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
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
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
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
VANCOUVER, British Columbia--(BUSINESS WIRE)
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)
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
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
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)
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
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
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/ -
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)
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
WHIPPANY, N.J. & PRINCETON, N.J. & OSAKA, Japan--(BUSINESS WIRE)-- Bayer, Bristol-Myers Squibb Company (BMY) (NYSE: BMY)
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
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
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.
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41.23 - 52.83
Market Cap.
120.97B
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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
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)
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/
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
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
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
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