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  • Merck Throws a Wrench in Drug Pricing

    Volume may help Merck make up what it loses on price. AbbVie and Gilead's drugs are priced so high that many governments and insurers will only pay for them for patients that have severe liver scarring, given HCV's slow progression. Zepatier is priced at a point that could make it affordable to treat a much larger population at earlier stages of the disease.

    01 February 2016 | Bloomberg
  • Zepatier for hepatitis C approved in Canada

    On January 19, 2016, Health Canada licensed the use of Zepatier for the treatment of certain strains of hepatitis C virus (HCV) in adults. Canada is the first country to approve Zepatier. This drug is made by the pharmaceutical company Merck and should be available for order by drug stores early in February 2016.

    01 February 2016 | CATIE
  • Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults

    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. ZEPATIER (pronounced ZEP-ah-teer) is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg).

    29 January 2016 | Merck press release
  • The 2016 Hepatitis C Drug Approval Outlook

    Here’s what’s in store this year for new hepatitis C therapies, as well as approvals for new uses of existing treatments.

    18 January 2016 | Poz
  • AbbVie Initiates Enrollment of Six Global Phase 3 Clinical Studies for Once-Daily, Pan-Genotypic Hepatitis C Regimen

    AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection. The new investigational regimen evaluates treatment durations of 12 weeks and as short as eight weeks in genotype 1 patients.

    11 January 2016 | AbbVie press release
  • Mylan Launches Generic Harvoni® (Ledipasvir/Sofosbuvir) Under the Brand Name MyHep LVIR™ in India

    Mylan N.V. (NASDAQ, TASE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched generic Harvoni® (Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name MyHep LVIR™ in India.

    08 January 2016 | Mylan press release
  • Inside the hepatitis C virus is a promising antiviral

    A peptide derived from the hepatitis C virus (HCV) kills a broad range of viruses while leaving host cells unharmed by discriminating between the molecular make-up of their membranes, reveals a study published January 5 in the Biophysical Journal. The peptide was potent against a range of cholesterol-containing viruses, including West Nile, dengue, measles, and HIV.

    06 January 2016 | Medical Xpress
  • Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection

    Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

    05 January 2016 | Gilead press release
  • AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK®

    AbbVie today announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets).

    02 December 2015 | AbbVie press release
  • Study suggests unprecedented 3-week hepatitis C cure

    Yet another stunning victory in the drug battle against the liver-damaging hepatitis C virus (HCV) may be in the offing: A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks.

    02 November 2015 | Science
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