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News Breaks
February 27, 2014
08:50 EDTMDCOThe Medicines Co. announces EMA accepts MAA for oritavancin
The Medicines Company announced that the European Medicines Agency has accepted for review a marketing authorization application for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus, administered as a single dose. The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients with 405 of the patients suffering from a cSSTI with a documented MRSA infection. The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration in the U.S.
News For MDCO From The Last 14 Days
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April 20, 2015
07:07 EDTMDCOThe Medicines Co. reports FDA approves new formulation of MINOCIN
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07:02 EDTMDCOEagle Pharmaceuticals price target raised to $75 from $55 at Piper Jaffray
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April 15, 2015
17:49 EDTMDCOThe Medicines Co. up 7% after FDA panel backs approval of cangrelor
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17:18 EDTMDCOThe Medicines Co. confirms FDA Advisory Committee backs approval of cangrelor
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15:37 EDTMDCOFDA panel votes in favor of approval for cangrelor
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07:57 EDTMDCOThe FDA Cardiovascular & Renal Drugs Advisory Committee to hold a meeting
The Committee discusses The Medicines Company's New Drug Application (NDA) 204958 Cangrelor injection for proposed indication of reduction of thrombotic cardiovascular events at a meeting being held at FDA Silver Spring, Maryland offices on April 15 at 8 am. Webcast Link
07:01 EDTMDCOThe Medicines Co. stock trading halted today
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April 13, 2015
11:13 EDTMDCOFDA panel briefing docs look positive for Medicines Co., says Leerink
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10:15 EDTMDCOHigh option volume stocks
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