Saturday, January 21, 2017

CTP-656 Receives Orphan Drug Designation

Concert Pharmaceuticals received Orphan Drug Designation from the FDA in press release here, Orphan Drug Designation for CTP-656 for the Treatment of Cystic Fibrosis.  The significance of this, is that CTP-656 could receive up to seven years of marketing exclusivity, and even more importantly, gets FDA assistance in clinical trial design.  Orphan Drug Designation is given to a disease or condition that affects less than 200,000 people in the U.S.  Thank you for reading.
 

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