seeking biotech alpha July 2019 & October 2018 insight

TECENTRIQ (atezolizumab) plus ABRAXANE (nab-paclitaxel)

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 Roche's Tecentriq extends progression-free survival in first-line TNBC

 Results from a Phase 3 clinical trial, IMpassion130, evaluating Roche (OTCQX:RHHBY) unit Genentech's TECENTRIQ (atezolizumab) plus Celgene's (NASDAQ:CELG) ABRAXANE (nab-paclitaxel) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) showed a treatment effect. The data were presented at ESMO in Munich. 

Oct. 20, 2018 7:28 PM ET|By: , SA News Edito 


KEYTRUDA® (pembrolizumab)

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  Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC)

Mon July 29, 2019 6:55 AM|Business Wire|About: MRK 


 https://www.businesswire.com/news/home/20190729005182/en/ 

Opdivo (nivolumab) + Yervoy (ipilimumab)

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 Unique combination of Opdivo + Yervoy shows encouraging action in Phase 1/2 bladder cancer study

Oct. 20, 2018 6:09 PM ET|By: , SA News Editor 

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

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European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Mon July 29, 2019 6:30 AM|Business Wire|About: MRK

Opinion Granted Based on Significant Overall Survival Benefit for KEYTRUDA in Combination with Axitinib Compared to Sunitinib in Phase 3 KEYNOTE-426 Trial

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

IBRANCE (palbociclib) and FASLODEX (fulvestrant)

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 Ibrance + Faslodex extends survival in late-stage breast cancer study

Oct. 20, 2018 6:21 PM ET|By: , SA News Editor 

 Pfizer (NYSE:PFE) announces overall survival (OS) data from the Phase 3 PALOMA-3 trial evaluating the combination of IBRANCE (palbociclib) and AstraZeneca's (NYSE:AZN) FASLODEX (fulvestrant) in women with HR+/HER2- metastatic breast cancer who progressed on or after prior endocrine therapy, an indication approved in the U.S. in March. 

seeking biotech alpha July 2019 & October 2018 insight

OPDIVO® (nivolumab) + YERVOY® (ipilimumab)

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 Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

  • CATEGORY: 

CORPORATE/FINANCIAL NEWSMONDAY, OCTOBER 22, 2018 

6:45 AM EDT 

 PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY)  

LOKELMA™ (sodium zirconium cyclosilicate)

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 AstraZeneca to Present New Data Demonstrating Breadth of Research Portfolio in Renal Disease at ASN Kidney Week 2018

Mon October 22, 2018 7:00 AM|Business Wire|About: AZN 

RECARBRIO™ (imipenem, cilastatin, and relebactam)

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FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available

Wed July 17, 2019 6:45 AM|Business Wire|About: MRK

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

AzymetricTM platform

image133

Celgene Selects Lead Oncology Therapeutic Candidate Under Bispecific Antibody Collaboration with Zymeworks

Tue July 16, 2019 8:30 AM|Business Wire|About: ZYME

  • First of ten potential products built on Zymeworks’ proprietary AzymetricTMplatform
  • Zymeworks (ZYME) to receive US$7.5 million commercial license payment

VANCOUVER, British Columbia--(BUSINESS WIRE)


 https://www.businesswire.com/news/home/20190716005225/en/ 

seeking biotech alpha July 2019 insight

MitraClip™ heart valve repair device

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Abbott Receives U.S. Approval of Next-Generation MitraClip®, Bringing New Enhancements to Abbott's Leading MitraClip Platform

Mon July 15, 2019 12:46 PM|PR 

Newswire|About: ABT

- G4 includes new clip sizes and an enhanced leaflet grasping feature

PR Newswire

ABBOTT PARK, Ill., July 15, 2019 /PRNewswire/ -- Abbott (ABT)

Intuitive (ISRG)

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 Intuitive Surgical acquires Schölly Fiberoptic’s robotic endoscope business

Mon July 15, 2019 4:15 PM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif. and DENZLINGEN, Germany, July 15, 2019 (GLOBE NEWSWIRE) -- Intuitive (ISRG)

Emgality® (galcanezumab-gnlm)

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  AHS 2019: Post-Hoc Analyses of Phase 3 Pivotal Studies of Emgality® (galcanezumab-gnlm) Show Improvements in Daily Functioning and Reductions in Disability in Patients with Chronic and Episodic Migraine

Fri July 12, 2019 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, July 12, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY

crizanlizumab (SEG101)

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  FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)

Jul 16, 2019

  • FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months
     
  • Vaso-occlusive crises (also called sickle cell pain crises) are unpredictable and extremely painful events that can lead to serious life-threatening complications and death[1]

Basel, July 16, 2019 -


 https://seekingalpha.com/news/3477970-fda-accepts-novartis-application-sickle-cell-med-crizanlizumab 

Dovato (dolutegravir Plus Lamivudine)

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 ViiV Healthcare Announces Phase III Study Meets Primary Endpoint, Demonstrating the Ability to Control HIV-1 With the 2-drug Regimen Dovato (dolutegravir Plus Lamivudine) in Virally Suppressed Patients Switching From a TAF-containing, 3-drug Regimen

Wed July 10, 2019 2:15 AM|Business Wire|About: GSK, PFE 

Gilead Sciences and Renown Institute for Health Innovation

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 Gilead Sciences and Renown Institute for Health Innovation Announce Strategic Collaboration to Advance Understanding of Nonalcoholic Steatohepatitis (NASH)

Thu July 11, 2019 8:30 AM|Business Wire|About: GILD

FOSTER CITY, Calif. & RENO, Nev.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and the Renown Institute for Health Innovation (IHI)

seeking biotech alpha July 2019 insight

AbbVie (ABBV) announced today that it has acquired Seattle-based Mavupharma,

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 AbbVie Enhances Early Stage Oncology Pipeline with Acquisition of Mavupharma

Mon July 15, 2019 8:00 AM|PR Newswire|About: ABBV

NORTH CHICAGO, Ill., July 15, 2019 /PRNewswire/ -- AbbVie (ABBV

Valoctocogene Roxaparvovec

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BioMarin Plans Regulatory Submissions for Marketing Authorization of Valoctocogene Roxaparvovec to Treat Severe Hemophilia A in 4Q 2019 in both U.S. and Europe

Mon July 8, 2019 8:01 AM|PR Newswire|About: BMRN

Late-Breaking Abstract at the 27th International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress Presents 3 Years of Efficacy and Safety of Valoctocogene Roxaparvovec

PR Newswire

SAN RAFAEL, Calif., July 8, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN

BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) + Eli Lilly's ERBITUX (cetuximab)

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 Array BioPharma Announces Interim Analysis Results from the BEACON CRC Trial of BRAFTOVI + MEKTOVI + Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer at the ESMO 21st World Congress on Gastrointestinal Cancer

Sat July 6, 2019 5:19 AM|PR Newswire|About: ARRY

- Data supports potential to be the first chemotherapy-free, targeted regimen for BRAF-mutant mCRC patients -

- Results were presented in an oral presentation today, July 6, 2019 -

PR Newswire

BOULDER, Colo., July 6, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY


Array Bio's triplet therapy extends survival in late-stage CRC study

Jul. 8, 2019 7:33 AM ET|About: Array BioPharma Inc. (ARRY)|By: , SA News Editor  

Vascepa® (icosapent ethyl)

image143

 Amarin Provides Mid-2019 Update, Including Commercialization Plans for Vascepa® and Updates Full Year 2019 Revenue Guidance

Tue July 2, 2019 6:00 AM|GlobeNewswire|About: AMRN

  • Record Revenue Achieved in 1H19 Primarily Due to Increased Demand for Vascepa
  • Guidance for Total 2019 Revenue Increased to a Range of $380 to $420 Million from $350 Million Following Unaudited Second Quarter Results Estimated Between $97 and $101 Million, or Between $170 and $174 Million for the First Half of 2019
  • U.S. Sales Force to Double in Size; Recruiting Commenced
  • Vascepa sNDA PDUFA Goal Date On-Track for September 28, 2019; Potential for Therapy to Become First Prescription Product Available for Cardiovascular Risk Reduction in Patients with Elevated Triglyceride Levels, Despite Statin Therapy

BEDMINSTER, N.J. and DUBLIN, Ireland, July 02, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

XOFLUZA (Baloxavir Marboxil)

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 Genentech Announces Positive Results for First Global Phase III Study Investigating One-dose XOFLUZA (Baloxavir Marboxil) in Children With the Flu

Wed July 3, 2019 1:00 AM|Business Wire|About: RHHBY 

seeking biotech alpha July 2019 insight

Opicapone

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Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease

Wed July 10, 2019 4:10 PM|PR Newswire|About: NBIX

- Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 26, 2020

Alinity™ s System.

image147

Abbott Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply

Thu July 11, 2019 9:00 AM|PR Newswire|About: ABTPR Newswire

ABBOTT PARK, Ill., July 11, 2019 /PRNewswire/ -- Abbott (ABT

KEYTRUDA® (pembrolizumab)

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 FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

Tue July 9, 2019 6:45 AM|Business Wire|About: MRK

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


 https://www.merck.com/clinical-trials/index.html 

Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF)

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 Gilead and Galapagos Enter Into Transformative Research and Development Collaboration

Sun July 14, 2019 1:00 PM|Business Wire|About: GILD, GLPG

– Gilead to Make $3.95 Billion Upfront Payment and $1.1 Billion Equity Investment –

– Gilead Gains Access to Galapagos’ Differentiated Drug Discovery Platform and Current and Future Pipeline Outside of Europe –

– Investment Enables Galapagos to Expand and Accelerate Research and Clinical Programs –

– Galapagos Gains Broader Commercialization Role for Filgotinib in Europe and Agrees to Share Equally in Future Development Costs –

– Gilead Agrees to 10-year Standstill –

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF)

ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated)

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 ESPEROCT® is now approved in Canada for the Treatment of Hemophilia A in both Children and Adults

Fri July 12, 2019 7:00 AM|Canada Newswire|About: NVO

New treatment can help Canadians living with hemophilia A better manage their bleeding episodes

TORONTO, July 12, 2019 /CNW/ - 

Seeking biotech alpha July 2019 & October 2018 insight

BMS-986179 With Enhanze®

image152

 Halozyme Announces First Clinical Dosing In Bristol-Myers Squibb's Phase 1 Trial Of BMS-986179 With Enhanze® Technology

Thu October 25, 2018 8:00 AM|PR Newswire|About: BMY, HALO

SAN DIEGO, Oct. 25, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO)

Home Hemodialysis Device

image153

CVS Health Announces Start of Clinical Trial for New Home Hemodialysis Device

Wed July 17, 2019 8:00 AM|PR Newswire|About: CVS

Represents next step in company-wide strategy to help improve kidney disease diagnosis and management

PR Newswire

WOONSOCKET, R.I., July 17, 2019 /PRNewswire/ -- CVS Health (CVS)

BAN2401, an anti-amyloid beta protofibril antibody,

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 Eisai and Biogen Announce Presentation of Additional Data From the Phase II Clinical Trial of BAN2401 in Early Alzheimer’s Disease at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Thu October 25, 2018 8:31 AM|GlobeNewswire|About: BIIB

TOKYO and CAMBRIDGE, Mass., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (BIIB) (Headquarters: Cambridge, Massachusetts, United States

Influenza A & B 2 and Strep A 2 molecular assays

image156

 Abbott Introduces the Next Generation of Influenza A & B and Strep A Assays with Fastest-Ever Time to Molecular Results

Thu October 25, 2018 9:00 AM|PR Newswire|About: ABTPR Newswire

ABBOTT PARK, Ill., Oct. 25, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) 

Stivarga® (regorafenib) and Opdivo® (nivolumab)

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  Bayer, Bristol-Myers Squibb and Ono Pharmaceutical Enter Into a Clinical Collaboration Agreement to Investigate Stivarga® (regorafenib) and Opdivo® (nivolumab) as Combination Therapy in Patients With Metastatic Colorectal Cancer

Thu July 18, 2019 6:30 AM|Business Wire|About: BMY

  • Combination of regorafenib and nivolumab vs. regorafenib alone to be evaluated in patients with micro-satellite stable metastatic colorectal cancer
  • Companies plan indication-seeking trial

WHIPPANY, N.J. & PRINCETON, N.J. & OSAKA, Japan--(BUSINESS WIRE)-- Bayer, Bristol-Myers Squibb Company (BMY) (NYSE: BMY)

Seeking Biotech Alpha June 2019 Insight

ZIRABEV™ (bevacizumab-bvzr)

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 Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)

Fri June 28, 2019 7:33 AM|Business Wire|About: PFE

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

IMFINZI® (durvalumab)

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 IMFINZI® (durvalumab) Improves Overall Survival at Interim Analysis in the Phase III CASPIAN Trial in 1st-Line Extensive-Stage Small Cell Lung Cancer

Thu June 27, 2019 8:56 AM|Business Wire|About: AZN

Trial showed statistically-significant and clinically meaningful benefit in patients with the most aggressive type of lung cancer

WILMINGTON, Del.--(BUSINESS WIRE)-

SOLIRIS® (eculizumab)

image160

 Alexion Receives FDA Approval of SOLIRIS® (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are Anti-Aquaporin-4 (AQP4) Antibody Positive

Thu June 27, 2019 2:11 PM|Business Wire|About: ALXN

- At 48 weeks, 98% of patients treated with SOLIRIS were relapse free compared to 63% of patients receiving placebo -

- SOLIRIS is the first and only FDA approved treatment for this rare, severe, condition that attacks the central nervous system without warning -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN

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

image161

 Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible

  • Combination regimen reduced the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible
  • Marks the sixth DARZALEX FDA-approved use in multiple myeloma and second for newly diagnosed patients

HORSHAM, Pa., June 27, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson 

Victoza® (liraglutide)

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 FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years

PLAINSBORO, N.J., June 17, 2019 /PRNewswire/ -- Novo Nordisk


 Novo Nordisk A/S (NVO)

NVO
$51.04
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Novo Nordisk A/S
Novo Nordisk A/S, a healthcare company, engages in the development, manufacture, and marketing of pharmaceutical products worldwide.
52 Week Range
41.23 - 52.83
Market Cap.
120.97B
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(30,945 followers)

seeking biotech alpha July 2019 & October 2018 insight

Bioinformatics Hub

image166

 Intrexon Announces the Formation of Bioinformatics Hub in Munich

Wed October 24, 2018 7:30 AM|PR Newswire|About: XONPR Newswire

GERMANTOWN, Md., Oct. 24, 2018 /PRNewswire/ -- Intrexon Corporation(NASDAQ: XON)

Zanubrutinib

image167

 BeiGene Announces Acceptance of its New Drug Application in China and Top-Line Pivotal Data for Zanubrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Wed October 24, 2018 7:00 AM|GlobeNewswire|About: BGNE

BEIJING, China, and CAMBRIDGE, Mass., Oct. 24, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

Medtronic SynchroMed™ II pump

image168

 FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain

(GLOBE NEWSWIRE via COMTEX) --myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician

DUBLIN - October 24, 2018 - Medtronic plc (NYSE:MDT)

F.I.R.S.TTM technology platform

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  BioInvent Announces Selection of First Target Discovered by BioInvent's Proprietary F.I.R.S.TTM Technology Platform Under Collaboration With Pfizer Inc.

Wed July 31, 2019 7:09 AM|PR Newswire|About: PFE 


 LUND, Sweden, July 31, 2019 /PRNewswire/ -- BioInvent International AB (BOVNF) ("BioInvent" or the "Company") (OMXS: BINV) today announces that Pfizer Inc. (PFE) ("Pfizer") (NYSE: PFE) 


 https://www.prnewswire.com/news-releases/bioinvent-announces-selection-of-first-target-discovered-by-bioinvents-proprietary-firsttm-technology-platform-under-collaboration-with-pfizer-inc-300893953.html 

Seeking biotech alpha July 2019 & October 2018 insight

EYLEA® (aflibercept)

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 EYLEA® (aflibercept) Injection Improves Diabetic Retinopathy and Reduces Vision-Threatening Complications in Phase 3 Trial

Thu October 25, 2018 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Oct. 25, 2018 /PRNewswire/

Ruxolitinib (Jakafi®)

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 FDA Grants Priority Review for Ruxolitinib (Jakafi®) as a Treatment for Patients with Acute Graft-Versus-Host Disease

Thu October 25, 2018 7:30 AM|Business Wire|About: INCY

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (INCY)

Islatravir (MK-8591)

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 Merck Announces Presentation of Phase 2b Results for Investigational HIV-1 Therapy Islatravir (MK-8591) at IAS 2019

Wed July 24, 2019 11:00 AM|Business Wire|About: MRK

New Findings from Study Evaluating Islatravir in Combination with Doravirine versus DELSTRIGO™ (doravirine 100 mg/3TC 300 mg/tenofovir disoproxil fumarate 300 mg)

Company Plans to Initiate Phase 3 Trials

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

XOFLUZA ™ (BALOXAVIR MARBOXIL)

image173

 

Wednesday, Oct 24, 2018

Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza

First and only single-dose oral medicine approved to treat the flu 
XOFLUZA significantly reduced the duration of flu symptoms compared to placebo
First novel proposed mechanism of action to treat the flu in nearly 20 years

South San Francisco, CA -- October 24, 2018 --

seeking biotech alpha July 2019 & October 2018 insight

Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib)

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 Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib) Significantly Improved Overall Survival (OS) and Progression-free Survival (PFS) as First-Line Therapy for Advanced or Metastatic Renal Cell Carcinoma

Thu October 18, 2018 6:57 AM|Business Wire|About: MRK 

Respiratory and Herpes Antiviral

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Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis

Fri July 19, 2019 8:30 AM|Business Wire|About: GILD

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

vedolizumab

Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease

Mon July 22, 2019 1:00 AM|Business Wire|About: TAK

Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)

OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK) (“Takeda”)  

Alzheimer’s Disease

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 Biogen to Present Data from Alzheimer’s Disease Portfolio at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting

Thu October 18, 2018 7:30 AM|GlobeNewswire|About: BIIB 

ZERBAXA® 3g Dose (ceftolozane and tazobactam)

image179

 Merck Receives Positive EU CHMP Opinion for ZERBAXA® 3g Dose (ceftolozane and tazobactam) for the Treatment of Adults with Hospital-Acquired Pneumonia (HAP), Including Ventilator-Associated Pneumonia (VAP)

Mon July 29, 2019 4:05 PM|Business Wire|About: MRK

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

seeking biotech alpha July 2019 & October 2018 insight

Tamiflu®

image181

Sanofi signs strategic deal for exclusive US over-the-counter rights to Tamiflu® in Flu Care

Tue July 23, 2019 1:00 AM|GlobeNewswire|About: SNY

 Sanofi (SNY) signs strategic deal for exclusive US over-the-counter rights to Tamiflu® in Flu Care

PARIS – July 23, 2019 – Sanofi signed an agreement with Roche for the exclusive over-the-counter (OTC) rights to Tamiflu® for the prevention and treatment of influenza or flu in the US. 

JNJ to open JPOD hub at UPenn’s Pennovation Center in Philadelphia

image183

 The University of Pennsylvania Announces Agreement with Johnson & Johnson Innovation to Launch JPOD @ Philadelphia

 

Pennovation Media Contact: Jennifer Rizzi, Director, Communications, Facilities & Real Estate Services, 215.573.6107, rizzi@upenn.edu

July 18, 2018

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

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 Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy

Tue October 30, 2018 6:36 AM|Business Wire|About: GILD 

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

ALKS 5461 (buprenorphine/samidorphan)

image185

 Alkermes Announces Publication of Phase 3 Data for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder in Molecular Psychiatry

 DUBLIN, Oct. 29, 2018 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS)  

Mon October 29, 2018 1:13 PM|PR Newswire|About: ALKS 

OTEZLA® (apremilast)

image186

 FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Fri July 19, 2019 1:59 PM|Business Wire|About: CELG

OTEZLA reduced the number and pain of oral ulcers in the 12-week placebo-controlled Phase 3 RELIEF™ study

With this third indication in the U.S., OTEZLA is the first and only treatment approved for oral ulcers associated with Behçet’s Disease

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

seeking biotech alpha July 2019 & October 2018 insight

Bimatoprost Sustained-Release (SR)

image189

U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension

Wed July 17, 2019 7:30 AM|PR Newswire|About: AGN

-- Allergan continues advancement in eye care innovation, developing specialized treatments for patients --

PR Newswire

DUBLIN, July 17, 2019 /PRNewswire/ -- Allergan plc (AGN)


Intuitive Surgical, Inc. (ISRG)

image190

 Oct. 18, 2018 4:18 PM ET|About: Intuitive Surgical, Inc. (ISRG)|By: , SA News Editor 

Intuitive Surgical (NASDAQ:ISRG) Q3 results ($M): Revenue: 920.9 (+14.0%); Instruments & accessories: 486.3 (+21.2%); Systems: 274.6 (+4.8%); Services: 160.0 (+10.7%).

Net income: 292.5 (-2.0%); non-GAAP net income: 337.0 (+3.7%); EPS: 2.45 (-4.3%); non-GAAP EPS: 2.83 (+1.8%).

da Vinci system shipments: 231 (+36.7%).

Temozolomide

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 BeiGene Presents Preliminary Clinical Data on PARP Inhibitor Pamiparib in Combination with Low-Dose Temozolomide in Patients with Solid Tumors at European Society for Medical Oncology (ESMO) 2018 Congress

Mon October 22, 2018 7:15 AM|GlobeNewswire|About: BGNE 

seeking biotech alpha July 2019 & October 2018 insight

IMFINZI® (durvalumab)

image193

IMFINZI® (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer

Mon July 22, 2019 8:00 AM|Business Wire|About: AZN

IMFINZI is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy

WILMINGTON, Del.--(BUSINESS WIRE)--

Upadacitinib (ABT-494)

image194

 AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data

Tue October 23, 2018 9:00 AM|PR Newswire|About: ABBV 

EPIDYOLEX™ (cannabidiol oral solution)

image196

 GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX™ (cannabidiol oral solution) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy

Fri July 26, 2019 6:37 AM|GlobeNewswire|About: GWPH

If approved cannabidiol oral solution will be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy

GW’s cannabidiol oral solution contains highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the “high” associated with cannabis


LONDON and CARLSBAD, Calif., July 26, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (Nasdaq: GWPH)

RUXIENCE™ (RITUXIMAB-PVVR)

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 FDA APPROVES PFIZER’S BIOSIMILAR, RUXIENCE™ (RITUXIMAB-PVVR), FOR CERTAIN CANCERS AND AUTOIMMUNE CONDITIONS

Tuesday, July 23, 2019 - 1:48pmEDT

Pfizer Inc. (NYSE:PFE) t

Medtronic Partners with Viz.ai

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Medtronic Partners with Viz.ai to Accelerate Adoption of New Artificial Intelligence Software in U.S. Stroke Centers

July 22, 2019 | About: MDT +0% 


Technology Has the Potential to Save Crucial Time and Increase Access to Lifesaving Stroke Treatments

DUBLIN and SAN FRANCISCO, July 22, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (:MDT)


 http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2404287 

seeking biotech alpha July 2919 & October 2018 insight

ALUNBRIG® (brigatinib)

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 Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer

Fri October 19, 2018 8:00 AM|Business Wire|About: TKPYY 

Dengvaxia

 

Sanofi receives positive CHMP opinion for dengue vaccine

Paris, France - October 19, 2018 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Sanofi's dengue vaccine, recommending its approval in Europe.  

VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

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Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis

Mon July 22, 2019 8:00 AM|Business Wire|About: VRTX

-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations-

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (VRTX


 https://www.businesswire.com/news/home/20190722005202/en/ 

seeking biotech alpha October 2018 insight

XIFAXAN® (rifaximin)

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 Salix And Alfasigma Will Initiate Late-Stage Program To Study Rifaximin In Patients With Postoperative Crohn's Disease

Mon October 29, 2018 7:00 AM|PR Newswire|About: BHC

Companies Announce Resolution of Outstanding Arbitration

BRIDGEWATER, N.J., Oct. 29, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Inc. ("Salix")

tropifexor

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 Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH

Mon October 29, 2018 2:15 AM|Business Wire|About: NVS, PFE 

 Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist. 

ActoBiotics® Lactococcus lactis

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 ActoBio Therapeutics™ Doses First Patient in Phase Ib/IIa Clinical Study of AG019 for the Treatment of Type 1 Diabetes

Mon October 29, 2018 7:30 AM|PR Newswire|About: XONPR Newswire

GHENT, Belgium, Oct. 29, 2018 /PRNewswire/ -- ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NASDAQ: XON) 

GalXC™ RNAi technology

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 Lilly and Dicerna Announce RNAi Licensing and Research Collaboration

Mon October 29, 2018 6:00 AM|PR Newswire|About: DRNA, LLY 

 INDIANAPOLIS and CAMBRIDGE, Mass., Oct. 29, 2018 /PRNewswire/ -- Eli Lilly and Company (LLY) and Dicerna Pharmaceuticals (DRNA)  

Thermo Fisher Scientific Inc. TMO

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 Thermo Fisher Scientific Opens Newly Expanded Facility in Frederick, Md.

Mon October 29, 2018 8:30 AM|PR Newswire|About: TMOPR Newswire

FREDERICK, Md., Oct. 29, 2018 /PRNewswire/ -- Thermo Fisher Scientific Inc., 

seeking biotech alpha July 2019 & October 2018 insight

faricimab (RG7716)

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 New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

 

South San Francisco, CA -- October 27, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 RHHBY 

Repatha® (Evolocumab)

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Amgen Announces New FOURIER Analysis Showing Benefit With Repatha® (Evolocumab) In High-Risk Patients With Established Cardiovascular Disease And Chronic Kidney Disease

 THOUSAND OAKS, Calif., Oct. 26, 2018

 /PRNewswire/ -- Amgen (NASDAQ:AMGN) 

 Repatha Results in Consistent 

Reductions in LDL-C Levels and Cardiovascular Events in Patients Independent of Kidney Function
Results Presented at American Society of Nephrology Kidney Week 2018

 AMGN  

Nubeqa® (darolutamide)

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  FDA approves Bayer's Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer

- Nubeqa was approved under the FDA's Priority Review designation; approval granted three months ahead of target FDA action date

- Approval based on Phase III ARAMIS trial evaluating the efficacy and safety of Nubeqa plus androgen deprivation therapy (ADT) compared to placebo plus ADT(1)

brolucizumab (RTH258)

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Novartis is going after a $5 billion market with a new treatment for vision loss. That's a big threat to Regeneron

Lydia Ramsey 20h - Business Insider
 (NVS)

ZYTIGA® (abiraterone acetate)

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 Court Issues Ruling in ZYTIGA® Patent Infringement Litigation

Fri October 26, 2018 5:48 PM|PR Newswire|About: JNJ

NEW BRUNSWICK, N.J., Oct. 26, 2018 /PRNewswire

capmatinib

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 Novartis' capmatinib shows positive effect in mid-stage lung cancer study

Oct. 22, 2018 10:37 AM ET|By: , SA News Editor 

 Novartis in-licensed capmatinib, an oral MET inhibitor, from Incyte (INCY) in 2009. 

seeking biotech alpha July 2019 & October 2018 insight

diroximel fumarate

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 Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis

Tue July 30, 2019 7:30 AM|PR Newswire|About: ALKS, BIIB 


 PR Newswire

DUBLIN and CAMBRIDGE, Mass., July 30, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS) and Biogen Inc. (BIIB


Aducanumab (BIIB037)

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 Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)

Fri October 26, 2018 9:15 AM|GlobeNewswire|About: BIIB 

Oral Semaglutide

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 Novo Nordisk's oral semaglutide successful in late-state T2D study

Oct. 26, 2018 9:14 AM ET|About: Novo Nordisk A/S (NVO)|By: , SA News Editor 

BioMarin Pharmaceutica (BMRN)

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 BioMarin Pharma Q3 top line up 17%; Vimizim sales up 37%

Oct. 25, 2018 4:27 PM ET|About: BioMarin Pharmaceutica... (BMRN)|By: , SA News Editor 

BioMarin Pharmaceutical (NASDAQ:BMRN) Q3 results ($M): Revenues: 391.7 (+17.2%); Product sales: 386.3 (+29.3%).

Regeneron Pharmaceuticals, Inc. (REGN)

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 October 26, 2018 at 7:00 AM EDT REGENERON RANKED #1 BIOPHARMA EMPLOYER FOR SIXTH TIME BY SCIENCE MAGAZINE

TARRYTOWN, N.Y., Oct. 26, 2018 /PRNewswire/ --

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN 

Regeneron Pharmaceuticals, Inc. (REGN

TLR7 agonists vesatolimod (GS-9620) and GS-986

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 July 23, 2019 

Gilead Announces Latest Data in Ongoing HIV Cure Research Program

New Studies Evaluate Agents with Potential Role in Eliminating HIV Viral Reservoir

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 23, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) 

seeking biotech alpha July 2019 & October 2018 insight

REVLIMID® (lenalidomide)

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 REVLIMID® (lenalidomide) Demonstrated a Significant Improvement in Progression-Free Survival (PFS) Compared with Observation in a Randomized Study in Patients with Smoldering Multiple Myeloma

Tue October 23, 2018 4:30 PM|Business Wire|About: CELG

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

Verzenio® (abemaciclib)

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 Lilly's Verzenio® (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2

07/30/2019 

 Verzenio is the first and only CDK4 & 6 inhibitor in combination with fulvestrant to achieve statistically significant improvement in overall survival
MONARCH 2 was a Phase 3 study including both pre/peri- and postmenopausal women whose cancer progressed following endocrine therapy

INDIANAPOLIS, July 30, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Vedolizumab

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 Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis

October 22, 2018 Osaka, Japan 

INGREZZA® (valbenazine)

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 Neurocrine Biosciences to Present New Data Analyses on the Long-Term Effects of INGREZZA® (valbenazine) in Tardive Dyskinesia Patients with Mood Disorders at the 2018 Annual Psych Congress

Tue October 23, 2018 4:01 PM|PR Newswire|About: NBIXPR Newswire

SAN DIEGO, Oct. 23, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)

seeking biotech alpha July 2019 & October 2018 insight

dapirolizumab pegol (DZP)

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 BRUSSELS, Belgium and CAMBRIDGE, Mass., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Today UCB (Euronext Brussels: UCB) and Biogen Inc (BIIB). (Nasdaq: BIIB) announced top-line results from a Phase 2b study evaluating the safety and efficacy of dapirolizumab pegol (DZP), an anti-CD40L pegylated Fab, in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants. 

Upadacitinib (ABT-494)

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 Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis

Mon October 22, 2018 6:01 PM|PR Newswire|About: ABBV 

BAQSIMI™ (glucagon) Nasal Powder 3 mg

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BAQSIMI™ (glucagon) Nasal Powder 3 mg, the First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia in Adults and Children with Diabetes Ages Four Years and Older, Approved by FDA

Wed July 24, 2019 11:19 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, July 24, 2019 /PRNewswire/ -

Johnson & Johnson (JNJ)

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 J&J makes $2.1B offer to buy out Ci:z

Oct. 23, 2018 4:58 AM ET|By: , SA News Editor  

 JNJ  

seeking biotech alpha October 2018 insight

IBRANCE® (palbociclib)

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 Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer

Sat October 20, 2018 10:30 AM|Business Wire|About: PFE 

Entrectinib

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 Genentech’s Investigational Personalized Medicine Entrectinib Shrank Tumors in People with NTRK Fusion-Positive Solid Tumors

Sun October 21, 2018 5:00 AM|Business Wire|About: RHHBY 

DUPIXENT®

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 Oct. 20, 2018 5:31 PM ET|About: Regeneron Pharmaceutic... (REGN)|By: , SA News Editor 

The FDA approves Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi's (NYSE:SNY) DUPIXENT (dupilumab) as add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Larotrectinib

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 Larotrectinib Delivers 81% Overall Response Rate in an Expanded Dataset of 109 TRK Fusion Cancer Patients Across Ages and Tumor Types

Sun October 21, 2018 5:12 AM|PR Newswire|About: LOXO 

TEVA

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 Sun October 21, 2018 8:23 AM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-

 Teva and New Jersey Governor Murphy Formalize North America Headquarters Move with Ceremony in Israel