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New rival to Gilead hepatitis C drug approved

2014-12-20 07:32:32| Biotech - Topix.net

Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois.

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Gilead faces lawsuit over hepatitis C drug pricing

2014-12-11 01:47:59| Biotech - Topix.net

" Philadelphia's Transportation Authority has filed a lawsuit against Gilead Sciences Inc. over the pricing of its hepatitis C drug. Sovaldi is a highly effective pill treatment for the most common form of hepatitis C without the injections and unpleasant side effects of earlier treatments.

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Bristol-Myers: FDA blocks hepatitis C drug for...

2014-11-26 20:55:53| Biotech - Topix.net

U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir. The company said Wednesday that data it submitted to the Food and Drug Administration to win approval of daclatasvir focused on that drug's use with asunaprevir.

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Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Nave and Difficult-to-Cure Patients

2014-11-11 14:00:00| Merck.com - Research & Development News

Dateline City: BOSTON Final Results from the C-WORTHy Study (Parts A and B) Presented at The Liver Meeting and Published in The Lancet First Wave of Phase 3 Development Program for Grazoprevir/Elbasvir is Fully Enrolled; Merck Plans to Submit New Drug Application in 2015 BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from a multi-arm Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742, the companys investigational NS3/4A protease inhibitor and NS5A inhibitor, respectively) with or without ribavirin (RBV) in treatment-nave and previously-treated (with peg-interferon/ribavirin [PR]) patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection -- the C-WORTHy study (Parts A and B). Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558Sarra Herzog, 201-669-6570orInvestors:Joe Romanelli, 908-423-5185Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Interim Data from Proof-of-Concept Study of Mercks Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting

2014-11-10 00:53:00| Merck.com - Research & Development News

Dateline City: BOSTON Merck Plans to Initiate Phase 2 C-CREST Program to Evaluate Mercks Triple Combination of Grazoprevir/Elbasvir with MK-3682 (formerly IDX21437), a Novel Nucleotide Inhibitor, in Q1 2015 BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the C-SWIFT study exploring the potential of a candidate triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir (MK-5172/MK-8742, MK-5172A), the companys investigational NS3/4A protease inhibitor and NS5A inhibitor, in combination with sofosbuvir, a nucleotide (NS5B) inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orSarra Herzog, 201-669-6570orInvestor:Joe Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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