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News Breaks
June 27, 2014
07:01 EDTBMYBristol-Myers receives positive CHMP opinion for Daklinza for treatment of HCV
Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japanís Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act of November 30.
News For BMY From The Last 14 Days
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September 5, 2014
16:45 EDTBMYMarket ends week little changed after mixed economic data
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11:17 EDTBMYBristol-Myers files patent infringement suit against Merck
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September 4, 2014
08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).
September 2, 2014
07:12 EDTBMYCredit Suisse names its Top U.S. Pharmaceutical picks for 2H
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07:10 EDTBMYAlder Biopharmaceuticals regains worldwide rights to clazakizumab
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