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Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

2015-05-28 22:30:00| 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, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. Language: English Contact: MerckMedia:Doris Li, 908-246-5701orSarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Woman sues Anthem Blue Cross for refusing to cover hepatitis C drug

2015-05-19 09:30:23| Biotech - Topix.net

A West Hollywood woman sued insurer Anthem Blue Cross for refusing to cover the cost of an expensive drug that she says would cure her hepatitis C infection. Shima Andre said in the lawsuit that Anthem has refused to pay the estimated $99,000 it would cost to be treated with the controversial drug Harvoni, which has been shown to destroy the deadly virus in most patients.

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Expensive Hepatitis C Cure Raises Tough Questions

2015-05-18 13:45:13| Biotech - Topix.net

In some quarters, it is known as the Sovaldi Squeeze: on one side, the urgent need to treat a disease, and on the other, the budget-crippling cost of doing so. Connecticut, like other states, is caught in the middle.

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Gilead lifted by $3.6B 1Q sales of newest hepatitis C pill

2015-05-01 02:36:04| Biotech - Topix.net

Gilead Sciences raked in $3.6 billion from sales of its newest hepatitis C pill, lifting the drugmaker's results past Wall Street expectations. Meanwhile, sales of Gilead's previous hepatitis C drug, Sovaldi, dropped 57 percent to $972 million.

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Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver CongressTM 2015

2015-04-25 15:00:00| Merck.com - Corporate News

Dateline City: VIENNA Results of C-SALVAGE Study Showed High Sustained Virologic Response Rates in Patients Who Failed Prior Combination Therapy with Certain Direct Acting Antiviral (DAA) Agents Results of C-SWIFT Study Provide Proof-of-Concept for Shorter Than Twelve Weeks Duration of Treatment with Triple-DAA Regimen in Patients with Chronic Hepatitis C Virus (HCV) Genotypes 1 and 3 Infection VIENNA April 25, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from two Phase 2 clinical trials evaluating the safety and efficacy of the companys investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg)[1] in adult patients with chronic hepatitis C virus (HCV) infection. Language: English read more

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