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: Douglas W. House, SA News Edito 

  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/ 

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

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

 Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting

Sat October 20, 2018 6:30 PM|Business Wire|About: GILD, GLPG 

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 + Faslodex extends survival in late-stage breast cancer study

Oct. 20, 2018 6:21 PM ET|By: Douglas W. House, 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. 

 Solo-1 Phase III Trial Demonstrates Lynparza Maintenance Therapy Cut the Risk of Disease Progression or Death by 70% in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer

 Sun October 21, 2018 10:33 AM|Business Wire|About: AZN 

 AC Immune Initiates Phase 1 Study of ACI-3024 Small Molecule Tau Morphomer™, an Investigational Treatment for Alzheimer’s Disease

Wed July 17, 2019 7:00 AM|GlobeNewswire|About: ACIU, LLYGlobeNewswire

LAUSANNE, Switzerland, July 17, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (ACIU) (NASDAQ: ACIU)

 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)  

 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 

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),

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/ 

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 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)

  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) 

  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 

 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 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)

 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) 

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) 

 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: Douglas W. House, SA News Editor  

 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)

 Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder

Mon July 15, 2019 7:00 AM|PR Newswire|About: ALKSPR Newswire

DUBLIN, July 15, 2019 /PRNewswire/ -- Alkermes plc (ALKS)

 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 

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

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) 

 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 

  12 July 2019 07:00 BST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).

 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® 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/ - 

 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)

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

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

PR Newswire

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

 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

 Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

Tue July 16, 2019 8:00 AM|PR Newswire|About: ALPMY, SGEN 

 PR Newswire

TOKYO and BOTHELL, Wash., July 16, 2019 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (SGEN) 

 https://www.businesswire.com/news/home/20190716005265/en/ 

 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) 

  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)

 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) 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)-

 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) 

 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 

 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)

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 Pfizer Announces Results from Phase 3 Trial of Revatio® (Sildenafil Citrate) in Newborns with Persistent Pulmonary Hypertension

Fri June 28, 2019 4:05 PM|Business Wire|About: PFE

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

 https://www.businesswire.com/news/home/20190628005244/en/ 

 New Phase 2 Data Show Stelara® (Ustekinumab) Sustained Improvement in Disease Activity in Adults With Systemic Lupus Erythematosus Through One Year

Janssen presents one-year data from continued Phase 2 lupus study during plenary session at ACR/ARHP 2018 Annual Meeting

CHICAGO, October 23, 2018 

 Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance

Mon July 22, 2019 12:00 PM|Business Wire|About: GILD

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

 https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-presents-new-data-on-biktarvy-for-the-treatment-of-hiv-in-women-and-in-virologically-suppressed-patients-with-known-resistance 

 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)

 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)

 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)

  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 

 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/

 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)

 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)

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 --

Merck and Eisai Receive Third Breakthrough Therapy Designation from FDA for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment

Designation Granted for Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment

Tuesday, July 23, 2019 6:45 am EDT 

 https://seekingalpha.com/pr/17579041-merck-eisai-receive-third-breakthrough-therapy-designation-fda-keytruda-pembrolizumab-plus 

 Amgen Makes Repatha® (Evolocumab) Available In The US At A 60 Percent Reduced List Price

 THOUSAND OAKS, Calif., Oct. 24, 2018 – Amgen (NASDAQ:AMGN) 

 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 

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) 

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”)  

 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 

 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)

 October 18, 2018

AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Fresenius Kabi

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. 

  Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials

Jul 31, 2019

 Basel, July 31, 2019 – Novartis today announced Kisqali® (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial.

 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

 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)  

 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 

 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)

 Novartis' Lutathera showed treatment benefit regardless of liver tumor burden in late-stage study; 

Oct. 19, 2018 7:10 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor  

 Kevzara® (sarilumab) Data at the 2018 ACR/ARHP Annual Meeting Provide Additional Insight on Safety and Efficacy in Rheumatoid Arthritis

Fri October 19, 2018 7:00 AM|PR Newswire|About: REGN 

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)

 Oct. 18, 2018 4:18 PM ET|About: Intuitive Surgical, Inc. (ISRG)|By: Douglas W. House, 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%).

 Intuitive Surgical raises procedure growth outlook

Oct. 19, 2018 6:50 AM ET|About: Intuitive Surgical, Inc. (ISRG)|By: Douglas W. House, SA News Editor 

 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 

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)--

 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 

 FDA OK's Medtronic's Valiant Navion TEVAR device

Oct. 23, 2018 9:20 AM ET|About: Medtronic plc (MDT)|By: Douglas W. House, SA News Editor 

 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)

 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 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 

 Clovis' Rubraca shows positive action in late-stage prostate cancer study

Oct. 19, 2018 7:32 AM ET|About: Clovis Oncology (CLVS)|By: Douglas W. House, SA News Editor  

 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 

 Abbott's HeartMate 3 Heart Pump Now FDA Approved for Advanced Heart Failure Patients Not Eligible for a Heart Transplant

Fri October 19, 2018 9:00 AM|PR Newswire|About: ABT 

 FDA Approves Label Update for Genentech’s Rituxan (Rituximab) in Two Rare Forms of Vasculitis

Fri October 19, 2018 11:35 AM|Business Wire|About: RHHBY 

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.  

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/ 

 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")

 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. 

 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) 

 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)  

 ViiV Healthcare's cabotegravir and rilpivirine regimen shows durable treatment effect in mid-stage HIV study

Oct. 29, 2018 7:27 AM ET|By: Douglas W. House, SA News Editor  

 ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY). 

 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., 

 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 

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  

  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)

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)

 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

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

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

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

 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) 

 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 

 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: Douglas W. House, SA News Editor 

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

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

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

 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) 

 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) 

 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)

 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)

 Pfizer, Eli Lilly say their non-opioid drug helps reduce osteoarthritis pain

Oct. 23, 2018 7:13 PM ET|About: Eli Lilly and Company (LLY)|By: Carl Surran, SA News Editor 

Pfizer (NYSE:PFE) and Eli Lilly (NYSE:LLY) say their jointly developed non-opioid drug met all three primary endpoints of a Phase 3 study in which more than half of osteoarthritis patients reported a significant improvement in pain and function of the knee or hip.

 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 

 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)

 Takeda signs $50m Crohn’s deal with French biotech Enterome

Takeda Pharmaceutical Co., which has a major presence in Massachusetts, is based in Japan.

By Jonathan Saltzman GLOBE STAFF  OCTOBER 23, 2018 

 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. 

 AstraZeneca's Lynparza shows positive effect in late-stage ovarian cancer study; 

Oct. 22, 2018 3:41 PM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor 

 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, 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/ -

 Biogen Inc. 2019 Q2 - Results - Earnings Call Slides

Jul. 23, 2019 12:39 PM ET|1 comment | About: Biogen Inc. (BIIB) 

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

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

 JNJ  

 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 

 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 

 Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma

Sun October 21, 2018 6:45 AM|Business Wire|About: INCY 

 Oct. 20, 2018 5:31 PM ET|About: Regeneron Pharmaceutic... (REGN)|By: Douglas W. House, 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 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 

 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