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August 7, 2014
05:11 EDTMDCOThe Medicines Co. Orbactiv approved by FDA
The Medicines Company announced that the FDA has approved Orbactiv for injection for the treatment of adults with acute bacterial skin and skin structure infections, or ABSSSI, caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus. Orbactiv is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the Orbactiv treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.
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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.
November 13, 2015
14:52 EDTMDCOFederal Circuit overturns District Court decision on Angiomax patents
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13:57 EDTMDCOAppeals court vacates decision invalidating Medicines Co. Angiomax patents
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13:38 EDTMDCOThe Medicines Co. jumps 9% following reports of court decision
Shares of The Medicines Co. jumped after reports surfaced that an appeals court vacated the decision invalidating Angiomax patents.

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