TMC Looks To Add cSSSI Drug, Antibiotic Capabilities With Targanta Offer
This article was originally published in The Pink Sheet Daily
Executive SummaryProposed merger would see The Medicines Company take over development of oritavancin, stalled at FDA due to “complete response” letter.
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FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.