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April 7, 2014
08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
Bristol-Myers Squibb Company has submitted new drug applications with the U.S. Food and Drug Administration for the investigational products daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C. The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing. These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.
News For BMY From The Last 14 Days
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September 17, 2014
07:43 EDTBMYBofA/Merrill to hold a conference
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September 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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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).

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