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Tag: investigational
Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone
2015-04-14 19:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. & AMES, Iowa rVSV-ZEBOV-GP (V920) Now Being Studied in Three Key Safety and Efficacy Clinical Trials KENILWORTH, N.J. & AMES, Iowa--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ: NLNK), confirmed today that the third, late-stage, clinical trial of their Ebola vaccine candidate rVSV-ZEBOV-GP (V920) has been initiated in Sierra Leone. The vaccine candidate was originally developed by the Public Health Agency of Canadas National Microbiology Laboratory and licensed to NewLink Genetics in 2010. On Nov. Language: English Contact: Merck Media:Pam Eisele, 267-305-3558orImraan Munshi, 215-652-0059Investor:NewLink Genetics:Jack Henneman, 515-598-2561orMerck:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: NLNK Exchange: NASDAQ read more
Grazoprevir/Elbasvir, Mercks Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015
2015-04-08 13:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During First Half of 2015 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1879Justin Holko, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Baxter BioScience Announces Positive Phase III Results For BAX 817, Investigational Recombinant Treatment For Hemophilia A And B Patients With Inhibitors
2015-04-01 07:33:48| drugdiscoveryonline Home Page
Baxter International Inc. recently announced positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa (rFVIIa) treatment for people with hemophilia A or B who develop inhibitors
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New Analysis from Investigational IMPROVE-IT Study Shows VYTORIN (ezetimibe/simvastatin) Reduced Total (Initial and Recurrent) Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes
2015-03-16 20:30:00| Merck.com - Product News
Dateline City: SAN DIEGO SAN DIEGO--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a pre-specified exploratory analysis of the investigational IMPROVE-IT study of more than 18,000 patients presenting with acute coronary syndromes. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orMichael Close, 267-305-1211orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection
2015-03-13 21:02:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Mercks investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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