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Tag: fda
FDA: AstraZeneca's diabetes drug showed increased death risk
2015-04-11 13:08:02| Biotech - Topix.net
AstraZeneca PLC's type 2 diabetes drug Onglyza showed an increased risk of death in an analysis by U.S. regulators of a clinical trial on the heart effects of the treatment. Food and Drug Administration staff said their analysis of deaths in the trial suggested patients using Onglyza experienced "significant or near-significant" increases in death from all causes, not just heart problems.
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increased
risk
drug
Stocks Hold Slight Gains; Shire Pops On FDA News
2015-04-09 22:47:07| Industrial Machines - Topix.net
Volume was running slightly lower on the NYSE and slightly higher on the Nasdaq. The Nasdaq and the S&P 500 gained 0.1% and the Dow Jones industrial average was up a smidgen in the stock market today .
Merck's potential HCV drug gets special FDA designation
2015-04-08 14:57:08| Biotech - Topix.net
Merck & Co. said Wednesday that the Food and Drug Administration granted the pharmaceutical company's developing hepatitis C treatment two special designations.
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potential
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designation
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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FDA To Remove Duplicate Product Codes
2015-04-08 10:00:00| Expeditors Newsflash - Americas Edition
Expeditors Newsflash - Americas Edition
Tags: product
remove
codes
duplicate
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