seeking biotech alpha April 2019 insight

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ViiV Healthcare's Juluca shows sustained treatment effect in studies

Apr. 3, 2019 7:45 AM ET|About: GlaxoSmithKline plc (GSK)|By: Mamta Mayani, SA News Editor  

BriaCell Announces Clinical Trial Collaboration Agreement with Incyte

Tue April 2, 2019 2:58 PM|GlobeNewswire|About: BCTXF, INCY, MRK

• BriaCell Therapeutics (BCTXF) and Incyte (INCY) have formed a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates
• Under the agreement, Incyte will provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT™, in advanced breast cancer patients

BERKELEY, Calif., and VANCOUVER, British Columbia, April 02, 2019 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF),

 Editas Medicine and BlueRock Therapeutics Enter Strategic Research Collaboration and Cross-Licensing Agreement to Combine Genome Editing and Cell Therapy Platforms

Wed April 3, 2019 7:00 AM|GlobeNewswire|About: EDIT

– Collaboration enables BlueRock to discover and develop engineered cell medicines broadly across neurology, cardiology and immunology –

– Collaboration enables Editas Medicine (EDIT) to discover and develop engineered cell medicines across oncology, including solid tumors and blood cancers –

CAMBRIDGE, Mass., April 03, 2019 (GLOBE NEWSWIRE) -- Editas Medicine, Inc.,

 http://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-and-bluerock-therapeutics-enter-strategic 

 https://bluerocktx.com/  

 VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Wed April 3, 2019 9:42 AM|Business Wire|About: PFE

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

 https://www.vizimpro.com/ 

BriaCell's Lead Candidate Combined With KEYTRUDA®: Strong Evidence of Rapid Additive or Synergistic Anti-Tumor Activity

Wed April 3, 2019 8:30 AM|GlobeNewswire|About: BCTXF, MRK 

AstraZeneca's Fasenra successful in mid-stage HES study

Apr. 4, 2019 7:21 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor  

 https://www.fasenra.com/ 

Roche's ipatasertib shows encouraging action in early-stage breast cancer study

Apr. 1, 2019 12:00 PM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor  

 https://www.tecentriq.com/ 

 https://www.abraxane.com/ 

Dynavax’s SD-101 and 4SC’s Domatinostat Demonstrate Synergy and Induce a Systemic Anti-tumor Response in Preclinical Models

Mon April 1, 2019 1:00 PM|GlobeNewswire|About: DVAX

BERKELEY, Calif. and PLANEGG-MARTINSRIED, Germany, April 01, 2019 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (DVAX)

Amgen (AMGN) Presents At Oppenheimer's 29th Annual Healthcare Conference - Slideshow

Apr. 1, 2019 1:34 PM ET | About: Amgen Inc. (AMGN) 

Bausch + Lomb Announces The U.S. Launch Of LOTEMAX® SM (Loteprednol Etabonate Ophthalmic Gel) 0.38% For The Treatment Of Postoperative Inflammation And Pain Following Ocular Surgery

Tue April 2, 2019 7:00 AM|PR Newswire|About: BHC

Shipments to U.S. Pharmaceutical Distributors Begin

BRIDGEWATER, N.J., April 2, 2019 /PRNewswire

Johnson & Johnson Announces Completion of Acquisition of Auris Health, Inc.

Mon April 1, 2019 4:30 PM|PR Newswire|About: JNJPR Newswire

NEW BRUNSWICK, N.J., April 1, 2019 /PRNewswire/ -- Johnson & Johnson (JNJ) announced today that Ethicon, Inc., has completed the acquisition of Auris Health, Inc. for approximately $3.4 billion in cash.

Clovis Oncology Announces Interim Results from Rubraca® (rucaparib) Phase 2 Study in Advanced Pancreatic Cancer and Nonclinical Data in Multiple Solid Tumor Types for Rucaparib and Lucitanib Presented at AACR 2019

Tue April 2, 2019 8:30 AM|Business Wire|About: CLVS 

 https://www.rubraca.com/ 

 https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2019/Clovis-Oncology-Announces-Interim-Results-from-Rubraca-rucaparib-Phase-2-Study-in-Advanced-Pancreatic-Cancer-and-Nonclinical-Data-in-Multiple-Solid-Tumor-Types-for-Rucaparib-and-Lucitanib-Presented-at-AACR-2019/default.aspx 

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

Mon April 1, 2019 6:55 AM|Business Wire|About: MRK

KEYTRUDA is First Anti-PD-1 Therapy to be Approved in Multiple Tumor Types in China

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

Selumetinib Granted U.S. Breakthrough Therapy Designation in Neurofibromatosis Type 1

Mon April 1, 2019 6:30 AM|Business Wire|About: MRK

Designation Based on Phase 2 SPRINT Trial in Pediatric Patients with NF1 Plexiform Neurofibromas

Selumetinib Is a MEK 1/2 Inhibitor Being Co-Developed by AstraZeneca and Merck (MRK)

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

Alkermes to Present New ALKS 3831 Data From ENLIGHTEN-2 and Interim Extension Safety Study Results at 2019 Congress of the Schizophrenia International Research Society

• Mon April 1, 2019 7:00 AM|PR Newswire|About: ALKS
• -- Poster Presentations to Highlight New Data on ARISTADA® and ALKS 3831 --

PR Newswire

DUBLIN, April 1, 2019 /PRNewswire/ -- Alkermes plc (ALKS) 

Salix Enters Into License Agreement With The University Of California To Develop And Commercialize Novel Compound For The Treatment Of Non-alcoholic Fatty Liver Disease And Non-alcoholic Steatohepatitis

Mon April 1, 2019 7:00 AM|PR Newswire|About: BHC

Investigational Treatment Demonstrated Promising Results in Preclinical Studies

BRIDGEWATER, N.J., April 1, 2019 /PRNewswire/

ADXS-PSA in Combination with KEYTRUDA® Prolonged Survival in Metastatic Castration-Resistant Prostate Cancer

Mon April 1, 2019 8:00 AM|Business Wire|About: ADXS

Updated Results from Phase 1/2 Study to be Presented Today at the AACR Annual Meeting

PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (ADXS)

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

European Medicines Agency Accepts Takeda’s Marketing Authorization Application for a Subcutaneous Formulation of Vedolizumab for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis and Crohn’s Disease

April 1, 2019 Osaka, JAPAN

• Additional treatment modality would provide greater choice in how patients receive gut-selective biologic vedolizumab
• Vedolizumab set to be the only maintenance therapy to offer the option of intravenous or subcutaneous formulations across ulcerative colitis and Crohn’s disease

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

bluebird bio Receives Positive Opinion from CHMP for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia (TDT) Who Do Not Have β0/β0 Genotype

Fri March 29, 2019 7:44 AM|Business Wire|About: BLUE 

 https://www.bluebirdbio.com/research-development/pipeline/ 

Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Fri March 29, 2019 8:00 AM|Business Wire|About: SGEN

-Phase 2 innovaTV 204 Trial Designed to Support Potential Accelerated Approval Pathway in U.S.-

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

 http://www.seattlegenetics.com/pipeline/tisotumab-vedotin 

 http://www.genmab.com/product-pipeline/products-in-development/humax-tf-adc 

Celgene Receives CHMP Positive Opinions for Both REVLIMID® (lenalidomide) and IMNOVID® (pomalidomide)-Based Triplet Combination Regimens for Patients with Multiple Myeloma

Fri March 29, 2019 8:12 AM|Business Wire|About: CELG 

 https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Receives-CHMP-Positive-Opinions-for-Both-REVLIMID-lenalidomide-and-IMNOVID-pomalidomide-Based-Triplet-Combination-Regimens-for-Patients-with-Multiple-Myeloma/default.aspx 

Viking Therapeutics to Participate in Upcoming Investor Conferences

Thu March 28, 2019 7:30 AM|PR Newswire|About: VKTX

SAN DIEGO, March 28, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (VKTX) 

European advisory group backs expanded use of Sanofi's Mozobil

Mar. 29, 2019 8:32 AM ET|About: Sanofi (SNY)|By: Douglas W. House, SA News Editor 

 Starboard pulls out of Celgene fight

Mar. 29, 2019 12:22 PM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor  

Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients

Thu March 28, 2019 5:04 PM|Business Wire|About: GILD, GLPG 

Neurocrine Biosciences and Voyager Therapeutics Announce Publication of Phase 1b Trial Results of VY-AADC for Parkinson’s Disease in the Annals of Neurology

Thu March 28, 2019 4:15 PM|GlobeNewswire|About: NBIX, VYGR

SAN DIEGO and CAMBRIDGE, Mass., March 28, 2019 (GLOBE NEWSWIRE) -- Neurocrine Biosciences, Inc. (NBIX) and Voyager Therapeutics, Inc. (VYGR) 

 Voyager Therapeutics, Inc. (VYGR)  

 https://www.voyagertherapeutics.com/  

Dynavax Announces European Medicines Agency Accepts Marketing Authorization Application for HEPLISAV-B® for Prevention of Hepatitis B in Adults

Thu March 28, 2019 4:05 PM|GlobeNewswire|About: DVAX

BERKELEY, Calif., March 28, 2019 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (DVAX)

 http://www.dynavax.com/our-pipeline/ 

 Basel, March 27, 2019   Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease

Mar 27, 2019

• Mayzent® (siponimod) is the first and only treatment specifically approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years[1]
   
• Up to 80% of patients with relapsing remitting MS (RRMS) will develop SPMS[2]; Mayzent addresses a critical unmet need for RRMS patients in transition and those with active SPMS who have transitioned 
   
• Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline[3]
   
• Mayzent is approved across the MS spectrum for clinically isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring a first dose observation

AstraZeneca leads in the development of a new International Life Science Innovation Park in China

PUBLISHED27 March 2019 

 Cluster to be built by the Wuxi municipal government and Wuxi High-tech District

AstraZeneca, Daiichi Sankyo ink $6.9B cancer deal

Mar. 29, 2019 3:33 AM ET|About: AstraZeneca PLC (AZN)|By: Yoel Minkoff, SA News Editor 

 https://www.daiichisankyo.com/rd/pipeline/pdf/20190131_Pipeline_EN.pdf  

 Bolstering its oncology push, AstraZeneca (NYSE:AZN) has struck a deal worth up to $6.9B to sell and develop Daiichi Sankyo's (OTCPK:DSNKY) promising new cancer drug. 

 Janssen Submits Application for DARZALEX® (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma

First DARZALEX combination treatment regimen being pursued in the frontline setting for transplant eligible patients with multiple myeloma

RARITAN, NJ, March 26, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson

Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019

Wed March 27, 2019 6:06 AM|Business Wire|About: GILD 

Johnson & Johnson Vision Announces Availability of ACUVUE OASYS with TRANSITIONS LIGHT INTELLIGENT TECHNOLOGY in the U.S.

Wed March 27, 2019 4:49 PM|PR Newswire|About: JNJPR Newswire

JACKSONVILLE, Fla., March 27, 2019 /PRNewswire/ -- Johnson & Johnson Vision 

Sarepta Therapeutics Announces Positive Expression Results from the Casimersen (SRP-4045) Arm of the ESSENCE Study

Thu March 28, 2019 8:30 AM|GlobeNewswire|About: SRPT 

 Janssen Submits Supplemental New Drug Application to U.S. FDA for INVOKANA®(canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes

If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care

Submission is based on data from the landmark Phase 3 CREDENCE renal outcomes study, which stopped early for positive efficacy findings

Raritan, N.J., March 28, 2019 

Seattle Genetics to Host Conference Call on Positive Topline Results from Pivotal Trial of Enfortumab Vedotin

Thu March 28, 2019 7:00 AM|Business Wire|About: SGEN

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

 http://www.seattlegenetics.com/pipeline/enfortumab-vedotin 

 https://seekingalpha.com/pr/17457684-seattle-genetics-astellas-announce-positive-topline-results-pivotal-trial-enfortumab-vedotin 

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Tue March 26, 2019 8:30 AM|Business Wire|About: GILD 

 https://www.biktarvy.com/ 

Illumina and the Lundbeck Foundation GeoGenetics Centre Collaborate to Generate One of the Largest Ancient Genome Datasets to Decode the Genetic Origins and Evolution of Mental Health Issues

Tue March 26, 2019 2:00 AM|Business Wire|About: ILMN 

Allergan Acquires Envy Medical, Inc., Adding Skin Resurfacing Dermalinfusion System to Best-in-Class Medical Aesthetics Portfolio

Tue March 26, 2019 9:00 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, March 26, 2019 /PRNewswire/ -- Allergan plc (AGN)

Johnson & Johnson Vision's Investigational Antihistamine-Releasing Contact Lens Demonstrates Positive Phase 3 Results

Tue March 26, 2019 8:00 AM|PR Newswire|About: JNJPR Newswire

JACKSONVILLE, Fla., March 26, 2019 /PRNewswire/ -- Johnson & Johnson 

Veracyte Announces New Afirma Xpression Atlas Data that Advance Genomic Understanding of Medullary Thyroid Cancer

Mon March 25, 2019 4:15 PM|Business Wire|About: VCYT 

 https://www.veracyte.com/our-products 

Oral semaglutide 7 mg and 14 mg doses showed superior reductions in blood sugar and weight compared to sitagliptin at 26 weeks in data presented at ENDO

Sat March 23, 2019 2:00 PM|PR Newswire|About: NONOF, NVO

NEW ORLEANS, March 23, 2019 /PRNewswire/ 

 Biogen and Eisai launch late-stage study of BAN2401 in Alzheimer's

Mar. 22, 2019 9:12 AM ET|About: Biogen Inc. (BIIB)|By: Douglas W. House, SA News Editor  

AstraZeneca's Forxiga OK'd in Europe for T1D

Mar. 25, 2019 7:04 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor  

 https://www.farxiga.com/ 

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Mon March 25, 2019 4:30 PM|Business Wire|About: CELG

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

AbbVie Announces First Regulatory Approval of SKYRIZI™ (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan

Tue March 26, 2019 1:00 AM|PR Newswire|About: ABBV 

BriaCell to Announce Early Efficacy Data of Lead Candidate in Combination with KEYTRUDA® at AACR Annual Meeting

Tue March 26, 2019 6:30 AM|GlobeNewswire|About: BCTXF, MRK 

 https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf 

Ichor Medical Systems Announces Collaboration and Research License Agreement with AstraZeneca to Develop DNA-based Monoclonal Antibody Platform

Tue March 26, 2019 7:00 AM|Business Wire|About: AZN

SAN DIEGO--(BUSINESS WIRE)-- Ichor® Medical Systems, Inc. (Ichor) 

 TriGrid® Delivery System. 

 British Columbia PharmaCare Lists AbbVie's Hepatitis C Treatment MAVIRET™ on its Formulary

Fri March 22, 2019 10:29 AM|Canada Newswire|About: ABBV 

J&J files European marketing application for expanded use of Darzalex

Mar. 22, 2019 8:22 AM ET|About: Celgene Corporation (CELG)|By: Douglas W. House, SA News Editor 

 Thermo Fisher Scientific to Acquire Brammer Bio, a Leader in Viral Vector Manufacturing

Sun March 24, 2019 8:30 PM|PR Newswire|About: TMO

Sarepta Therapeutics to Provide Update on Duchenne Muscular Dystrophy Gene Therapy Program

Mon March 25, 2019 7:30 AM|GlobeNewswire|About: SRPT 

Providence Cancer Institute to Present Findings on GR-MD-02 at the 2019 Keystone Symposia on Molecular and Cellular Biology

Fri March 22, 2019 10:19 AM|GlobeNewswire|About: GALT

NORCROSS, Ga., March 22, 2019 (GLOBE NEWSWIRE) -- Providence Cancer Institute and Galectin Therapeutics Inc. (GALT)

bluebird bio Opens State-of-the-Art Gene and Cell Therapy Manufacturing Facility in Durham, North Carolina

Fri March 22, 2019 8:00 AM|Business Wire|About: BLUE 

BriaCell Announces $2,000,000 Non-Brokered Private Placement Offering

Wed March 20, 2019 4:05 PM|GlobeNewswire|About: BCTXF, MRK

BERKELEY, Calif. and VANCOUVER, British Columbia, March 20, 2019 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (BCTXF) ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF)

Novocure Announces 48 Presentations and a Symposium Session on Tumor Treating Fields at the American Association for Cancer Research Annual Meeting 2019

Thu March 21, 2019 7:30 AM|Business Wire|About: NVCR 

Abiomed reports 6% stake in ShockWave Medical

Mar. 21, 2019 6:55 AM ET|About: ABIOMED, Inc. (ABMD)|By: Douglas W. House, SA News Editor  

https://shockwavemedical.com/?country=United%20States

Viking Therapeutics (VKTX) Investor Presentation - Slideshow

Mar. 21, 2019 3:12 PM ET | About: Viking Therapeutics, Inc. (VKTX) 

Sorrento Therapeutics (SRNE) Presents At Oppenheimer 29th Annual Healthcare Conference - Slideshow

Mar. 21, 2019 2:29 PM ET|1 comment | About: Sorrento Therapeutics, Inc. (SRNE) 

Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer

Fri March 22, 2019 7:30 AM|Business Wire|About: NVCR

INNOVATE-3

https://www.novocure.com/novocure-initiates-phase-3-pivotal-trial-in-recurrent-ovarian-cancer/

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics

Wed March 20, 2019 6:45 AM|Business Wire|About: PFE 

Merck and NGM Bio Announce Extension of Broad, Multi-Year Strategic Collaboration to 2022

Wed March 20, 2019 6:30 AM|Business Wire|About: MRK 

Novo files two U.S. applications for oral semaglutide

Mar. 20, 2019 11:07 AM ET|About: Novo Nordisk A/S (NVO)|By: Douglas W. House, SA News Editor  

Alexion and Affibody Announce Partnership to Co-Develop Anti-FcRn Affibody® Molecule

Wed March 20, 2019 6:30 AM|Business Wire|About: ALXN 

Alexion and Zealand Pharma Announce Collaboration to Discover and Develop Peptide Therapies for Complement-Mediated Diseases

Wed March 20, 2019 7:00 AM|Business Wire|About: ALXN, ZEAL 

NCCN Announces Six Quality Improvement Projects in Gastric Cancer Care Approved for Collaboration with Lilly Oncology

Wed March 20, 2019 8:45 AM|PR Newswire|About: LLY

PLYMOUTH MEETING, Pa. and INDIANAPOLIS, March 20, 2019 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) and Eli Lilly and Company (LLY) 

Abbott Announces CE Mark for Alinity™ m Diagnostics System and Assays, the Latest in Molecular Technology, to Help Deliver Critical Test Results and Benefits to Patients

Tue March 19, 2019 8:00 AM|PR Newswire|About: ABT 

https://www.abbott.com/corpnewsroom/product-and-innovation/new-systems-to-help-improve-patient-care.html

Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

- Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older -

DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN

 New Treatment Option Now Available in Canada for Newly Diagnosed Patients with Advanced Lung Cancer

Mon March 18, 2019 8:00 AM|Canada Newswire|About: MRK 

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html

Abbott's next-gen LVAD shows treatment benefit in comparative study

Mar. 18, 2019 10:32 AM ET|About: Abbott Laboratories (ABT)|By: Douglas W. House, SA News Editor 

 Impella RP Post-Approval Study Data Presented at ACC 2019

Mon March 18, 2019 7:00 AM|Business Wire|About: ABMD 

 NEW ORLEANS, La.--(BUSINESS WIRE)-- Abiomed (NASDAQ:ABMD) 

http://www.abiomed.com/impella/impella-rp

Sage Therapeutics Announces FDA Approval of ZULRESSO™ (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression

Tue March 19, 2019 7:00 PM|Business Wire|About: SAGE 

First Sub-Analyses from the DECLARE-TIMI 58 Trial Further Support the Cardiovascular Effects of FARXIGA in Type 2 Diabetes

Mon March 18, 2019 9:01 AM|Business Wire|About: AZN 

BRAFTOVI® (encorafenib) in Combination with MEKTOVI® (binimetinib) and ERBITUX® (cetuximab) or panitumumab Recommended by the National Comprehensive Cancer Network® (NCCN) Guidelines as a Treatment Option for Patients with Advanced BRAF-mutant Colorectal Cancer

Mon March 18, 2019 8:00 AM|PR Newswire|About: ARRY

BOULDER, Colo., March 18, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY) 

https://www.braftovimektovi.com/

Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

Mon March 18, 2019 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (AGN)

FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer

Mon March 18, 2019 9:15 PM|Business Wire|About: RHHBY 

AbbVie Provides Update on VENCLEXTA®/VENCLYXTO® (venetoclax) Multiple Myeloma Program

Tue March 19, 2019 8:45 AM|PR Newswire|About: ABBV

NORTH CHICAGO, Ill., March 19, 2019 /PRNewswire/ -- AbbVie (ABBV)

https://www.venclexta.com/

US FDA grants saracatinib Orphan Drug Designation for idiopathic pulmonary fibrosis  

18 March 2019 07:00 GMT

 AstraZeneca PLC (AZN) 

New Late-Breaking Analyses from Landmark COAPT™ Trial Show Benefits of Abbott's MitraClip™ Device

Sun March 17, 2019 9:00 AM|PR Newswire|About: ABT 

 Late-breaking Clinical Trial Highlights Positive Safety and Efficacy Data for the LUMINIZE™ RF Balloon Catheter

Sun March 17, 2019 11:00 AM|PR Newswire|About: BSX 

Clovis Oncology to Highlight Rubraca® (rucaparib) Data from Post-Hoc ARIEL3 Analyses at SGO 2019 Congress

Sat March 16, 2019 12:45 PM|Business Wire|About: CLVS 

https://www.rubraca.com/

 Novocure to Participate in Oppenheimer’s 29th Annual Healthcare Conference

Mon March 18, 2019 7:30 AM|Business Wire|About: NVCR

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

Novocure (NASDAQ:NVCR) 

AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention

Sun March 17, 2019 11:45 AM|Business Wire|About: BMY, PFE 

https://www.eliquis.bmscustomerconnect.com/

Stryker acquires OrthoSpace, Ltd.

03/14/2019

Kalamazoo, Michigan, March 14, 2019 (GLOBE NEWSWIRE) -- Stryker (NYSE:SYK) announced today it has completed the acquisition of OrthoSpace, Ltd., a privately held company founded in 2009 and headquartered in Caesarea, Israel, in an all cash transaction for an upfront payment of $110 million and future milestone payments of up to an additional $110 million.

Abbott Receives FDA Approval for Expanded Indication for MitraClip™ Device

Thu March 14, 2019 1:52 PM|PR Newswire|About: ABT 

Amgen Announces New Four-Year Outcomes Study To Examine Long-Term Effects Of Repatha® (evolocumab) In High-Risk Cardiovascular Disease (CVD) Patients Without Prior Heart Attack Or Stroke

Fri March 15, 2019 4:00 PM|PR Newswire|About: AMGN 

Praluent® (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease

Fri March 15, 2019 7:40 PM|GlobeNewswire|About: SNY

France, March 16, 2019 (GLOBE NEWSWIRE)

 Interim Analysis Showed Treatment with OPSUMIT® (macitentan) Associated with Significant Improvement in Right Ventricular (RV) Function and Pulmonary Vascular Resistance (PVR) in Patients with Pulmonary Arterial Hypertension (PAH)

Fri March 15, 2019 9:00 AM|PR Newswire|About: JNJPR Newswire

SOUTH SAN FRANCISCO, Calif. and ALLSCHWIL, Switzerland, March 15, 2019 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)

https://www1.actelion.us/us/products/index.page?

U.S. FDA Clears da Vinci SP for Certain Transoral Otolaryngology Procedures

Fri March 15, 2019 1:36 PM|GlobeNewswire|About: ISRGGlobeNewswire

SUNNYVALE, Calif., March 15, 2019 (GLOBE NEWSWIRE) -- Intuitive (ISRG)

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

Basel, 15 March 2019

European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease

• MabThera is the first biologic treatment approved for moderate to severe cases of the rare autoimmune disease pemphigus vulgaris (PV), and the first major advancement in the treatment of the disease in more than 60 years
• PV is a rare and potentially life-threatening blistering condition which can cause severe pain and disfigurement
• MabThera is now approved in Europe to treat four autoimmune diseases

Roche (SIX: RO, ROG; OTCQX: RHHBY)

Boston Scientific Receives CE Mark for Next Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

Wed March 13, 2019 7:00 AM|PR Newswire|About: BSXPR Newswire

MARLBOROUGH, Mass., March 13, 2019 /PRNewswire/ -- Boston Scientific Corporation (BSX) 

Regeneron and Sanofi to Present New Praluent® (alirocumab) Data at ACC.19

Wed March 13, 2019 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and BRIDGEWATER, N.J., March 13, 2019 /PRNewswire/

 Hemispherx Bio up 8% on Ampligen progress

Mar. 13, 2019 10:39 AM ET|About: Hemispherx Biopharma, ... (HEB)|By: Douglas W. House, SA News Editor  

Chugai’s Hemlibra Receives Approval for Severe Hemophilia A Without Factor VIII Inhibitors from the European Commission

Thu March 14, 2019 2:00 AM|Business Wire|About: CHGCY, RHHBY 

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Thu March 14, 2019 6:45 AM|Business Wire|About: MRK 

BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease

Thu March 14, 2019 6:59 AM|PR Newswire|About: BDXPR Newswire

FRANKLIN LAKES, N.J., March 14, 2019 /PRNewswire/ -- BD (Becton, Dickinson and Company (BDX)) (NYSE: BDX)

Johnson & Johnson files U.S. marketing application for expanded use of Darzalex

Mar. 12, 2019 4:52 PM ET|About: Celgene Corporation (CELG)|By: Douglas W. House, SA News Editor  

Celgene Provides Update on ABRAXANE® Combination Therapy in the Treatment of Metastatic Triple-Negative Breast Cancer and Pancreatic Cancer

Tue March 12, 2019 4:30 PM|Business Wire|About: CELG 

https://www.tecentriq.com/

https://www.abraxane.com/

FDA OKs new generic version of Novartis' Diovan

Mar. 12, 2019 3:56 PM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor  

Editas Medicine (EDIT) Investor Presentation - Slideshow

Mar. 12, 2019 3:52 PM ET | About: Editas Medicine, Inc. (EDIT) 

Princeton faculty to test new Microsoft Station B platform toward goal of boosting production of lifesaving biological therapies

by the Office of CommunicationsMarch 12, 2019 9:19 a.m. 

https://www.microsoft.com/en-us/research/project/stationb/

Teen Scientists Win $1.8 Million at Regeneron Science Talent Search 2019 with Innovative Ideas on Exoplanets, HIV and a Classic Math Problem

Tue March 12, 2019 9:56 PM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and WASHINGTON, March 12, 2019 /PRNewswire/

U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA™ (trastuzumab-qyyp), a Biosimilar to Herceptin®1

Mon March 11, 2019 7:37 PM|Business Wire|About: PFE

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

Lilly's CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Tue March 12, 2019 6:45 AM|PR Newswire|About: LLY 

Vertex Receives Approval for SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) in Australia, to Treat the Underlying Cause of Cystic Fibrosis in People aged 12 and Older with Certain CFTR Gene Mutations

Tue March 12, 2019 5:07 AM|Business Wire|About: VRTX 

Neurocrine Biosciences Reports Positive Interim Results from Phase II Study of NBI-74788 in Adults with Classic Congenital Adrenal Hyperplasia

Tue March 12, 2019 8:00 AM|PR Newswire|About: NBIX 

https://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-positive-interim-results-from-phase-ii-study-of-nbi-74788-in-adults-with-classic-congenital-adrenal-hyperplasia-300810480.html

FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents

Mon March 11, 2019 3:45 PM|PR Newswire|About: REGN, SNY

* In a Phase 3 trial, Dupixent significantly reduced the extent and severity of disease and itching, and helped adolescents achieve clearer skin

PR Newswire

CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/

Microsoft researchers have spent years studying those underlying processes and learning how to influence them. Now they are launching collaborations with Princeton University and UK-based companies Oxford Biomedica and Synthace to develop and test an integrated platform that’s designed to help other companies and research teams perform that work more reliably. The goal: To reduce the amount of trial and error required to make beneficial scientific breakthroughs and enable companies and academic researchers already established in the field to operate more efficiently and cost-effectively.

The project, called Station B, aims to develop an end-to-end platform — including a software stack, a means to automate lab experiments and machine learning methods that run in the cloud on Microsoft Azure — to help scientists more efficiently and predictably channel the power of life’s ultimate information processing machines: living cells.

Jennifer Langston

Mar 11, 2019

CAMBRIDGE, United Kingdom – In recent years, companies have figured out how to engineer bacteria to make cement, helping reduce the pollution involved in traditional manufacturing. Using more advanced techniques, scientists have even programmed patients’ immune cells to recognize and kill leukemia cells, giving children who had virtually no chance of survival years of prolonged life.

Bristol-Myers sends open letter to shareholders supporting rationale for Celgene merger

Mar. 6, 2019 7:17 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor  

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-files-investor-presentation-and-board-dir

FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Fri March 8, 2019 12:06 PM|Business Wire|About: RHHBY 

https://www.abraxane.com/

https://www.tecentriq-hcp.com/

Medtronic Announces Cash Dividend for Fourth Quarter of Fiscal Year 2019

Fri March 8, 2019 4:30 PM|InPublic US|About: MDT

Board Authorizes $6 Billion for Share Repurchases

DUBLIN - March 8, 2018 - The board of directors of Medtronic plc (MDT)

Celgene Submits Application to EMA for Ozanimod for the Treatment of Relapsing-Remitting Multiple Sclerosis

Mon March 11, 2019 7:30 AM|Business Wire|About: CELG

New Drug Application submission to U.S. FDA on track for end of March

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

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine

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

Allergan Continues to Expand Its Leading Migraine Portfolio Across the Spectrum of the Disease from Episodic to Chronic -

PR Newswire

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

Seres teams up with AstraZeneca in cancer; shares up 17%

Mar. 11, 2019 9:48 AM ET|About: Seres Therapeutics, Inc. (MCRB)|By: Douglas W. House, SA News Editor  

 Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies

Thu March 7, 2019 5:30 PM|Business Wire|About: GILD

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

FDA to Undertake Priority Review of Dupixent® (dupilumab) for Adults with Inadequately Controlled Severe Chronic Rhinosinusitis with Nasal Polyps

Fri March 8, 2019 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, March 8, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi

Roche's Tecentriq + Avastin OK'd in Europe for first-line lung cancer

Mar. 8, 2019 7:11 AM ET|About: Roche Holding Ltd ADR (RHHBY)|By: Douglas W. House, SA News Editor  

https://www.tecentriq-hcp.com/nsclc.html

https://www.avastin.com/patient/mcrc.html

Sangamo Therapeutics Announces Publication Of Data Demonstrating New Zinc Finger Nuclease Architectures Enabling High-Precision Genome Editing

Fri March 8, 2019 5:00 AM|PR Newswire|About: SGMO 

Bayer files European application for darolutamide for prostate cancer

Mar. 8, 2019 7:02 AM ET|About: Bayer A.G. ADR (BAYRY)|By: Douglas W. House, SA News Editor 

Alexion Announces Publication of Interim Data from Phase 3 Open-Label Extension Study Supporting Long-Term Efficacy and Safety of SOLIRIS® (Eculizumab) in Adult Patients with Generalized Myasthenia Gravis in Muscle & Nerve

Fri March 8, 2019 9:05 AM|Business Wire|About: ALXN