seeking biotech alpha April 2019 insight

Phase I/IIa clinical trial of Bria-IMT™, its lead candidate, & combination pembrolizumab [KEYTRUDA®

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BriaCell Announces Publication at American Society of Clinical Oncology (ASCO) Meeting and Presentation at Precision Breast Cancer Summit in Boston

Tue April 23, 2019 6:30 AM|GlobeNewswire|About: BCTXF, MRK

BERKELEY, Calif. and VANCOUVER, British Columbia, April 23, 2019 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (BCTXF) ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF)

BriaCell Announces Publication at American Society of Clinical Oncology (ASCO) Meeting and Presentation at Precision Breast Cancer Summit in Boston POSTED ON APRIL 23, 2019 BY FARRAH DEAN BERKELEY, Calif., and VANCOUVER, British Columbia, April 23, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF)

VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients

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Basel, 23 April 2019

Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy

  • Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2
  • The VENTANA HER2 Dual ISH DNA Probe Cocktail assay3 aids in identifying breast and gastric cancer patients eligible for the targeted Roche drug Herceptin (trastuzumab), providing fast results with widely available laboratory instruments.

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin can be used in several different ways:

SPINRAZA™(nusinersen)

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Patients living with Spinal Muscular Atrophy (SMA) in the province of Saskatchewan gain access to SPINRAZA™ (nusinersen)

Mon April 22, 2019 7:00 AM|Canada Newswire|About: BIIB 

SPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

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

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AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

Tue April 23, 2019 6:19 PM|PR Newswire|About: ABBV 

NORTH CHICAGO, Ill., April 23, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV) April 23, 2019 AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

Stryker Corporation (SYK)

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Stryker reports first quarter 2019 operating results

Tue April 23, 2019 4:05 PM|GlobeNewswire|About: SYK

Kalamazoo, Michigan, April 23, 2019 (GLOBE NEWSWIRE) -- Stryker (NYSE:SYK) reported operating results for the first quarter of 2019:

First Quarter Highlights

  • Reported net sales increased 8.5% to $3.5 billion
  • Organic net sales increased 7.3%
  • Reported operating income margin of 15.0%

Stryker reports first quarter 2019 operating results 04/23/2019 Kalamazoo, Michigan, April 23, 2019 (GLOBE NEWSWIRE) -- Stryker (NYSE:SYK) reported operating results for the first quarter of 2019:

seeking biotech alpha April 2019 insight

Taltz® (ixekizumab)

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Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis

04/22/2019Download PDF

INDIANAPOLIS, April 22, 2019 /PRNewswire/ -- Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 study 

Taltz is a prescription medicine used to treat adults with active psoriatic arthritis. Taltz is also a treatment for adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

VenaSeal(TM) Closure System in treating patients with chronic venous disease.

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Medtronic VenaSeal(TM) Closure System Demonstrates Durable and Consistent Outcomes at Five Years in Patients with Chronic Venous Disease

Wed April 17, 2019 5:00 AM|InPublic US|About: MDT 

Medtronic VenaSeal(TM) Closure System Demonstrates Durable and Consistent Outcomes at Five Years in Patients with Chronic Venous Disease (GLOBE NEWSWIRE via COMTEX) --DUBLIN and LONDON - April 17, 2019 - Medtronic plc (NYSE:MDT)

Zolgensma® (onasemnogene abeparvovec-xioi; AVXS-101)[1] in spinal muscular atrophy (SMA) Type 1

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AveXis data reinforce effectiveness of Zolgensma® in treating spinal muscular atrophy (SMA) Type 1 

 Basel, April 16, 2019 - AveXis, a Novartis company, 


 Zolgensma, previously knowns as AVXS-101, is the proprietary gene therapy candidate from AveXis designed to treat spinal muscular atrophy (SMA). 

Zolgensma, previously knowns as AVXS-101, is the proprietary gene therapy candidate from AveXis designed to treat spinal muscular atrophy (SMA).

SKYRIZI™(risankizumab)

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Health Canada Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

Thu April 18, 2019 10:04 AM|Canada Newswire|About: ABBV 

Welcome to the AbbVie Care Program

Amgen Biotech Experience (ABE) program in Tampa, Florida

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Amgen Foundation Launches Amgen Biotech Experience In Tampa, Florida

Wed April 17, 2019 4:00 PM|PR Newswire|About: AMGNPR Newswire

TAMPA, Fla., April 17, 2019 /PRNewswire/ -- The Amgen (AMGN) Foundation, together with the University of South Florida (USF)

Amgen Foundation Launches Amgen Biotech Experience In Tampa, Florida Long-Established Science Education Program to Give Local Secondary School Students Hands-On Biotechnology Lab Experience NEWS PROVIDED BY Amgen Apr 17, 2019, 16:00 ET TAMPA, Fla., April 17, 2019 /PRNewswire/ -- The Amgen Foundation, together with the University of South Florida (USF),

seeking biotech alpha April 2019 insight

guselkumab (Tremfya(R))

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 MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Familial Adenomatous Polyposis

Mon April 15, 2019 4:25 PM|Accesswire|About: JNJ, MOR

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / April 15, 2019 / MorphoSys AG (MPSYF) (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR)

MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Familial Adenomatous Polyposis You are here HOMEMEDIA AND INVESTORSINVESTOR & MEDIA INFORMATIONMORPHOSYS ANNOUNCES THAT ITS LICENSEE JANSSEN... April 15, 2019 / 10:01 pm, CEST Planegg/Munich, Germany, April 15, 2019 MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Familial Adenomatous Polyposis

brolucizumab (RTH258) for patients with wet AMD

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 Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD

Apr 15, 2019

  • By 2020, over 1.5 million people in the US are likely to have wet AMD, the leading cause of blindness in industrialized countries
     
  • Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab
     
  • Novartis used a priority review voucher to expedite review of brolucizumab in the US and, if approved by FDA, anticipates launching by the end of 2019

Basel, April 15, 2019

timing of treatment and serum creatinine (SCr) at treatment start

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Data on Impact of Revised Consensus Recommendations on Time to Treatment and Serum Creatinine (SCr) at Treatment Start for Patients with Hepatorenal Syndrome Type 1 (HRS-1) Presented at the 2019 International Liver Congress™ (EASL)

Mon April 15, 2019 6:45 AM|PR Newswire|About: MNKPR Newswire

STAINES-UPON-THAMES, United Kingdom, April 15, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

NEWS PROVIDED BY Mallinckrodt plc Apr 15, 2019, 06:45 ET SHARE THIS ARTICLE STAINES-UPON-THAMES, United Kingdom, April 15, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK) Data on Impact of Revised Consensus Recommendations on Time to Treatment and Serum Creatinine (SCr) at Treatment Start for Patients with Hepatorenal Syndrome Type 1 (HRS-1) Presented at the 2019 International Liver Congress™ (EASL)

discover and develop therapies for patients with nonalcoholic steatohepatitis (NASH)

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Gilead and insitro Announce Strategic Collaboration to Discover and Develop Novel Therapies for Nonalcoholic Steatohepatitis

Tue April 16, 2019 7:00 AM|Business Wire|About: GILD

FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Gilead Sciences Inc. (GILD) and insitro

Gilead and insitro Announce Strategic Collaboration to Discover and Develop Novel Therapies for Nonalcoholic Steatohepatitis April 16, 2019 07:00 AM Eastern Daylight Time FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Gilead Sciences Inc. (Nasdaq: GILD)

Fast Track Designation for CTX001

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CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Beta Thalassemia

Tue April 16, 2019 7:00 AM|GlobeNewswire|About: CRSP, VRTX

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, April 16, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals Incorporated (VRTX)


  www.crisprtx.com 


  www.vrtx.com 

CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Beta Thalassemia ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, April 16, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)

seeking biotech alpha April 2019 insight

INVOKANA® (canagliflozin)

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 INVOKANA® (canagliflozin) Significantly Reduces the Risk of Renal Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in the Landmark   Melbourne, Australia, April 14, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson  
Phase 3 CREDENCE Study 

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

FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for w/ BALVERSA™ (erdafitinib)

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QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer

Fri April 12, 2019 3:23 PM|Business Wire|About: QGEN

Novel therascreen® FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for treatment with BALVERSA™ (erdafitinib), developed by Janssen

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN N.V. (QGEN

QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer Novel therascreen® FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for treatment with BALVERSA™ (erdafitinib), developed by Janssen April 12, 2019 03:23 PM Eastern Daylight Time GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE:QGEN;

Balversa (erdafitinib)

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BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

  • BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval
  • Simultaneous approval of companion diagnostic intended to identify a subset of patients most likely to benefit from BALVERSA, offering a personalized treatment approach

Horsham, PA, April, 12 – The Janssen Pharmaceutical Companies of Johnson & Johnson 

seeking biotech alpha April 2019 insight

Vemlidy® (tenofovir alafenamide 25mg, TAF)

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Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019

Thu April 11, 2019 9:18 AM|Business Wire|About: GILD

– Data Demonstrate Role of Gilead HCV Medicines in Difficult–to-Treat Patient Populations and in Real-World Settings –

– Latest HBV Data Reinforce Role of Treatment with Vemlidy and Demonstrate Progress in Cure Research –

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


 https://www.vemlidy.com/ 


 https://www.epclusa.com/ 


April 11, 2019 Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 – Data Demonstrate Role of Gilead HCV Medicines in Difficult–to-Treat Patient Populations and in Real-World Settings – – Latest HBV Data Reinforce Role of Treatment with Vemlidy and Demonstrate Progress in Cure Research – FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 11, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD)

MAVIRETTM (glecaprevir/pibrentasvir tablets)

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AbbVie's MAVIRET™ now reimbursed in Quebec

Thu April 11, 2019 9:00 AM|Canada Newswire|About: ABBV

  • MAVIRET is now listed under the "Régie de l'assurance maladie du Québec" List of Medications.
  • MAVIRET is the first and only 8-week, pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to treatment.*1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease (CKD).

MONTREAL, April 11, 2019 /CNW/ - AbbVie (ABBV)

MAVIRET treats people with chronic (long-lasting) hepatitis C in adults. Hepatitis C is caused by an infection with the hepatitis C virus (HCV). ● There are 2 medicines in MAVIRET. They are called glecaprevir and pibrentasvir

Testosterone Gel 1.62% CIII

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Teva Announces Launch of a Generic Version of AndroGel® (testosterone gel) 1.62% CIII in the United States

Thu April 11, 2019 10:00 AM|Business Wire|About: TEVA

JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (TEVVF) (NYSE and TASE: TEVA) 

Teva Announces Launch of a Generic Version of AndroGel® (testosterone gel) 1.62% CIII in the United States JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of a generic version of AndroGel ®i (testosterone gel) 1.62% CIII in the U.S.

SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg

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 Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks

High Proportion of Patients Achieve Undetectable Viral Loads after Rapidly Starting SYMTUZA®1

Miami, FL., April 11, 2019

SYMTUZA® is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who: have not received anti-HIV-1 medicines in the past, or when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

LibtayoTM (cemiplimab) for treatment of adult patients w/ metastatic/ locally advanced (CSCC)

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 Health Canada issues Notice of Compliance with Conditions (NOC/c) for LibtayoTM (cemiplimab), the first and only biologic for the treatment of advanced cutaneous squamous cell carcinoma (CSCC)

Thu April 11, 2019 2:43 PM|Canada Newswire|About: SNY

Source: Sanofi (SNY) (EURONEXT: SAN) (NYSE: SNY)

* CSCC is the second most common skin cancer in Canadai

TORONTO, April 11, 2019 /CNW Telbec/ - Sanofi Genzyme


 https://www.melanomanetwork.ca/skincancer/ 

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

seeking biotech alpha April 2019 insight

Phase 2 Study of VK2809 in Patients w/ Non-Alcoholic Fatty Liver Disease & Elevated LDL-Cholesterol

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 Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019Patients Receiving 5 mg Daily Doses of VK2809 Demonstrated Statistically Significant Median Reduction in Liver Fat Content of 53.8%88% of Patients Receiving VK2809 Experienced ≥ 30% Reduction in Liver Fat Content at 12 Weeks, Including all Patients Receiving 5 mg Daily DosesVK2809 was Safe and Well Tolerated at all Doses Studied; No SAEs Reported in Any Cohort

SAN DIEGO, April 11, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX)

Viking’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH

myChoice® HRD CDx test.

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Myriad Genetics Submits First Module of the Premarket Approval Application to FDA for the myChoice® HRD CDx Test

Tue April 9, 2019 7:05 AM|GlobeNewswire|About: MYGNGlobeNewswire

SALT LAKE CITY, April 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN)


 myChoice® HRD CDx 

Myriad Genetics Submits First Module of the Premarket Approval Application to FDA for the myChoice® HRD CDx Test myChoice HRD Is Intended to Identify Patients with Ovarian, Fallopian or Primary Peritoneal Cancer Who May Benefit from Treatment with Zejula SALT LAKE CITY, April 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN)

Galectin Therapeutics, Inc. (GALT)

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Galectin Therapeutics (GALT) Presents At H.C. Wainwright & Co. Annual Global Life Sciences Conference - Slideshow

Apr. 9, 2019 2:19 PM ET  | About: Galectin Therapeutics, Inc. (GALT) 

OUR PIPELINE

Positive Data from REGENERATE, the First Successful Phase 3 Study in NASH

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 Apr 11, 2019

Intercept Reports Additional Positive Data from REGENERATE, the First Successful Phase 3 Study in NASH

 

OCA significantly improved fibrosis in patients with liver fibrosis due to NASH and demonstrated consistent efficacy across multiple histologic and biochemical parameters

REGENERATE data to be presented during the Opening Ceremony of EASL

NEW YORK, April 11, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)

PIPELINE Novel compounds being developed for liver diseases

seeking biotech alpha April 2019 insight

CAB CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor

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BioAtla and BeiGene Form Worldwide Collaboration to Develop and Commercialize Novel Conditionally Active Biologic CTLA-4 Therapy

Tue April 9, 2019 6:05 AM|GlobeNewswire|About: BGNEGlobeNewswire

SAN DIEGO and BEIJING, China and CAMBRIDGE, Mass., April 09, 2019 (GLOBE NEWSWIRE) -- BioAtla ®, LLC


 https://www.bioatla.com/news/ 

BioAtla and BeiGene Form Worldwide Collaboration to Develop and Commercialize Novel Conditionally Active Biologic CTLA-4 Therapy Plan to pursue development as a monotherapy and in combination with BeiGene’s investigational anti-PD-1 antibody, tislelizumab SAN DIEGO and BEIJING, China and CAMBRIDGE, Mass., April 09, 2019 (GLOBE NEWSWIRE) -- BioAtla ®, LLC,

LYNPARZA® (olaparib)

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 LYNPARZA® (olaparib) Approved in EU for the Treatment of Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

Wed April 10, 2019 6:45 AM|Business Wire|About: MRK

AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 42 Percent Versus Chemotherapy in Phase 3 OlympiAD Trial

First PARP Inhibitor Approved in the EU for This Indication and Third EU Approval for LYNPARZA

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


 https://www.lynparzahcp.com/recurrent-ovarian-cancer/olaparib-efficacy/first-line-efficacy.html 

Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer PUBLISHED 10 April 2019 10 April 2019 07:00 BST AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 42% vs. chemotherapy in Phase III OlympiAD trial First PARP inhibitor approved in the EU for patients with this difficult-to-treat disease and third EU approval for Lynparza AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada

Controlling Parkinson’s Motor Symptoms With Resiniferatoxin (RTX) Intrathecal Administration

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 Sorrento Therapeutics Announces Discovery of a Potential Non-Dopaminergic Approach to Controlling Parkinson’s Motor Symptoms With Resiniferatoxin (RTX) Intrathecal Administration

Wed April 10, 2019 9:00 AM|GlobeNewswire|About: SRNE

SAN DIEGO, April 10, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE)

Sorrento Therapeutics Announces Discovery of a Potential Non-Dopaminergic Approach to Controlling Parkinson’s Motor Symptoms With Resiniferatoxin (RTX) Intrathecal Administration Apr 10, 2019 at 9:00 AM EDT PDF Version SAN DIEGO, April 10, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento")

EVENITY™ (romosozumab-aqqg)

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FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

  • Tue April 9, 2019 3:57 PM|PR Newswire|About: AMGN, UCBJY
  • EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2)
  • EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2)

PR Newswire

THOUSAND OAKS, Calif. and BRUSSELS, April 9, 2019 /PRNewswire/ -- Amgen (AMGN) and UCB (Euronext Brussels: UCB THOUSAND OAKS, Calif. and BRUSSELS, April 9, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB)  

NEWS PROVIDED BY Amgen Apr 09, 2019, 15:57 ET FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture One in Two Women in the United States Will Suffer a Fracture in Her Lifetime Due to Osteoporosis(1) EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2) EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2)

Geron Corporation (GERN)

image41

Geron (GERN) Presents At 18th Annual Needham Healthcare Conference - Slideshow

Apr. 9, 2019 3:49 PM ET|8 comments  | About: Geron Corporation (GERN) 

Insulins Valyou Savings Program

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Sanofi provides unprecedented access to its insulins for one set monthly price

  • Wed April 10, 2019 5:00 AM|PR Newswire|About: SNY
  • * Further expansion of the Insulins Valyou Savings Program - now people can pay $99 for up to 10 boxes of pens and/or 10 mL vials per month

PR Newswire

BRIDGEWATER, N.J., April 10, 2019 /PRNewswire/ -- Starting in June, Sanofi (SNY


 Insulins Valyou Savings Program  

BRIDGEWATER, N.J., April 10, 2019 /PRNewswire/ NEWS PROVIDED BY Sanofi Apr 10, 2019, 05:00 ET Sanofi provides unprecedented access to its insulins for one set monthly price * Sanofi continues its commitment to helping reduce cost burden for people living with diabetes with first-ever insulin savings program * Further expansion of the Insulins Valyou Savings Program - now people can pay $99 for up to 10 boxes of pens and/or 10 mL vials per month

seeking biotech alpha April 2019 insight

Systemic Gene Transfer w/ AAVrh74.MHCK7.SGCB Increased β-sarcoglycan Expression in Patients

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Sarepta Therapeutics’ Gene Therapy Limb-Girdle Muscular Dystrophy Type 2E Clinical Data has been Accepted for a Late-breaking Oral Presentation at the 2019 MDA Clinical and Scientific Conference

Mon April 8, 2019 8:30 AM|GlobeNewswire|About: SRPTGlobeNewswire

CAMBRIDGE, Mass., April 08, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)


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

Sarepta Therapeutics’ Gene Therapy Limb-Girdle Muscular Dystrophy Type 2E Clinical Data has been Accepted for a Late-breaking Oral Presentation at the 2019 MDA Clinical and Scientific Conference April 8, 2019 at 8:30 AM EDT -Six additional poster presentations highlighting data from Sarepta’s RNA and gene therapy programs also accepted-- CAMBRIDGE, Mass., April 08, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

developing and commercializing novel tetracyclines

image45

Mon April 8, 2019 7:00 AM|Business Wire|About: TTPH

WATERTOWN, Mass.--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (TTPH) (NASDAQ:TTPH)


 https://www.xerava.com/ 


 XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older. 

TETRAPHASE PHARMACEUTICALS TO PRESENT DATA AT THE 29TH EUROPEAN CONGRESS OF CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASES April 08, 2019 PDF Version WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 8, 2019-- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH)

erdafitinib

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Immunomedics Announces Promotion Agreement With Janssen for Erdafitinib in the U.S.

Mon April 8, 2019 9:00 AM|GlobeNewswire|About: IMMU

MORRIS PLAINS, N.J., April 08, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU), (NASDAQ: IMMU)

Chicago Ill., June 3, 2018 Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer Treatment with investigational compound erdafitinib demonstrated durable responses in patients with metastatic urothelial cancer with genetic alterations

Afirma® Genomic Sequencing Classifier

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Veracyte Announces Publication Highlighting Afirma GSC’s Ability to Rule Out Cancer in Challenging Thyroid Nodule Subtype

Mon April 8, 2019 7:30 AM|Business Wire|About: VCYT

RNA whole-transcriptome and machine learning platform enables genomic test to distinguish benign Hürthle cells, reducing potential for unnecessary surgeries

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc (VCYT)


 https://bmcsystbiol.biomedcentral.com/track/pdf/10.1186/s12918-019-0693-z 

Veracyte Announces Publication Highlighting Afirma GSC’s Ability to Rule Out Cancer in Challenging Thyroid Nodule Subtype RNA whole-transcriptome and machine learning platform enables genomic test to distinguish benign Hürthle cells, reducing potential for unnecessary surgeries April 08, 2019 07:30 AM Eastern Daylight Time SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc

targeted drug delivery (TDD)

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New Study Finds Targeted Drug Delivery (TDD) is Associated with a Reduction in Health Care Utilization and Cost for Cancer Pain Patients

Mon April 8, 2019 8:00 AM|InPublic US|About: MDT 

New Study Finds Targeted Drug Delivery (TDD) is Associated with a Reduction in Health Care Utilization and Cost for Cancer Pain Patients Savings Are Driven by Fewer Inpatient Visits, Shorter Inpatient Length of Stay, and Fewer Emergency Department Visits DUBLIN - April 8, 2019 - Medtronic plc (NYSE:MDT)

seeking biotech alpha April 2019 insight

luspatercept, an erythroid maturation agent

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Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA

Fri April 5, 2019 9:28 AM|Business Wire|About: CELG, XLRN

BLA submission includes both myelodysplastic syndromes and beta-thalassemia indications

EMA marketing application for both indications planned for Q2:19

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Celgene Corporation (CELG) and Acceleron Pharma Inc. (XLRN)

Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA BLA submission includes both myelodysplastic syndromes and beta-thalassemia indications EMA marketing application for both indications planned for Q2:19 April 05, 2019 09:28 AM Eastern Daylight Time SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN)

Phase 3 REGENERATE

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Intercept to Present Results from the First Successful Phase 3 Trial in Patients with Liver Fibrosis Due to NASH at the International Liver Congress™ 2019

Thu April 4, 2019 7:00 AM|GlobeNewswire|About: ICPTGlobeNewswire

NEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (ICPT)

Apr 4, 2019 Intercept to Present Results from the First Successful Phase 3 Trial in Patients with Liver Fibrosis Due to NASH at the International Liver Congress™ 2019 PDF Version Multiple additional abstracts evaluating obeticholic acid (OCA) for the treatment of patients with progressive non-viral liver diseases to be presented at the meeting NEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)

HeartWare(TM) HVAD(TM) System as destination therapy

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 DUBLIN and ORLANDO, Fla. - April 5, 2019 - Medtronic plc (MDT


Medtronic HeartWare(TM) HVAD(TM) System Demonstrates Reduction in Total Strokes, Disabling Strokes and Stroke-Related Mortality with Blood Pressure Management


Fri April 5, 2019 10:00 AM|InPublic US|About: MDT 

Medtronic HeartWare(TM) HVAD(TM) System Demonstrates Reduction in Total Strokes, Disabling Strokes and Stroke-Related Mortality with Blood Pressure Management ompany Has Initiated a Post-Approval Study of Heart Failure Management Best Practices to Further Demonstrate Improved Patient Outcomes DUBLIN and ORLANDO, Fla. - April 5, 2019 - Medtronic plc (NYSE:MDT)

seeking biotech alpha April 2019 insight

IBRANCE® (palbociclib

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U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Thu April 4, 2019 2:57 PM|Business Wire|About: PFE

Approval of expanded indication based predominately on real-world data

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


 https://www.businesswire.com/news/home/20190404005732/en/ 


 https://www.ibrance.com/ 


U.S. FDA APPROVES IBRANCE® (PALBOCICLIB) FOR THE TREATMENT OF MEN WITH HR+, HER2- METASTATIC BREAST CANCER APPROVAL OF EXPANDED INDICATION BASED PREDOMINATELY ON REAL-WORLD DATA Thursday, April 4, 2019 - 2:57pm EDT Pfizer (NYSE:PFE)

VK2809 in patients w/ non-alcoholic fatty liver disease (NAFLD) & elevated low-density (LDL-C)

 Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019

Thu April 4, 2019 7:30 AM|PR Newswire|About: VKTXPR Newswire

SAN DIEGO, April 4, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (VKTX

SAN DIEGO, April 4, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX) NEWS PROVIDED BY Viking Therapeutics, Inc. Apr 04, 2019, 07:30 ET Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019 Late-Breaker Presentation to Highlight Efficacy, Safety and Tolerability Results from 12-Week Phase 2 Trial Including New Data from Study's 5 mg Treatment Arm