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August 7, 2014
17:56 EDTMDCOThe Medicines Co. could have 25% upside, Barron's says
FDA approval of The Medicines Co. skin infection drug Orbactiv should give shares a boost and although the stock is not cheap, it is cheap enough to buy, Barron's argues in its Barron's Take column. The company's pipeline should bolster its earnings, the paper adds. Reference Link
News For MDCO From The Last 14 Days
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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.
November 11, 2015
10:46 EDTMDCOAlnylam and The Medicines Co. reports trial results with ALN-PCSsc
Alnylam (ALNY) and The Medicines Company (MDCO) reported results from their ongoing Phase 1 clinical trial with ALN-PCSsc in an oral presentation at the American Heart Association Scientific Sessions 2015. ALN-PCSsc is an investigational RNAi therapeutic targeting PCSK9 - a genetically validated protein regulator of LDL receptor metabolism - being developed for the treatment of hypercholesterolemia. As reported previously, subcutaneous administration of ALN-PCSsc resulted in an up to 83% lowering of LDL-C, with an up to 64 +/- 5 percent mean maximum reduction, comparable to published results for anti-PCSK9 MAbs. In new results, the effects of ALN-PCSsc were found to be highly durable, with clinically significant and clamped reductions in LDL-C, supportive of a potential bi-annual subcutaneous dose regimen. Specifically, an up to 53 percent maximal and 47% least squares mean reduction in LDL-C was achieved at day 180 after just a single, low volume injection. In addition, ALN-PCSsc was shown to reduce a number of atherogenic lipids, including lipoprotein - or "Lp" - and total cholesterol, which are associated with increased risk of cardiovascular disease. ALN-PCSsc was generally well tolerated with no clinically significant drug-related adverse events. The development leadership of ALN-PCSsc has now transferred from Alnylam to The Medicines Company, who expects to initiate the ORION-1 Phase 2 study by the end of 2015.

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