seeking biotech alpha April 2019 insight

Novartis AG (NVS)

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 Novartis AG 2019 Q1 - Results - Earnings Call Slides

Apr. 24, 2019 6:32 AM ET | About: Novartis AG (NVS) 

Biogen Inc. (BIIB)

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 Biogen Inc. 2019 Q1 - Results - Earnings Call Slides

Apr. 24, 2019 7:10 AM ET  | About: Biogen Inc. (BIIB) 

Thermo Fisher Scientific Inc. (TMO)

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Thermo Fisher Scientific Inc. 2019 Q1 - Results - Earnings Call Slides

Apr. 24, 2019 9:49 AM ET | About: Thermo Fisher Scientific Inc. (TMO) 

Boston Scientific Corporation (BSX)

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Boston Scientific Corporation 2019 Q1 - Results - Earnings Call Slides

Apr. 24, 2019 9:50 AM ET|1 comment | About: Boston Scientific Corporation (BSX) 

Trulicity® (dulaglutide)

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Trulicity® (dulaglutide) significantly reduced major cardiovascular events for broad range of people with type 2 diabetes

Sun June 9, 2019 7:30 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, June 9, 2019 /PRNewswire/ 

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)

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.

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 

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 

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%

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 

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 

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). 

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 

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)

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)

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)

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

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 

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 

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

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/ 


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)

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) 

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

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/ 

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)

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 

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) 

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)

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/ 

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 

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)

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)  

Geron Corporation (GERN)

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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  

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 

developing and commercializing novel tetracyclines

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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. 

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)

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 

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 

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)

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)

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 

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/ 


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