News & Media

Press release Regulatory
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated

Stockholm, Sweden—Medivir AB (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients...

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Press release Regulatory
Simeprevir is now available for Hepatitis C patients in Japan, USA and Canada

Stockholm, Sweden—Medivir AB (OMX: MVIR) Based on the recent approvals in Japan, Canada and USA, simeprevir is now available in all...

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Press release Regulatory
HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated

Stockholm, Sweden—Medivir AB (OMX: MVIR), announces that IDENIX has initiated a phase II clinical trial (HELIX-2) evaluating an all-oral, direct-acting antiviral...

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Press release Regulatory
Simeprevir has been approved in the USA as a new treatment for hepatitis C

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that U.S. Food and Drug Administration (FDA) has approved simeprevir for the...

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Press release Regulatory
Interim Report, 1 January – 30 September 2013*

Q3 2013 (July-September) Remaining Group operations, excluding Cross Pharma Net turnover totalled SEK 80.2 million (SEK 36.6 m), SEK 43.6 million...

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Press release Regulatory
Simeprevir has been approved in Canada as a new treatment for hepatitis C

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C...

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Press release Regulatory
Results from the COSMOS study with Simeprevir and Sofosbuvir in cirrhotic and non-cirrhotic HCV genotype 1 patients presented at AASLD

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced data from the interferon-free COSMOS study demonstrating safety and efficacy of the...

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Press release Regulatory
Medivir announces that new Simeprevir data will be presented at the AASLD meeting

Stockholm, Sweden — Medivir AB (OMX: MVIR) announces that new data will be presented on the investigational protease inhibitor simeprevir (TMC435)...

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Press release Regulatory
FDA Advisory Committee recommends approval of Simeprevir for combination treatment of genotype 1 chronic hepatitis C in adult patients

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug...

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Press release Regulatory
The regulatory process for Simeprevir in the U.S.

Stockholm, Sweden — Medivir AB (OMX: MVIR) In March 2013, Medivir’s partner Janssen Pharmaceuticals, Inc. (Janssen) filed a new drug application...

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Press release Regulatory
Medivir announces data from two phase III studies with Simeprevir in hepatitis C subpopulations – HCV/HIV co-infected and genotype 4 infected patients

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced preliminary data from two phase III studies conducted by Janssen R&D Ireland...

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Press release Regulatory
Medivir Nomination Committee appointed

Stockholm, Sweden — Medivir AB (OMX: MVIR) announced that its Nomination Committee has been appointed. According to an AGM resolution, the...

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