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December 6, 2012
16:02 EDTCBSTFDA grants QIDP designation to two Cubist Phase 3 antibiotic candidates
Cubist Pharmaceuticals announced that the FDA has designated two of the company's Phase 3 antibiotic candidates, CXA-201 and CB-315, as Qualified Infectious Disease Products, or QIDP. The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa. The FDA's QIDP designation applies to CXA-201's treatment of complicated intra-abdominal infections. CB-315 is currently being investigated in Phase 3 trials as an oral therapy for Clostridium difficile-associated diarrhea, or CDAD.
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July 14, 2014
05:51 EDTCBSTAchaogen appoints Dr. Ian Friedland as Chief Medical Officer
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