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Stock Market & Financial Investment News

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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November 20, 2014
10:02 EDTMDCOOn The Fly: Analyst Upgrade Summary
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07:41 EDTMDCOThe Medicines Co. upgraded at Credit Suisse
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06:06 EDTMDCOThe Medicines Co. upgraded to Outperform from Neutral at Credit Suisse
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November 16, 2014
13:41 EDTMDCOThe Medicines Co. presents findings from MDCO-216 study
The Medicines Company presented findings from a new Phase 1 study showing that a single infusion of MDCO-216, an investigational lipid-modifying agent, in both healthy and CAD patients, modified key lipid parameters including ApoA-1, phospholipids, HDL, pre-beta 1 HDL and Apo E, markedly increased ABCA1 mediated efflux, a potential marker of reverse cholesterol transport and was well tolerated. The study was presented today as part of a poster session at The American Heart Association’s Annual Scientific Sessions in Chicago. Clinical findings have shown that human carriers of the ApoA-1 Milano variant have a reduced incidence of cardiovascular disease. MDCO-216, currently under development by The Medicines Company, is a complex of recombinant human Apo A1 with phospholipids to emulate an HDL particle. MDCO-216 has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport, and its potential impact on reducing cardiovascular events in acute coronary syndrome, ACS, patients. “This study provides a signal that MDCO-216 is able to modulate lipid parameters consistent with those humans with the ApoA-1 variant, had an important effect on markers of reverse cholesterol transport such as pre-beta1 HDL and ABCA1 mediated efflux, and importantly was well-tolerated,” commented David Kallend, MBBS, Vice President and Global Medical Director for the Lipid Programs at The Medicine Company. “These findings support the continued development of MDCO-216 as a potential treatment to help address a currently unmet need in coronary artery disease patients."

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