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February 5, 2014
08:25 EDTMDCOThe Medicines Co. subsidiary awarded contract worth up to $90M
The Medicines Company announced that Rempex Pharmaceuticals, a wholly owned subsidiary, has been awarded a contract by the Biomedical Advanced Research and Development Authority, or BARDA, worth up to $90M to support the development of Carbavance. Carbavance is a combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor for treatment of multi-drug resistant gram-negative infections. The BARDA contract is a cost-sharing arrangement that includes non-clinical development activities, clinical studies, manufacturing, and associated regulatory activities designed to gain U.S. approval of Carbavance for treatment of serious gram-negative infections. Studies are also planned to assess the potential usefulness of Carbavance for treatment of certain gram-negative bioterrorism agents. The contract includes an initial commitment of $19.8M and subsequent option periods over 5 years that, if completed, would bring the total value of the award to approximately $90M.
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November 30, 2015
10:15 EDTMDCOThe Medicines Co. management to meet with JPMorgan
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November 20, 2015
12:02 EDTMDCOThe Medicines Co. receives EC approval for IONSYS
The Medicines Company announced that the European Commission has granted marketing authorization for IONSYS(40 micrograms per dose transdermal system), with active ingredient fentanyl, for the management of acute moderate-to-severe, post-operative pain in adult patients for use in the hospital. IONSYS will be the only needle-free, patient-controlled, pre-programmed iontophoretic transdermal delivery system for use in adult patients requiring opioid analgesia in EU hospital settings. The marketing authorization follows the issuance of a positive opinion in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is now valid in the 31 countries of the European Economic Area, which includes all 28 European Union Member States, plus Norway, Iceland and Liechtenstein. A supplemental new drug application for IONSYS was approved by the U.S. FDA in April 2015 with an approved IONSYS Risk Evaluation Mitigation Strategy program. The product is commercially available in the U.S. as of July 2015.

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