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seeking biotech alpha

seeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotech

seeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotechseeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotech

seeking biotech alpha April 2019 insight

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

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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  

JULUCA is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

BriaCell Therapeutics (BCTXF) and Incyte (INCY)

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

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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),

BriaCell Announces Clinical Trial Collaboration Agreement with Incyte POSTED ON APRIL 2, 2019 BY FARRAH DEAN · BriaCell Therapeutics and Incyte 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 2, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF)

Editas Medicine and BlueRock Therapeutics Enter Strategic Research Collaboration

ViiV Healthcare, HIV-focused joint venture = GlaxoSmithKline (GSK), Pfizer (PFE) & Shionogi (SGIOY)

Editas Medicine and BlueRock Therapeutics Enter Strategic Research Collaboration

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 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/  

We are working to translate the promise of genome editing into a broad class of genomic medicine that have the potential to transform lives. Our research is still in the early stages. We hope you will use this website to learn more about genome editing, CRISPR and our areas of focus that might be useful.

VIZIMPRO® (dacomitinib)

Bria-IMT™ in combination with KEYTRUDA®

Editas Medicine and BlueRock Therapeutics Enter Strategic Research Collaboration

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 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/ 

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 Wednesday, April 3, 2019 - 9:42am EDT Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Bria-IMT™ in combination with KEYTRUDA®

Bria-IMT™ in combination with KEYTRUDA®

Bria-IMT™ in combination with KEYTRUDA®

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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 

BriaCell’s Lead Candidate Combined With KEYTRUDA®: Strong Evidence of Rapid Additive or Synergistic Anti-Tumor Activity POSTED ON APRIL 3, 2019 BY FARRAH DEAN • As presented at the American Association for Cancer Research (AACR) annual meeting: early efficacy data for the first six advanced breast cancer patients dosed with Bria-IMT™ in combination with KEYTRUDA® suggest additive or synergistic effects on tumor regression (“shrinkage”). • Findings support BriaCell’s hypothesis: KEYTRUDA® acts by “awakening” a component of the immune system, while Bria-IMT™ “puts the foot on the gas” of the immune system, leading to more powerful anti-tumor activity. • The combination with KEYTRUDA® appears to overcome the limitation of requiring patients to have an HLA match with Bria-IMT™. • Excellent overall safety profile for the combination. BERKELEY, Calif., and VANCOUVER, British Columbia, April 3, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF)

Fasenra (benralizumab)

Bria-IMT™ in combination with KEYTRUDA®

Bria-IMT™ in combination with KEYTRUDA®

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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/ 

Positive results from Fasenra Phase II trial in hypereosinophilic syndrome published in New England Journal of Medicine PUBLISHED 4 April 2019

seeking biotech alpha April 2019 insight

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

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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/ 


Basel, 01 April 2019 Roche’s ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial Data from Phase Ib study to be presented at American Association for Cancer Research (AACR) 2019 annual congress 73% overall response rate (ORR) irrespective of PD-L1 status or PI3KCA/AKT1/PTEN alteration status Roche (SIX: RO, ROG; OTCQX: RHHBY)

intratumoral TLR9 agonist SD-101 induced a systemic anti-tumoral immune response

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

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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)

Dynavax Technologies Corporation, Berkeley, CA April 1, 2019, 1:00 PM - 5:00 PM Session PO.CL06.05 - Combination Immunotherapies 1 2259 / 18 - Tumor abscopal responses induced by the TLR9 agonist, SD-101, are strongly potentiated by a HDAC class I inhibitor, domatinostat

Amgen Inc. (AMGN)

combination of ipatasertib, Tecentriq (atezolizumab) & Abraxane (paclitaxel albumin-bound particles

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

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

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

The product information provided below is intended for residents of the U.S. only. For information in other countries, please select your country from the "Amgen Worldwide" menu above.

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

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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

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 NEWS PROVIDED BY Bausch Health Companies Inc. Apr 02, 2019, 07:00 ET BRIDGEWATER, N.J., April 2, 2019 /PRNewswire/

Johnson & Johnson (JNJ)

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

Johnson & Johnson (JNJ)

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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.

Johnson & Johnson Announces Completion of Acquisition of Auris Health, Inc. Auris will Enable Johnson & Johnson to Deliver on the Promise of Digital Surgery and Drive Better Outcomes for Patients NEWS PROVIDED BY Johnson & Johnson Apr 01, 2019, 16:30 ET NEW BRUNSWICK, N.J., April 1, 2019 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)

Rubraca® (rucaparib)

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%

Johnson & Johnson (JNJ)

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 

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 Interim data from an investigator-initiated study in first-line maintenance setting for advanced pancreatic cancer suggest that Rubraca provides disease control with no new safety signals in 19 evaluable platinum-sensitive patients with germline BRCA1, germline or somatic BRCA2, or germline PALB2 mutations Clovis is evaluating a potential clinical and regulatory path forward for Rubraca in pancreatic cancer Nonclinical studies of rucaparib and lucitanib in multiple solid tumor types and Rubraca Trials in Progress posters also presented at AACR 2019 April 02, 2019 08:30 AM Eastern Daylight Time BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS)

seeking biotech alpha April 2019 insight

KEYTRUDA® (pembrolizumab)

ALKS 3831 (olanzapine/samidorphan)

MEK 1/2 inhibitor selumetinib.

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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),

Merck’s KEYTRUDA® (pembrolizumab) Approved in China for First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy KEYTRUDA is First Anti-PD-1 Therapy to be Approved in Multiple Tumor Types in China Monday, April 1, 2019 6:55 am EDT PDFPrint KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK)

MEK 1/2 inhibitor selumetinib.

ALKS 3831 (olanzapine/samidorphan)

MEK 1/2 inhibitor selumetinib.

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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


Selumetinib Granted U.S. Breakthrough Therapy Designation in Neurofibromatosis Type 1 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 April 01, 2019 06:30 AM Eastern Daylight Time KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK)

ALKS 3831 (olanzapine/samidorphan)

ALKS 3831 (olanzapine/samidorphan)

Bausch Health Companies Inc. (BHC) and UCLA's Technology Development Group

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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) 

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 -- Company to Host Investor Conference Call at 8:00 a.m. ET on Friday, April 12 -- -- Poster Presentations to Highlight New Data on ARISTADA® and ALKS 3831 -- NEWS PROVIDED BY Alkermes plc Apr 01, 2019, 07:00 ET DUBLIN, April 1, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

Bausch Health Companies Inc. (BHC) and UCLA's Technology Development Group

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

Bausch Health Companies Inc. (BHC) and UCLA's Technology Development Group

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/

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 NEWS PROVIDED BY Bausch Health Companies Inc. Apr 01, 2019, 07:00 ET Investigational Treatment Demonstrated Promising Results in Preclinical Studies BRIDGEWATER, N.J., April 1, 2019 /PRNewswire/

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

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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/ 

ADXS-PSA In Combination With KEYTRUDA® Prolonged Survival In Metastatic Castration-Resistant Prostate Cancer April 1, 2019 EmailPDFPrintRSS PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ: ADXS),

investigational subcutaneous (SC) formulation of vedolizumab -Entyvio® (vedolizumab)

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

ADXS-PSA, Listeria monocytogenes (Lm)-based immunotherapies, with KEYTRUDA® (pembrolizumab)

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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”)

Uses of ENTYVIO® (vedolizumab) ENTYVIO is a prescription medicine used in adults: with moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider. with moderate to severe Crohn's disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.

seeking biotech alpha March 2019 insight

ZYNTEGLO™ (autologous CD34+ cells encoding β A-T87Q-globin gene)

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

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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/ 

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 First gene therapy recommended for approval in the EU for TDT Treatment with ZYNTEGLO has been shown to help eliminate the need for chronic blood transfusions in patients with TDT ZYNTEGLO is bluebird bio’s first gene therapy submitted for regulatory approval CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 29, 2019-- bluebird bio, Inc. (Nasdaq:BLUE)

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

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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 

Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer -Phase 2 innovaTV 204 Trial Designed to Support Potential Accelerated Approval Pathway in U.S.- March 29, 2019 08:00 AM Eastern Daylight Time BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN

REVLIMID (lenalidomide) and IMNOVID (pomalidomide).

tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer

REVLIMID (lenalidomide) and IMNOVID (pomalidomide).

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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 

Celgene Receives CHMP Positive Opinions for Both REVLIMID® (lenalidomide) and IMNOVID® (pomalidomide)-Based Triplet Combination Regimens for Patients with Multiple Myeloma The CHMP adopted two positive opinions recommending European Commission approval of: REVLIMID in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant IMNOVID in combination with bortezomib and dexamethasone (PVd), for adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide March 29, 2019 08:12 AM Eastern Daylight Time SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG)

Viking Therapeutics, Inc. (VKTX)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

REVLIMID (lenalidomide) and IMNOVID (pomalidomide).

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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) 

We have a pipeline of novel, first-in-class or best-in-class drug candidates for the treatment of metabolic and endocrine disorders

Mozobil (plerixafor injection)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

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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 

Mozobil is approved by the FDA to be used in combination with another agent (granulocyte‑colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients living with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

Bristol-Myers Squibb's (BMY) $74B takeover of Celgene (CELG)

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 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  

Independent Proxy Advisory Firms ISS and Glass Lewis Recommend Bristol-Myers Squibb Shareholders Vote “FOR” Proposed Merger with Celgene Fri March 29, 2019 11:13 AM|Business Wire|About: BMY, CELG Bristol-Myers Squibb Urges Shareholders to Vote “FOR” the Merger-Related Proposals on the WHITE Proxy Card Today

seeking biotech alpha March 2019 insight

filgotinib, an investigational, oral, selective JAK1 inhibitor

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

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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 

Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients -- Filgotinib 100 mg and 200 mg Plus Methotrexate (MTX) Demonstrated Significantly Higher ACR20/50/70 Responses Than Methotrexate Alone -- -- Filgotinib Safety Profile Consistent With Previously Reported Results -- March 28, 2019 05:04 PM Eastern Daylight Time FOSTER CITY, Calif. and MECHELEN, Belgium--(BUSINESS WIRE)--regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG)

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

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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/  

Neurocrine Biosciences and Voyager Therapeutics Announce Publication of Phase 1b Trial Results of VY-AADC for Parkinson’s Disease in the Annals of Neurology SAN DIEGO and CAMBRIDGE, Mass., March 28, 2019 (GLOBE NEWSWIRE) -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) and Voyager Therapeutics, Inc. (NASDAQ: VYGR)

HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]

VY-AADC, an investigational gene therapy treatment for Parkinson’s disease

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

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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/ 

Mar 28, 2019 Back PDF Version Dynavax Announces European Medicines Agency Accepts Marketing Authorization Application for HEPLISAV-B® for Prevention of Hepatitis B in Adults BERKELEY, Calif., March 28, 2019 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX)

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

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 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 is spearheading the creation of a new life sciences park, in Wuxi, China

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

AstraZeneca is spearheading the creation of a new life sciences park, in Wuxi, China

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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

阿斯利康中国

AstraZeneca PLC (AZN) & Daiichi Sankyo's (OTCPK:DSNKY)

Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis

AstraZeneca is spearheading the creation of a new life sciences park, in Wuxi, China

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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. 

AstraZeneca and Daiichi Sankyo enter collaboration for novel HER2-targeting antibody-drug conjugate PUBLISHED 28 March 2019 Companies to accelerate and expand development of trastuzumab deruxtecan across breast and other cancers, with the potential to redefine standard of care Funding via an equity placement of approximately $3.5bn Guidance for 2019 Core Earnings Per Share remains unchanged; growing accretion from 2020 to a significant contribution in 2023

seeking biotech alpha March 2019 insight

DARZALEX (daratumumab)

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

image693

 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

WHAT IS DARZALEX® (daratumumab)? DARZALEX® is a prescription medicine used to treat multiple myeloma: In combination with the medicines bortezomib, melphalan and prednisone, in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant). In combination with the medicines lenalidomide and dexamethasone or bortezomib and dexamethasone, in people who have received at least one prior medicine to treat multiple myeloma. In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor. Alone in people who have received at least three prior medicines to treat multiple myeloma, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent.

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

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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 

Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 -- More Than 35 Abstracts Across NASH, PSC and Viral Hepatitis Reflect Ongoing Commitment to Advancing Liver Disease Research and Patient Care -- March 27, 2019 06:06 AM Eastern Daylight Time FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD)

ACUVUE OASYS with TRANSITIONS LIGHT INTELLIGENT TECHNOLOGY

35 Abstracts Across NASH, PSC and Viral Hepatitis Commitment to Advancing Liver Disease Research

ACUVUE OASYS with TRANSITIONS LIGHT INTELLIGENT TECHNOLOGY

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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 

Johnson & Johnson Vision Announces Availability of ACUVUE OASYS with TRANSITIONS LIGHT INTELLIGENT TECHNOLOGY in the U.S. Baseball Superstar Bryce Harper Named Ambassador for New Contact Lenses that Seamlessly Adapt to Changing Light Conditions[1] NEWS PROVIDED BY Johnson & Johnson Vision Mar 27, 2019, 16:49 ET JACKSONVILLE, Fla., March 27, 2019 /PRNewswire/ -- Johnson & Johnson Vision

Casimersen (SRP-4045)

Seattle Genetics and Astellas reports positive data from EV-201

ACUVUE OASYS with TRANSITIONS LIGHT INTELLIGENT TECHNOLOGY

image696

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 

Sarepta Therapeutics Announces Positive Expression Results from the Casimersen (SRP-4045) Arm of the ESSENCE Study March 28, 2019 at 8:30 AM EDT CAMBRIDGE, Mass., March 28, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

INVOKANA® (canagliflozin)

Seattle Genetics and Astellas reports positive data from EV-201

Seattle Genetics and Astellas reports positive data from EV-201

image697

 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 

INVOKANA® is a prescription medicine used: along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known heart disease

Seattle Genetics and Astellas reports positive data from EV-201

Seattle Genetics and Astellas reports positive data from EV-201

Seattle Genetics and Astellas reports positive data from EV-201

image698

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 

Seattle Genetics to Host Conference Call on Positive Topline Results from Pivotal Trial of Enfortumab Vedotin March 28, 2019 07:00 AM Eastern Daylight Time BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN)

seeking biotech alpha March 2019 insight

Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF)

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

image699

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/ 

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection – In Clinical Trials, Biktarvy Demonstrated High Efficacy, Few Interactions with Other Drugs and a High Barrier to Resistance Through 48 Weeks – March 26, 2019 08:30 AM Eastern Daylight Time FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ:GILD)

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

image700

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 

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 World class team will leverage the power and accuracy of Illumina’s NovaSeq™ Sequencing System to map the interaction between human DNA and diseases through the ages March 26, 2019 02:00 AM Eastern Daylight Time SAN DIEGO--(BUSINESS WIRE)--Illumina (NASDAQ:ILMN) and the Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

Allergan plc (AGN) today announced it has completed the acquisition of Envy Medical, Inc.,

Illumina (ILMN) & Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark

Allergan plc (AGN) today announced it has completed the acquisition of Envy Medical, Inc.,

image701

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)

Allergan Acquires Envy Medical, Inc., Adding Skin Resurfacing Dermalinfusion System to Best-in-Class Medical Aesthetics Portfolio - Proprietary Skin Resurfacing Treatment for the Face and Body Reinforces Allergan's Commitment to Skin Quality - NEWS PROVIDED BY Allergan plc Mar 26, 2019, 09:00 ET DUBLIN, March 26, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN)

(etafilcon A with 0.019 mg ketotifen)

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

Allergan plc (AGN) today announced it has completed the acquisition of Envy Medical, Inc.,

image702

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 

Johnson & Johnson Vision's Investigational Antihistamine-Releasing Contact Lens Demonstrates Positive Phase 3 Results Two placebo-controlled studies published in Cornea show potential for contact lenses to correct vision and reduce occurrence of eye itch from allergies NEWS PROVIDED BY Johnson & Johnson Vision Mar 26, 2019, 08:00 ET JACKSONVILLE, Fla., March 26, 2019 /PRNewswire/ -- Johnson & Johnson Vision

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

image703

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 

Veracyte Announces New Afirma Xpression Atlas Data that Advance Genomic Understanding of Medullary Thyroid Cancer Findings Presented at ENDO 2019 Conference March 25, 2019 04:15 PM Eastern Daylight Time SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT)

oral semaglutide 3 mg, 7 mg and 14 mg

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

Afirma® Xpression Atlas suggest that the majority of newly diagnosed medullary thyroid cancers (MTC)

image704

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/ 

23 Mar 2019 19:00 CET 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 New Orleans, US, 23 March 2019

seeking biotech alpha March 2019 insight

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

image705

 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  

BIOGEN AND EISAI TO DISCONTINUE PHASE 3 ENGAGE AND EMERGE TRIALS OF ADUCANUMAB IN ALZHEIMER’S DISEASE March 21, 2019 at 7:00 AM EDT Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials CAMBRIDGE, Mass., March 21, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE

Forxiga (dapagliflozin) for patients with type 1 diabetes (T1D)

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

image706

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/ 

Forxiga approved in Europe for type-1 diabetes PUBLISHED 25 March 2019 25 March 2019 07:00 GMT Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes and the first AstraZeneca medicine ever approved for type-1 diabetes

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

anti-amyloid beta protofibril monoclonal antibody BAN2401 in patients w/early Alzheimer's disease

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

image707

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)

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis March 25, 2019 04:30 PM Eastern Daylight Time SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG

SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor

SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

image708

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 

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 -This marks the first regulatory approval globally for SKYRIZI™ (risankizumab) -SKYRIZI is a humanized immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit[1] NEWS PROVIDED BY AbbVie Mar 26, 2019, 01:00 ET NORTH CHICAGO, Ill., March 26, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV)

Bria-IMT™, with KEYTRUDA®

SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor

Bria-IMT™, with KEYTRUDA®

image709

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 

Combination Study of SV-BR-1-GM in Combination With Pembrolizumab

TriGrid® Delivery System.

SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor

Bria-IMT™, with KEYTRUDA®

image710

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. 


Ichor Medical Systems Announces Collaboration and Research License Agreement with AstraZeneca to Develop DNA-based Monoclonal Antibody Platform March 26, 2019 07:00 AM Eastern Daylight Time SAN DIEGO--(BUSINESS WIRE)--Ichor® Medical Systems, Inc.

seeking biotech alpha March 2019 insight

MAVIRET™ (glecaprevir/pibrentasvir tablets)

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

image711

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

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

CADTH Canadian Drug Expert Committee Recommendation GLECAPREVIR / PIBRENTASVIR (MAVIRET — ABBVIE CORPORATION) Indication: Chronic hepatitis C virus infection

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

image712

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 will acquire Brammer Bio for approximately $1.7 billion in cash.

DARZALEX (daratumumab), combined w/Celgene's (CELG) REVLIMID (lenalidomide)&dexamethasone

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

image713

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

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

Thermo Fisher Scientific to Acquire Brammer Bio, a Leader in Viral Vector Manufacturing Significantly expands capabilities to support high-growth gene and cell therapy market NEWS PROVIDED BY Thermo Fisher Scientific Mar 24, 2019, 20:30 ET WALTHAM, Mass. and CAMBRIDGE, Mass., March 24, 2019 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE: TMO),

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

image714

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

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

Find out moreSarepta Therapeutics to Provide Update on Duchenne Muscular Dystrophy Gene Therapy Program March 25, 2019 at 7:30 AM EDT CAMBRIDGE, Mass., March 25, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT),

Providence Cancer Institute and Galectin Therapeutics Inc. (GALT)

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

bb2121 and bb21217 for the treatment of multiple myeloma and potentially LentiGlobin™

image715

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)

March 22, 2019 Providence Cancer Institute to Present Findings on GR-MD-02 at the 2019 Keystone Symposia on Molecular and Cellular Biology NORCROSS, Ga., March 22, 2019 (GLOBE NEWSWIRE) -- Providence Cancer Institute and Galectin Therapeutics Inc. (NASDAQ: GALT),

bb2121 and bb21217 for the treatment of multiple myeloma and potentially LentiGlobin™

Phase 1 study of Sarepta’s micro-dystrophin gene therapy candidate for Duchenne muscular dystrophy

bb2121 and bb21217 for the treatment of multiple myeloma and potentially LentiGlobin™

image716

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 

bluebird bio Opens State-of-the-Art Gene and Cell Therapy Manufacturing Facility in Durham, North Carolina Gov. Cooper to cut ribbon on facility that will strengthen bluebird bio's capabilities to manufacture products for clinical development and commercial supply March 22, 2019 08:00 AM Eastern Daylight Time CAMBRIDGE, Mass. & DURHAM, N.C.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE

seeking biotech alpha March 2019 insight

Phase IIa combination study of Bria-IMT™ with KEYTRUDA® [ Merck (MRK)] in advanced breast cancer

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

Phase IIa combination study of Bria-IMT™ with KEYTRUDA® [ Merck (MRK)] in advanced breast cancer

image717

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)

BriaCell Announces $2,000,000 Non-Brokered Private Placement Offering POSTED ON MARCH 20, 2019 BY FARRAH DEAN BERKELEY, Calif., and VANCOUVER, British Columbia, March 20, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer

Novocure (NVCR) on Tumor Treating Fields at the American Association for Cancer Research (AACR)

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

Phase IIa combination study of Bria-IMT™ with KEYTRUDA® [ Merck (MRK)] in advanced breast cancer

image718

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 

Novocure Announces 48 Presentations and a Symposium Session on Tumor Treating Fields at the American Association for Cancer Research Annual Meeting 2019 A special symposium session, intended to highlight therapeutic advances, will focus on Tumor Treating Fields as a fourth modality in cancer treatment The volume of Tumor Treating Fields presentations marks a record number of abstracts for Novocure at this conference March 21, 2019 07:30 AM Eastern Daylight Time ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR)

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

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

Challenging Calcium Made Shockingly Easy Address the Challenges of Calcium Without Compromising

Viking Therapeutics, Inc. (VKTX)

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

ABIOMED (NASDAQ:ABMD) discloses a 6% stake of 1,678,843 shares in ShockWave Medical (NASDAQ:SWAV),

image719

Viking Therapeutics (VKTX) Investor Presentation - Slideshow

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

We have a pipeline of novel, first-in-class or best-in-class drug candidates for the treatment of metabolic and endocrine disorders

Sorrento Therapeutics, Inc. (SRNE)

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

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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) 

Pipeline

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

INNOVATE-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields with paclitaxel

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/

Novocure Initiates Phase 3 Pivotal Trial in Recurrent Ovarian Cancer INNOVATE-3 will test the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer Ovarian cancer is the fifth leading cause of cancer death among women March 22, 2019 07:30 AM Eastern Daylight Time ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR)

seeking biotech alpha March 2019 insight

Pfizer acquires 15% ownership stake in Vivet

oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in pill form.

Merck (MRK) to Return GDF15 Receptor Agonist Program to NGM

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics

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

Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics Pfizer and Vivet to collaborate on development of potential breakthrough therapy for Wilson disease Pfizer acquires 15% ownership stake in Vivet March 20, 2019 06:45 AM Eastern Daylight Time PARIS & NEW YORK--(BUSINESS WIRE)--Vivet Therapeutics (“Vivet”

Merck (MRK) to Return GDF15 Receptor Agonist Program to NGM

oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in pill form.

Merck (MRK) to Return GDF15 Receptor Agonist Program to NGM

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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 

Merck and NGM Bio Announce Extension of Broad, Multi-Year Strategic Collaboration to 2022 Collaboration will Continue to Focus on Discovery and Development of Novel Biologic Therapeutics Across a Range of Therapeutic Areas Merck to Return GDF15 Receptor Agonist Program to NGM March 20, 2019 06:30 AM Eastern Daylight Time KENILWORTH, N.J., and SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Merck (NYSE:MRK),

oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in pill form.

oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in pill form.

Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN) and Affibody AB today announced a partnership

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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  

20 Mar 2019 14:59 CET Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic® Bagsværd, Denmark, 20 March 2019 -

Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN) and Affibody AB today announced a partnership

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

Alexion Pharmaceuticals, Inc. (ALXN) (NASDAQ:ALXN) and Affibody AB today announced a partnership

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 Affibody Announce Partnership to Co-Develop Anti-FcRn Affibody® Molecule - Agreement provides opportunity to expand Alexion’s clinical-stage anti-FcRn portfolio with ABY-039 - - Affibody to receive $25 million upfront payment with potential for additional milestone-dependent and royalty payments, and option for U.S. co-promote - - Affibody’s technology offers potential for extended half-life compared to other anti-FcRn therapies and low volume subcutaneous administration - March 20, 2019 06:30 AM Eastern Daylight Time BOSTON & SOLNA, Sweden--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Affibody AB

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

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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 

Alexion and Zealand Pharma Announce Collaboration to Discover and Develop Peptide Therapies for Complement-Mediated Diseases - Collaboration furthers Alexion’s complement leadership with expansion into peptide therapies - - Agreement provides Alexion with exclusive worldwide licenses for one preclinical target, with option for up to three additional targets, in the complement pathway - - Zealand Pharma to receive upfront payment of $25 million and equity investment of $15 million, with potential for additional milestone-dependent and royalty payments - - Collaboration further strengthens Zealand Pharma’s position as a leading developer of next generation peptide-based therapeutics - March 20, 2019 07:00 AM Eastern Daylight Time BOSTON & COPENHAGEN, Denmark--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (NASDAQ:ZEAL)

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) & Eli Lilly (LLY)

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Zealand Pharma A/S (ZEAL) announced a collaboration

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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) 

NCCN Announces Six Quality Improvement Projects in Gastric Cancer Care Approved for Collaboration with Lilly Oncology NEWS PROVIDED BY National Comprehensive Cancer Network Mar 20, 2019, 08:45 ET PLYMOUTH MEETING, Pa. and INDIANAPOLIS, March 20, 2019 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) and Eli Lilly and Company (NYSE: LLY)

seeking biotech alpha March 2019 insight

Alinity™

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

AVYCAZ® (ceftazidime and avibactam)

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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

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 - Alinity m will allow labs to meet the growing demand for infectious disease testing by offering increased efficiency and market-leading speed and accuracy - This new technology presents one of the most significant advancements seen in the molecular diagnostics field in decades NEWS PROVIDED BY Abbott Mar 19, 2019, 08:00 ET ABBOTT PARK, Ill., March 19, 2019 /PRNewswire/ -- Abbott (NYSE: ABT)

AVYCAZ® (ceftazidime and avibactam)

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

AVYCAZ® (ceftazidime and avibactam)

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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

AVYCAZ® is indicated for the treatment of cIAI (in combination with metronidazole) in adult and pediatric patients 3 months or older, cUTI (including pyelonephritis) in adult and pediatric patients 3 months or older, and HABP/VABP in patients 18 years or older, caused by designated susceptible microorganisms. AVYCAZ (ceftazidime and avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adult and pediatric patients 3 months or older caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, and Pseudomonas aeruginosa. Complicated Urinary Tract Infections (cUTI), including Pyelonephritis AVYCAZ is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis in adult and pediatric patients 3 months or older caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis, and Pseudomonas aeruginosa.

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

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 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

KEYTRUDA® has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for KEYTRUDA®, please refer to Health Canada’s Notice of Compliance with conditions – drug products website: http://www.hc-sc.gc.ca/dhpmps/prodpharma/notices-avis/conditions/index-eng.php

HeartMate 3 left ventricular assist device (LVAD)

Data demonstrates survival benefit with the Impella RP Recover Right protocol

KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy

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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 

NEW DATA FOR ABBOTT'S HEARTMATE 3™ HIGHLIGHTS UNPARALLELED PERFORMANCE OF INDUSTRY'S LEADING HEART PUMP - New MOMENTUM 3 data show the best outcomes seen in a randomized controlled clinical trial for left ventricular assist device (LVAD) therapy - The late-breaking results were presented at the American College of Cardiology's 68th annual Scientific Session and simultaneously published in The New England Journal of Medicine NEW ORLEANS, March 17, 2019 /PRNewswire/ -- Abbott (NYSE: ABT)

Data demonstrates survival benefit with the Impella RP Recover Right protocol

Data demonstrates survival benefit with the Impella RP Recover Right protocol

Data demonstrates survival benefit with the Impella RP Recover Right protocol

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 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

Impella RP Post-Approval Study Data Presented at ACC 2019 Data demonstrates survival benefit with the Impella RP Recover Right protocol The Impella RP FDA post-market study data shows 64% survival rate for patients who meet the Recover Right criteria. March 18, 2019 07:00 AM Eastern Daylight Time NEW ORLEANS, La.--(BUSINESS WIRE)--Abiomed (NASDAQ:ABMD)

ZULRESSO™ (brexanolone) Injection

Data demonstrates survival benefit with the Impella RP Recover Right protocol

Data demonstrates survival benefit with the Impella RP Recover Right protocol

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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 

March 19, 2019 Sage Therapeutics Announces FDA Approval of ZULRESSO™ (brexanolone) Injection, the First and Only Treatment Specifically Indicated for Postpartum Depression Approval based on results from three pivotal trials showing treatment with ZULRESSO provided significant and rapid reduction of depressive symptoms within days Postpartum depression is the most common medical complication of childbirth, estimated to affect approximately 400,000 women annually in the U.S. CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 19, 2019-- Sage Therapeutics (NASDAQ: SAGE)

seeking biotech alpha March 2019 insight

FARXIGA (dapagliflozin)

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

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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 

First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in type-2 diabetes PUBLISHED 18 March 2019 Farxiga reduced major adverse cardiovascular events by 16% in patients who had a prior heart attack Farxiga reduced hospitalisation for heart failure regardless of ejection fraction status

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

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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/

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 NEWS PROVIDED BY Array BioPharma Mar 18, 2019, 08:00 ET BOULDER, Colo., March 18, 2019 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY)

(sNDA) for AVYCAZ® (ceftazidime and avibactam)

BRAFTOVI® (encorafenib) in Combination w/ MEKTOVI® (binimetinib) & ERBITUX® (cetuximab) panitumumab

(sNDA) for AVYCAZ® (ceftazidime and avibactam)

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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)

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 - NEWS PROVIDED BY Allergan plc Mar 18, 2019, 07:30 ET DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN)

Tecentriq® (atezolizumab)

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

(sNDA) for AVYCAZ® (ceftazidime and avibactam)

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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 

Basel, 19 March 2019 FDA approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC) First new initial treatment option approved by FDA for people with ES-SCLC in more than 20 years Roche (SIX: RO, ROG; OTCQX: RHHBY)

(VENCLEXTA®/VENCLYXTO®) for the investigational treatment of multiple myeloma

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

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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/

March 19, 2019 AbbVie Provides Update on VENCLEXTA®/VENCLYXTO® (venetoclax) Multiple Myeloma Program NORTH CHICAGO, Ill., March 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV),

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

saracatinib an Orphan Drug for the treatment of idiopathic pulmonary fibrosis (IPF).

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US FDA grants saracatinib Orphan Drug Designation for idiopathic pulmonary fibrosis  

18 March 2019 07:00 GMT

 AstraZeneca PLC (AZN) 

 

seeking biotech alpha March 2019 insight

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

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 

NEW LATE-BREAKING ANALYSES FROM LANDMARK COAPT™ TRIAL SHOW BENEFITS OF ABBOTT'S MITRACLIP™ DEVICE - New data presented and simultaneously published in the Journal of the American College of Cardiology show treatment with MitraClip resulted in significant and sustained long-term quality-of-life improvements compared to medical therapy - Data from a sub-analysis of imaging data provides further clarity regarding which patients benefit most from treatment with MitraClip - On Thursday, MitraClip received FDA approval for new, expanded indication to treat heart failure patients with secondary mitral regurgitation NEW ORLEANS, March 17, 2019 /PRNewswire/ -- Abbott (NYSE: ABT)

LUMINIZE™ Radiofrequency (RF) Balloon Catheter

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

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 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 

Late-breaking Clinical Trial Highlights Positive Safety and Efficacy Data for the LUMINIZE™ RF Balloon Catheter New data showcasing performance of recently acquired RF balloon-based, single-shot ablation technology LISBON, Portugal and MARLBOROUGH, Mass., March 17, 2019 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX)

Rubraca® (rucaparib)

MitraClip™ for heart failure patients w/ clinically significant secondary or mitral regurgitation

Rubraca® (rucaparib)

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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/

Clovis Oncology to Highlight Rubraca® (rucaparib) Data from Post-Hoc ARIEL3 Analyses at SGO 2019 Congress Exploratory analyses of ARIEL3 Rubraca data in recurrent ovarian cancer presented in oral plenary and poster sessions Maintenance treatment with Rubraca improved median progression-free survival (PFS) and reduced the risk of progression vs placebo regardless of age subgroup Maintenance treatment with Rubraca significantly improved PFS and reduced the risk of progression vs placebo regardless of whether tumors had deleterious germline BRCA mutations Safety profile of Rubraca was consistent with the overall safety population previously reported March 16, 2019 12:45 PM Eastern Daylight Time BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS)

Novocure (NVCR)

Stryker acquires OrthoSpace, Ltd.

Rubraca® (rucaparib)

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 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) 

The science of Tumor Treating Fields has the potential to extend beyond glioblastoma. Tumor Treating Fields has shown a consistent anti-mitotic effect in our preclinical and clinical research over the last 18 years.

Eliquis® (apixaban)

Stryker acquires OrthoSpace, Ltd.

Stryker acquires OrthoSpace, Ltd.

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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/

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 AUGUSTUS is the largest trial in this high-risk patient population requiring both anticoagulant and antiplatelet therapies March 17, 2019 11:45 AM Eastern Daylight Time PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--The Bristol-Myers Squibb-Pfizer

Stryker acquires OrthoSpace, Ltd.

Stryker acquires OrthoSpace, Ltd.

Stryker acquires OrthoSpace, Ltd.

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.

seeking biotech alpha March 2019 insight

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

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Abbott Receives FDA Approval for Expanded Indication for MitraClip™ Device

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

ABBOTT RECEIVES FDA APPROVAL FOR EXPANDED INDICATION FOR MITRACLIP™ DEVICE - The world's first minimally invasive mitral valve repair device now approved to help difficult-to-treat heart failure patients with clinically significant secondary mitral regurgitation - Approval is based on groundbreaking pivotal data from the COAPT™ Trial - New indication significantly expands number of people with mitral regurgitation that can be treated with the MitraClip device ABBOTT PARK, Ill., March 14, 2019 /PRNewswire/ -- Abbott (NYSE: ABT)

Repatha® (evolocumab)

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

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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 

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 VESALIUS-CV is the Latest Study in Amgen's PROFICIO Clinical Program Investigating the Impact of Repatha on CVD in Multiple Patient Populations Phase 3 Study Will Enroll High-Risk Patients who Have Significant Atherosclerotic Disease or Diabetes and are at High Risk for a First Cardiovascular Event THOUSAND OAKS, Calif., March 15, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

MitraClip™ device used to repair a leaky mitral valve without open-heart surgery.

OPSUMIT® (macitentan)

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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)

March 15, 2019 at 4:01 PM EDT Back PRALUENT® (ALIROCUMAB) NOW APPROVED IN EUROPEAN UNION TO REDUCE THE RISK OF CARDIOVASCULAR EVENTS IN PATIENTS WITH ESTABLISHED CARDIOVASCULAR DISEASE TARRYTOWN, N.Y. and PARIS, March 15, 2019 /PRNewswire/ -- Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome such as a heart attack Praluent is the only EU-approved PCSK9 inhibitor with cardiovascular outcomes data that showed an association with reduced death from any cause Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi

OPSUMIT® (macitentan)

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

OPSUMIT® (macitentan)

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 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?

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) Actelion Presents REPAIR Study Interim Analysis at the American College of Cardiology's 68th Annual Scientific Session (PRNewsfoto/Actelion Pharmaceuticals US, In) NEWS PROVIDED BY Actelion Pharmaceuticals US, Inc. Mar 15, 2019, 09:00 ET SOUTH SAN FRANCISCO, Calif. and ALLSCHWIL, Switzerland, March 15, 2019 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

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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

U.S. FDA Clears da Vinci SP for Certain Transoral Otolaryngology Procedures March 15, 2019 at 1:36 PM EDT Intuitive’s single-port system cleared for radical tonsillectomy and tongue base resection SUNNYVALE, Calif., March 15, 2019 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq:ISRG)

MabThera (rituximab) for a rare autoimmune disease

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

da Vinci SP® surgical system for use in certain transoral otolaryngology procedures in adults.

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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)

SWITZERLAND MARKET REPORTMARCH 15, 2019 / 2:04 AM / UPDATED 19 HOURS AGO BRIEF-European Commission Approves Roche's Mabthera (Rituximab) For Rare Autoimmune Disease 1 MIN READ March 15 (Reuters) - Roche Holding AG: * EUROPEAN COMMISSION APPROVES ROCHE’S MABTHERA (RITUXIMAB) FOR A RARE AUTOIMMUNE DISEASE Source text for Eikon: Further company coverage: (Reporting by Riham Alkousaa)

seeking biotech alpha March 2019 insight

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

image747

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) 

There’s an alternative to warfarin for people who need one. It’s called WATCHMAN. The only FDA-approved implant proven to reduce stroke risk in people with atrial fibrillation not caused by a heart valve problem (also referred to as non-valvular AFib)

Praluent® (alirocumab)

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

image748

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/

Regeneron and Sanofi to Present New Praluent® (alirocumab) Data at ACC.19 NEWS PROVIDED BY Regeneron Pharmaceuticals, Inc. Mar 13, 2019, 07:00 ET TARRYTOWN, N.Y. and BRIDGEWATER, N.J., March 13, 2019 /PRNewswire/ -- Sub-analyses from ODYSSEY OUTCOMES trial, including featured clinical research, provide new Praluent insights

Ampligen

WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC)

Hemlibra® (emicizumab)

image749

 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  

Hemispherx Biopharma Announces Significant Progress in its Ampligen Pancreatic Cancer Program and Multiple Ampligen+Checkpoint Blockade Immuno-Oncology Programs Hemispherx Provides Quarterly Summary of Rapidly Advancing Oncology Clinical Programs OCALA, Fla., March 13, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma Inc. (NYSE American: HEB) ("Hemispherx" or the "Company"), an immuno-pharma R&D company focused on unmet medical needs in immunology

Hemlibra® (emicizumab)

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

Hemlibra® (emicizumab)

image750

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 

Dec 21, 2018 Chugai’s HEMLIBRA® Subcutaneous Injection Receives Approval for Hemophilia A without Inhibitors and Extension of Dosing Interval -- HEMLIBRA is now available for Hemophilia A, regardless of inhibitor status -- TOKYO, December 21, 2018 -- Chugai Pharmaceutical Co., Ltd

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

image751

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 

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) European Approval Based on KEYNOTE-407 Study Results Demonstrating Significant Improvement in Overall Survival with KEYTRUDA in Combination with Chemotherapy Compared to Chemotherapy Alone KEYTRUDA is First Anti-PD-1 Therapy Approved in Combination with Chemotherapy in Europe for Adults with Metastatic Squamous NSCLC Regardless of PD-L1 Expression Thursday, March 14, 2019 6:45 am EDT KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK),

Venovo™ venous stent

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

image752

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)

BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease Venovo™ Venous Stent proven safe and effective in iliac and femoral veins NEWS PROVIDED BY BD (Becton, Dickinson and Company) Mar 14, 2019, 06:59 ET FRANKLIN LAKES, N.J., March 14, 2019 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX)

seeking biotech alpha March 2019 insight

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

image753

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  

Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot program Raritan, NJ, March 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

TECENTRIQ® in Combination with ABRAXANE®

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

image754

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/

Celgene Provides Update on ABRAXANE® Combination Therapy in the Treatment of Metastatic Triple-Negative Breast Cancer and Pancreatic Cancer March 12, 2019 ECENTRIQ ® in Combination with ABRAXANE ® receives accelerated approval for people with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer Top-line results announced from the international Phase 3 study evaluating adjuvant therapy with ABRAXANE in combination with gemcitabine vs. gemcitabine alone for patients with surgically resected pancreatic cancer SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced two updates for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the treatment of metastatic triple-negative breast cancer and early stage pancreatic cancer.

Diovan (valsartan)

Darzalex (daratumumab), combined with Celgene's (CELG) Revlimid (lenalidomide) & dexamethasone

Editas Medicine, Inc. (EDIT)

image755

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  

ABOUT DIOVAN & DIOVAN HCT Diovan is a prescription blood pressure medicine called an angiotensin receptor blocker (ARB). It relaxes and widens your blood vessels, allowing blood to flow more easily. This helps reduce your blood pressure and the stress on your heart. Diovan is a prescription medicine for high blood pressure called an angiotensin receptor blocker, or ARB. Diovan lowers high blood pressure by blocking a chemical called angiotensin II.

Editas Medicine, Inc. (EDIT)

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

Editas Medicine, Inc. (EDIT)

image756

Editas Medicine (EDIT) Investor Presentation - Slideshow

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

Editas Medicine is building the leading genome editing company dedicated to treating patients with genetically defined diseases. Furthermore, a new technology known as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) has the potential to achieve accurate, directed changes in DNA and fulfill the promise that started with the sequencing of the human genome – the potential to treat diseases at their source, at the DNA level.

Station B platform

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

image757

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/

Station B is part of this broader effort, with a focus on developing an integrated platform that enables selected partners to improve productivity within their own organisations, in line with Microsoft’s core mission. The Station B project builds on over a decade of research at Microsoft on understanding and programming information processing in biological systems, in collaboration with several leading universities.

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

Regeneron Pharmaceuticals, Inc. (REGN) and Society for Science & the Public

image758

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/

Teen Scientists Win $1.8 Million at Regeneron Science Talent Search 2019 with Innovative Ideas on Exoplanets, HIV and a Classic Math Problem NEWS PROVIDED BY Regeneron Pharmaceuticals, Inc. Mar 12, 2019, 21:56 ET TARRYTOWN, N.Y. and WASHINGTON, March 12, 2019 /PRNewswire/ --

seeking biotech alpha March 2019 insight

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

image759

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)

U.S. FDA APPROVES PFIZER’S ONCOLOGY BIOSIMILAR TRAZIMERA™ (TRASTUZUMAB-QYYP), A BIOSIMILAR TO HERCEPTIN®1 Monday, March 11, 2019 - 7:37pm EDT Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2

CYRAMZA® (ramucirumab)

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

image760

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 

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 03/12/2019 Global, randomized, placebo-controlled study confirms CYRAMZA, in combination with erlotinib, significantly delayed disease progression in previously untreated patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations Global regulatory submissions to be initiated this year Second positive Phase 3 study of CYRAMZA in metastatic non-small cell lung cancer INDIANAPOLIS, March 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)

TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab)

NBI-74788, a proprietary corticotropin-releasing factor type 1 (CRF1) receptor antagonist

image761

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 

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 -A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis- -First medicine in Australia to treat the underlying cause of cystic fibrosis in patients who have certain mutations that result in residual CFTR function- BOSTON--(BUSINESS WIRE)--Mar. 12, 2019

NBI-74788, a proprietary corticotropin-releasing factor type 1 (CRF1) receptor antagonist

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

NBI-74788, a proprietary corticotropin-releasing factor type 1 (CRF1) receptor antagonist

image762

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

Neurocrine Biosciences Reports Positive Interim Results from Phase II Study of NBI-74788 in Adults with Classic Congenital Adrenal Hyperplasia - NBI-74788 Achieved Study Goals and Demonstrated Reductions in Key Disease Biomarkers Exceeding Predetermined Threshold for Proof-of-Concept - Based on Interim Results, Company Plans to Meet with FDA to Discuss the Registration Program in Adult and Pediatric Patients with Congenital Adrenal Hyperplasia SAN DIEGO, March 12, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX)

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

image763

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/

FDA approves Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents * Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis * In a Phase 3 trial, Dupixent significantly reduced the extent and severity of disease and itching, and helped adolescents achieve clearer skin CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/

Station B

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

Dupixent® (dupilumab) for adolescent patients 12 to 17 with moderate-to-severe atopic dermatitis

image764

 

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.

Station B - Building a platform for programming biology The Station B platform is being developed at Microsoft Research in Cambridge, UK, which houses Microsoft’s first molecular biology laboratory. The platform aims to improve all phases of the Design-Build-Test-Learn workflow typically used for programming biological systems:

seeking biotech alpha March 2019 insight

Bristol-Myers Squibb C... (BMY)

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

image765

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

Bristol-Myers Squibb Issues Statement in Response to Starboard’s Letter CATEGORY: CORPORATE/FINANCIAL NEWS THURSDAY, FEBRUARY 28, 2019 11:59 AM EST NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today issued the following statement in response to a letter from Starboard Value (“Starboard”):

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

image766

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/

Friday, Mar 8, 2019 FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer This Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer Triple-negative breast cancer is an aggressive disease, with high unmet medical need South San Francisco, CA -- March 8, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

Medtronic plc (MDT)

Tecentriq® (atezolizumab) plus chemo (Abraxane® [paclitaxel protein-bound particles for injectable

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

image767

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)

Medtronic Announces Cash Dividend for Fourth Quarter of Fiscal Year 2019 Medtronic plc Board Authorizes $6 Billion for Share Repurchases DUBLIN - March 8, 2018 - The board of directors of Medtronic plc (NYSE:MDT) today approved the fiscal year 2019 fourth quarter cash dividend of $0.50 per ordinary share, representing a 9 percent increase over the prior year.

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

image768

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)

Celgene Submits Application to EMA for Ozanimod for the Treatment of Relapsing-Remitting Multiple Sclerosis March 11, 2019 New Drug Application submission to U.S. FDA on track for end of March SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

ubrogepant for the acute treatment of migraine in adults.

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

ubrogepant for the acute treatment of migraine in adults.

image769

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)

Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine - Ubrogepant Seeks to be the First Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for the Acute Treatment of Migraine - - Allergan Continues to Expand Its Leading Migraine Portfolio Across the Spectrum of the Disease from Episodic to Chronic - NEWS PROVIDED BY Allergan plc Mar 11, 2019, 07:30 ET DUBLIN, March 11, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN)

Seres Therapeutics (MCRB) & AstraZeneca (AZN)

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator

ubrogepant for the acute treatment of migraine in adults.

image770

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  

Seres Therapeutics Announces Microbiome Immuno-Oncology Focused Collaboration with AstraZeneca - Collaboration focused on further elucidating the potential of microbiome therapeutics to augment immuno-oncology treatment for cancer – - Seres to receive $20 million and financial support for research activities – - Company to further discuss collaboration during webcast Cowen healthcare conference presentation scheduled for 11:20 a.m. ET today – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 11, 2019-- Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced a three-year research collaboration with AstraZeneca. The collaboration will focus on advancing mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including potential synergy with AstraZeneca compounds.

seeking biotech alpha March 2019 insight

GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function

image771

 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)

March 07, 2019 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 FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 7, 2019-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced findings from two studies that support the further development of GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function, for potential future use as part of long-acting HIV combination therapy.

Dupixent® (dupilumab)

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function

image772

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

March 8, 2019 at 12:59 AM EST Back FDA TO UNDERTAKE PRIORITY REVIEW OF DUPIXENT® (DUPILUMAB) FOR ADULTS WITH INADEQUATELY CONTROLLED SEVERE CHRONIC RHINOSINUSITIS WITH NASAL POLYPS TARRYTOWN, N.Y. and PARIS, March 8, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

image773

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

Basel, 08 March 2019 European Commission approves Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer Approval based on significant survival benefit of Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) in people with metastatic non-squamous non-small cell lung cancer (NSCLC) compared with Avastin plus chemotherapy New treatment option for EGFR mutant or ALK-positive non-small cell lung cancer patients after appropriate targeted therapy Roche (SIX: RO, ROG; OTCQX: RHHBY)

zinc finger nuclease (ZFN) platform technology

darolutamide, a non-steroidal androgen receptor antagonist

Tecentriq (atezolizumab), combined with Avastin (bevacizumab) and chemo paclitaxel and carboplatin

image774

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 

Sangamo Therapeutics Announces Publication Of Data Demonstrating New Zinc Finger Nuclease Architectures Enabling High-Precision Genome Editing March 8, 2019 at 5:00 AM EST Download PDF -- Data published in Nature Communications show new architectures increase targeting capabilities by 64-fold -- Highly precise editing demonstrated at multiple genomic loci BRISBANE, Calif., March 8, 2019 /PRNewswire/ -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO

darolutamide, a non-steroidal androgen receptor antagonist

darolutamide, a non-steroidal androgen receptor antagonist

darolutamide, a non-steroidal androgen receptor antagonist

image775

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 

3/8/2019 Darolutamide submitted for European marketing authorization Orion Corporation Press Release Communications 8 March 2019 at 8:30 a.m. EET Darolutamide submitted for European marketing authorization Orion Corporation and Bayer today announced that a marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Regulatory submission is based on positive data from Phase III study ARAMIS. Third submission for darolutamide in two weeks underscores Orion's and Bayer's commitment to fill an unmet need for men with nmCRPC worldwide.

SOLIRIS® (Eculizumab)

darolutamide, a non-steroidal androgen receptor antagonist

darolutamide, a non-steroidal androgen receptor antagonist

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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 

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 -- New data suggest positive impact on clinical burden and sustained long-term clinical benefit for adult patients with anti-acetylcholine receptor (AChR) antibody-positive refractory generalized myasthenia gravis (gMG) -- March 08, 2019 09:05 AM Eastern Standard Time BOSTON--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)

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