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Bristol-Myers gains FDA breakthrough track for HCV drug approval
tkim@idsociety.org
Posted: Thursday, April 25, 2013 2:00 PM
Joined: 2/20/2013
Posts: 39


"Bristol-Myers Squibb just gained an inside regulatory track in the frantic race to get new interferon-free hepatitis C drugs to the FDA. The big biotech reported in its quarterly statement that the agency has provided the coveted "breakthrough" status for a combination of daclatasvir with two other direct-acting antivirals, asunaprevir, an NS3 protease inhibitor and BMS-791325, an NS5B non-nucleoside polymerase inhibitor."

To read more: http://www.fiercebiotech.com/story/bristol-myers-gains-fdas-breakthrough-track-race-hep-c-drug-approval/2013-04-25#ixzz2RV0dZP00