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News Breaks
December 30, 2013
07:31 EDTCBSTCubist announces FDA acceptance of tedizolid NDA with priority review
Cubist Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Application for its investigational antibiotic tedizolid phosphate -- TR-701 -- with Priority Review. The FDA has assigned a Prescription Drug User Fee Act action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections. The NDA submission is based on positive data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency. During the first half of 2014 Cubist expects to submit a Marketing Authorization Application for tedizolid to the EMA in the ABSSSI indication. Cubist is also expecting to submit a New Drug Submission to Health Canada in the same timeframe.
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April 18, 2014
13:32 EDTCBSTCubist announces voluntarily recalling one Cubicin lot
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April 8, 2014
11:03 EDTCBSTPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.

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