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February 10, 2014
08:27 EDTMDCOFDA team leader recommends not approving cangrelor
Thomas A. Marciniak, M.D., a Medical Team Leader for the FDA, stated in briefing documents ahead of the February 12 panel meeting, "I recommend not approving cangrelor at this time for the PCI indication. I recommend not approving cangrelor until another trial succeeds in correcting the flaws that I have documented in this review and in my parallel review on the ethicalness of the cangrelor development program." Cangrelor is developed by The Medicines Co. and is an intravenously administered P2Y12 platelet inhibitor studied in three clinical outcomes trial in patients undergoing percutaneous coronary intervention. Shares of The Medicines Co. are down 12% to $29.99 after the documents were posted on the FDA's website. Reference Link
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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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