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Merck Receives FDA Approval of ZEPATIER (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
2016-01-29 00:59:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. ZEPATIER Achieves High Cure Rates (SVR12) in Broad Range of Patients with Chronic Hepatitis C Infection, Including Those with Compensated Cirrhosis, Renal Impairment of Any Degree and HIV-1/HCV Co-infection KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 201-669-6570orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck Completes Enrollment in Pivotal Phase 3 EPOCH Trial Investigating the Efficacy and Safety of Verubecestat in Patients with Mild-to-Moderate Alzheimers Disease
2016-01-28 14:00:26| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. APECS Study Investigating Verubecestat in Patients with Prodromal Alzheimers Ongoing KENILWORTH, N.J. -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed the completion of enrollment for the EPOCH trial, a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study of verubecestat, formerly known as MK-8931, the companys investigational oral small molecule selective beta secretase (BACE1) inhibitor, in patients with mild-to-moderate Alzheimers disease (AD). The ongoing study commenced in November 2012, completed enrollment in the fourth quarter of 2015 and is estimated to reach primary trial completion in July 2017. Language: English read more
Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence
2016-01-27 14:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. FDA Grants Priority Review with Target Action Date of July 23, 2016 Marketing Authorization Application Also Filed with the European Medicines Agency KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck KGaA, Darmstadt, Germany and BrandWatch Technologies Form Long-Term Partnership
2016-01-25 06:00:00| Coatings World Breaking News
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Merck pays $830 M to settle class-action case over Vioxx
2016-01-15 18:00:06| Biotech - Topix.net
Merck will pay $830 million to resolve a federal class-action lawsuit involving shareholders and the painkiller Vioxx, which the drugmaker pulled from the market years ago over safety concerns. Merck said Friday that the case involved people who purchased its securities between 1999 and 2004.
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