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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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March 26, 2015
07:30 EDTBMYDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
March 24, 2015
08:02 EDTBMYBristol-Myers acquires exclusive license from Novo Nordisk for research program
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March 20, 2015
07:55 EDTBMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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