Clinical Trials - March 5, 2014
Medivir presents positive results from simeprevir study
Data from the study demonstrate that sustained virologic response 12 weeks after the end of treatment (SVR12) was reached in 75 to 85 percent of treatment-naïve patients and 65 to 95 percent of prior null responders with HCV genotype 1b after 12 or 24 weeks of treatment. “We are pleased to report on the successfully […]
Clinical Trials - January 17, 2014
Interim results from a phase II all-oral combination study of Simeprevir and Samatasvir
Medivir announces that Idenix Pharmaceuticals today released interim data from the ongoing phase II HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor, and simeprevir , a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir, and ribavirin. The combination regimen of the […]
Drug Development Pharma - November 25, 2013
US approval of Simeprevir
Medivir has received US approval of its Simeprevir for the treatmeant of hepatitis C. On Friday 22 Medivir and Janssen’s drug candidate Simeprevir was approved for the US market by the Food and Drug Administration (FDA). The product will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with […]
Drug Development Pharma - November 21, 2013
Medivir’s Simeprivir approved in Canada
Medivir AB has announced that Health Canada has approved as a new treatment for hepatitis C. Simeprevir will be approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment‑naïve or who have failed previous interferon therapy […]
Clinical Trials - October 25, 2013
Medivir announce data from phase III studies
The Swedish company has announced preliminary data from two phase III studies conducted by Janssen R&D Ireland evaluating simeprevir in genotype 4 chronic hepatitis C in adult patients with compensated liver disease, and in genotype 1 hepatitis C and HIV-1 co-infected adult patients. “Based on these encouraging data with the high cure rates seen in […]
Pharma Business - September 27, 2013
Medivir’s Simeprevir has been approved in Japan
Medivir today reports that that simeprevir has been approved for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. “The approval in Japan is a very important step in providing patients with new treatment options. It is the first approval based on the series of global filings that our partner initiated during 2013. […]
