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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.
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December 18, 2014
07:01 EDTMDCOThe Medicines Co., SciClone establish strategic partnership
The Medicines Company (MDCO) and SciClone Pharmaceuticals (SCLN) announced the establishment of a strategic partnership for two cardiovascular products in China. The partnership includes an agreement granting SciClone a license and the exclusive rights in China to promote two products of The Medicines Company: ANGIOMAX for Injection, an anticoagulant indicated in patients undergoing percutaneous coronary intervention with provisional use of glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI. A Phase 3 registration trial was completed in China and is currently under review by the China Food and Drug Administration for marketing approval. CLEVIPREX Injectable Emulsion, a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or desirable. The clinical trial application for China was filed in 2013. Under the terms of the agreement, SciClone will be responsible for all aspects of commercialization, including pre- and post-launch activities, for both products in the China market excluding Hong Kong and Macau. SciClone has also agreed to assist in the China registration process for both products. Financial terms of the agreement, in addition to net sales royalties payable to The Medicines Company, include the following additional payments to The Medicines Company: an upfront payment; a product support services fee; and regulatory/commercial success milestone payments of up to an aggregate of $50.5M.
December 11, 2014
08:02 EDTMDCOAlnylam, The Medicines Co. announce initiation of Phase 1 ALN-PCSsc trial
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December 8, 2014
12:25 EDTMDCOAntibiotic makers rise after Merck agrees to buy Cubist
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10:11 EDTMDCOHigh option volume stocks
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