symplicity AF)

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


 https://seekingalpha.com/symbol/MDT 

Kevzara® (sarilumab)

AXS-05, a novel, oral, investigational NMDA receptor antagonist

Symplicity Spyral™ Renal Denervation System

 

First patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19

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 



FARXIGA® (dapagliflozin) tablets

AXS-05, a novel, oral, investigational NMDA receptor antagonist

AXS-05, a novel, oral, investigational NMDA receptor antagonist

image163

Seeking Biotech Alpha MARCH 2020 Insight

ZEPOSIA® (ozanimod)

Zolgensma® (onasemnogene abeparvovec)

Zolgensma® (onasemnogene abeparvovec)

image164

 

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA® (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease

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 





Zolgensma® (onasemnogene abeparvovec)

Zolgensma® (onasemnogene abeparvovec)

Zolgensma® (onasemnogene abeparvovec)

image165

 

Zolgensmaonasemnogene abeparvovec 

 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). 


 

European advisory group backs Novartis gene therapy for SMA

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

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


 https://seekingalpha.com/symbol/NVS 



Cosentyx® (secukinumab)

Zolgensma® (onasemnogene abeparvovec)

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

image166

 

Novartis Cosentyx® gains positive CHMP opinion for new indication in the axial spondyloarthritis spectrum

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 

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

 

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes

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

- Test to run on Abbott's point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most

- ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings

- Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day

- This is the company's second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month

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 

 

Abbott Launches 5-Minute Virus Test for Use Almost Anywhere

By March 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 

vericiguat

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Repatha® (Evolocumab)

image167

  

Investigational Drug Vericiguat Significantly Reduced the Risk of the Composite Endpoint of Heart Failure Hospitalization or Cardiovascular Death, Compared to Placebo, When Given in Combination with Available Heart Failure Therapies

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 




Merck's vericiguat shows positive effect in large-scale CV outcomes study

Mar. 28, 2020 11:21 AM ET|About: Merck & Co., Inc. (MRK)|By: , 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 

Repatha® (Evolocumab)

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in Five Minutes

Repatha® (Evolocumab)

image168

Amgen Announces Positive Results At ACC.20/WCC From Phase 3B Study Of Repatha® (Evolocumab) In People Living With HIV Who Have High LDL-Cholesterol

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

Repatha is the First PCSK9 Inhibitor to Demonstrate LDL-C Lowering Results in People Living with HIV

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/ 



Seeking Biotech Alpha MARCH 2020 Insight

ZEPOSIA® (ozanimod)

Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

image169

 

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis

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 


 

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

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


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


 https://seekingalpha.com/symbol/BMY 



Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

Reblozyl® (luspatercept-aamt)

image170

 

New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia

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/ 


 

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia (BEYOND)

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


 

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Subjects Who Require Regular RBC Transfusions Due to Beta (β)-Thalassemia.

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


 

Efficacy and Safety Study of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions (COMMANDS)

 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 



Xofluza® (baloxavir marboxil)

Xofluza® (baloxavir marboxil)

Xofluza® (baloxavir marboxil)

image172

 

FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children

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 

leronlimab (PRO 140)

Xofluza® (baloxavir marboxil)

Sarclisa® (isatuximab)

image173

 

CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All COVID-19 Patients in Severe Condition Will be Filed Next Week per FDA Recommendation

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

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


 

Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

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 


Sarclisa® (isatuximab)

Xofluza® (baloxavir marboxil)

Sarclisa® (isatuximab)

image174

 

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

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/ 


Seeking Biotech Alpha MARCH 2020 Insight

CABOMETYX® (cabozantinib)

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

image175

 

Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma

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 

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

image176

 

Infinity Receives Fast Track Designation for IPI-549 in Combination with the Checkpoint Inhibitor Opdivo for the Treatment of Advanced Urothelial Cancer

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

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


 http://www.infi.com/ 


 

Infinity Receives Fast Track Designation for IPI-549 in Combination with the Checkpoint Inhibitor Opdivo for the Treatment of Advanced Urothelial Cancer

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 


 

Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

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


 https://seekingalpha.com/symbol/BMY 


 https://www.opdivo.com/ 

ABRAXANE® (nanoparticle albumin-bound paclitaxel)

IPI-549 in Combination with the Checkpoint Inhibitor Opdivo

Vir Biotechnology Proceeding with Two Clinical Development Candidates for COVID-19

image177

 

BeiGene Announces Supply Update for ABRAXANE® in China

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/ 


 

BeiGene reports Abraxane shortage in China

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

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

Vir Biotechnology Proceeding with Two Clinical Development Candidates for COVID-19

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

Vir Biotechnology Proceeding with Two Clinical Development Candidates for COVID-19

image178

 

Vir Biotechnology Proceeding with Two Clinical Development Candidates for COVID-19

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 



Xtend™ XmAb® Antibody Technology in Investigational Antibodies to Treat COVID-19

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

image179

 

Xencor and Vir Biotechnology Enter License Agreement for Use of Xtend™ XmAb® Antibody Technology in Investigational Antibodies to Treat COVID-19

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 

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

image180

 

Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

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

Company provides update on other designated approvals received to date

PR Newswire

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


 

Serving science in the battle against COVID-19

 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 



Seeking Biotech Alpha MARCH 2020 Insight

Actemra® (tocilizumab)

daptomycin 500mg injection and fosaprepitant 150mg

Actemra® (tocilizumab)

image181

 

Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

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 



Remdesivir (GS-5734)

daptomycin 500mg injection and fosaprepitant 150mg

Actemra® (tocilizumab)

daptomycin 500mg injection and fosaprepitant 150mg

daptomycin 500mg injection and fosaprepitant 150mg

daptomycin 500mg injection and fosaprepitant 150mg

image182

 

Sandoz acquires US distribution rights to two key hospital injectable medicines, reinforcing strategic focus on key growth segment

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

- Agreement expands company's injectables portfolio and hospital offerings, reinforcing strategic focus on this key growth segment

- BE Pharmaceuticals AG will retain manufacturing, regulatory responsibilities, and ANDA ownership

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/ 



EUCRISA® (crisaborole) ointment, 2%

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

daptomycin 500mg injection and fosaprepitant 150mg

image183

 

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 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/ 


 

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

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

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 

Ruxolitinib Cream in Atopic Dermatitis

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

image184

 

Data from Phase 3 TRuE-AD Trials of Ruxolitinib Cream in Atopic Dermatitis to be Presented at the 2020 Revolutionizing Atopic Dermatitis Virtual Conference

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 

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus

image185

 

QIAGEN Releases QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus Under New FDA Policy

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 

Seeking Biotech Alpha MARCH 2020 Insight

AXS-05 in Alzheimer’s Disease Agitation

STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

image186

 

Axsome Therapeutics Accelerates Completion of the ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer’s Disease Agitation

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 



STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

 

SORRENTO DEVELOPS STI-4398 (COVIDTRAP™ PROTEIN) FOR POTENTIAL PREVENTION AND TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

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/ 


 

SORRENTO DEVELOPS STI-4398 (COVIDTRAP™ PROTEIN) FOR POTENTIAL PREVENTION AND TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

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 

CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions)

STI-4398 (COVIDTRAP™ PROTEIN) FOR TREATMENT OF SARS-COV-2 CORONAVIRUS DISEASE (COVID-19)

CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions)

image187

 

ViiV Healthcare Announces First Global Regulatory Approval of CABENUVA; the First Complete, Long-acting, Regimen for the Treatment of HIV

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 




abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor

abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor

CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions)

 

Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch

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 


 

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare)

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


 https://www.pfizer.com/ 


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


 https://seekingalpha.com/symbol/PFE 



Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test

abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor

Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test

image188

 

Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

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 

VENCLEXTA® (venetoclax) in combination with azacitidine

abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor

Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test

image189

 

AbbVie Announces Positive Topline Results from Phase 3 Trial of VENCLEXTA® (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML)

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

- AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options [1],[2]

- Full results will be presented at a future medical meeting or published in a peer-reviewed journal

PR Newswire

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


 November 21, 2018

AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

 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 



Seeking Biotech Alpha MARCH 2020 Insight

leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor

image190

 

U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

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 

Actemra® (tocilizumab)

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor

image191

 

Genentech Initiates Phase III Clinical Trial of Actemra in Hospitalized Patients With Severe COVID-19 Pneumonia

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

GENENTECH COVID-19 RESPONSE

Updated March 17, 2020

 https://www.gene.com/covid19 


 

Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

 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

Genentech Initiates Phase III Clinical Trial Of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia

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 



Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

image192

 

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

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

- Abbott shipping 150,000 laboratory tests immediately; tests already sent to hospital and academic medical center labs in 18 states including Illinois, California, New York, Massachusetts and Washington

- Company scaling up production at its U.S. manufacturing location to reach capacity for 1 million tests per week by end of March

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 



DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency

DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency

Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

image193

 

Dicerna Receives Orphan Drug Designation From U.S. Food and Drug Administration for DCR-A1AT for Treatment of Alpha-1 Antitrypsin Deficiency

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 



Epclusa® (Sofosbuvir/Velpatasvir)

DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency

Epclusa® (Sofosbuvir/Velpatasvir)

image194

 

U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection

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 

COVID-19 resource center

DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency

Epclusa® (Sofosbuvir/Velpatasvir)

image195

 

CVS Health Opens COVID-19 Testing Site in Massachusetts

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

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


 

COVID-19 resource center

 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 




Seeking Biotech Alpha MARCH 2020 Insight

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

image196

 

Imfinzi is first immunotherapy to show both significant survival benefit and improved, durable responses in extensive-stage small cell lung cancer

PUBLISHED9 September 2019

9 September 2019 08:38 BST
 

In the Phase III CASPIAN trial Imfinzi at a fixed, convenient dose improved survival with either a cisplatin or carboplatin chemotherapy backbone

 

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) (CASPIAN)

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


 https://seekingalpha.com/symbol/AZN 



OLUMIANT® (baricitinib) 2-mg

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

image197

 

Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata

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 



RNA nucleic extraction

Imfinzi (durvalumab), combined with chemo (etoposide with either cisplatin or carboplatin)

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

image198

 

QIAGEN Dramatically Ramping Up Global Production Capacity for RNA Extraction Kits for Use in Detection of SARS-CoV-2 Coronavirus

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 

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

 

SELLAS Announces Positive Antigen-Specific Immune Response Data for Nelipepimut-S (NPS) in Women with Ductal Carcinoma In Situ (DCIS) of the Breast from Phase 2 VADIS Study

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 

Zuranolone (SAGE-217)

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

20-valent pneumococcal conjugate vaccine (20vPnC)

image199

 

Sage Therapeutics Announces Development Plan for Zuranolone (SAGE-217) Following Breakthrough Therapy Guidance Meeting with the U.S. Food & Drug Administration

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/ 

20-valent pneumococcal conjugate vaccine (20vPnC)

nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)

20-valent pneumococcal conjugate vaccine (20vPnC)

image200

 

PFIZER ANNOUNCES TOP-LINE RESULTS FROM PHASE 3 STUDY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS AGED 18 YEARS OR OLDER

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) 


 

Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

 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. 



Seeking Biotech Alpha MARCH 2020 Insight

Kevzara® (sarilumab, an IL-6 receptor antibody)

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist

Kevzara® (sarilumab, an IL-6 receptor antibody)

image201

 

Regeneron Announces Important Advances in Novel COVID-19 Antibody Program

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 




BD MAX™ Molecular Diagnostic Platform

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist

Kevzara® (sarilumab, an IL-6 receptor antibody)

image202

 

BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in U.S.

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 



Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist

Gefapixant is an investigational, orally administered, selective P2X3 receptor antagonist

image203

 

Merck Announces Top-Line Results from Phase 3 Trials Evaluating Gefapixant, an Investigational Treatment for Refractory or Unexplained Chronic Cough

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 


 

Phase 3 Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

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


 

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

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



EB-101 = gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)

EB-101 = gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)

EB-101 = gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)

image205

 

Abeona Therapeutics Announces First Patient Treated in Pivotal Phase III Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa

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 



Pfizer and BioNTech to Co-develop Potential COVID-19 Vaccine

EB-101 = gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)

EB-101 = gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)

image206

 

Pfizer and BioNTech to Co-develop Potential COVID-19 Vaccine

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