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News Breaks
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.
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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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