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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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August 22, 2014
07:31 EDTCBSTCubist annouces EMA acceptance of ceftolozane, tazobactam MAA
Cubist announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane, tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission expected during 1H15. The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane, tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes.
August 18, 2014
11:41 EDTCBSTCubist rises after report sparks takeover interest speculation
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09:43 EDTCBSTCubist may receive takeover interest, Bloomberg reports
Cubist Pharmaceuticals' (CBST) focus on bacterial infections could attract takeover interest, Bloomberg reports in its Real M&A column. Reference Link

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