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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
News For MDCO From The Last 14 Days
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October 9, 2015
08:30 EDTMDCOBioNJ to hold a summit
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October 6, 2015
17:16 EDTMDCOThe Medicines Co., SymBio Pharmaceuticals enter strategic partnership in Japan
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October 5, 2015
07:31 EDTMDCOThe Medicines Co. ALN-PCSsc 'a potential game changer,' says RBC Capital
After examining surveys and speaking with experts, RBC Capital says that the uptake of The Medicines Co's ALN-PCSsc treatment has been strong among anti-PCSK9 patients, reaching 20%-30%. The firm estimates that the company could conservatively generate $9B-$18B in revenue from the drug. It believes that the product is "a potential game changer and valuation driver" for the company. RBC keeps a $46 price target and Outperform rating on the shares.
October 1, 2015
07:05 EDTMDCOMedicines Company says BARDA exercises option on Carbavance pact
The Medicines Company announced that Rempex Pharmaceuticals, a wholly owned subsidiary, has been awarded the next option on a contract by the Biomedical Advanced Research and Development Authority, or BARDA, to support the development of CARBAVANCE. CARBAVANCE is the combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor that is targeted for treatment of multi-drug resistant gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae. The cost-share contract with BARDA was initiated in 2014 and extends over 5 years. The award of this third option brings the total commitment from BARDA to $53.8M. If all options are exercised in the contract, it would bring the total value of the award to approximately $90M.

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