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Enanta Pharmaceuticals Announces CHMP Positive Opinion For AbbVie's VIEKIRAX + EXVIERA Without Ribavirin For The Treatment Of Chronic Hepatitis C In Genotype 1b Patients With Compensated Cirrhosis

2016-03-02 03:39:36| drugdiscoveryonline Home Page

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced recently that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-PughA)

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Are you at risk for viral hepatitis? This quiz could help save your life

2016-02-26 16:49:00| Biotech - Topix.net

If you answered "yes" to any of these questions, you could be at risk for viral hepatitis. The Centers for Disease Control and Prevention developed a five-minute quiz to help people find out if they should be tested or vaccinated for viral hepatitis.

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FDA OKs Merck hepatitis C drug, adding to patient choices

2016-01-29 02:48:54| Biotech - Topix.net

Patients with hepatitis C have yet another advanced treatment option, as the Food and Drug Administration on Thursday approved a new once-a-day pill developed by drugmaker Merck. The FDA said Merck can begin marketing Zepatier for patients with two of the subtypes the liver-destroying virus, types 1 and 4. The combination pill includes the medications elbasvir and grazoprevir, which attack the virus in two different ways.

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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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Massachusetts is investigating high cost of hepatitis C drug

2016-01-27 20:23:56| Biotech - Topix.net

The Massachusetts attorney general's office is investigating whether the makers of a breakthrough treatment for hepatitis C are violating state law by pricing the drug too high. Attorney General Maura Healey on Wednesday released a letter sent to the chief executive of California-based Gilead Sciences Inc. In it, Healey said her office was examining whether the pricing constituted an unfair trade practice.

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