TMC Looks To Add cSSSI Drug, Antibiotic Capabilities With Targanta Offer
This article was originally published in The Pink Sheet Daily
Executive Summary
Proposed merger would see The Medicines Company take over development of oritavancin, stalled at FDA due to “complete response” letter.You may also be interested in...
With GAIN In Place, Antibiotic Improvements Depend On FDA Implementation
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.
The Medicines Co. Pulls European Application For Oritavancin
Specialty pharma plans to investigate antibiotic as single-dose, 1,200 mg therapy after FDA and EMEA turned down proposed 200 mg, multi-day dosing.
The Medicines Co. Pulls European Application For Oritavancin
Specialty pharma plans to investigate antibiotic as single-dose, 1,200 mg therapy after FDA and EMEA turned down proposed 200 mg, multi-day dosing.
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