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News Breaks
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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May 28, 2015
09:24 EDTMDCOJefferies sees Pharma M&A continuing, lists 22 possible targets
Jefferies analyst David Steinberg believes the M&A wave in the Pharmaceuticals space that began in 2005 can continue as the key drivers remain largely intact. In a note titled "Who is Next? The Feeding Frenzy in Specialty Pharmaceuticals," Steinberg sees deals continuing amid cheap debt, the push for lower corporate taxes and investors rewarding many acquirers for their transactions. He points out there are now around 100 publicly traded Specialty Pharmaceutical companies following the recent life sciences IPO boom. Potential takeover targets, according to Steinberg, include Valeant (VRX), Shire (SHPG), Perrigo (PRGO), Zoetis (ZTS), Mallinckrodt (MNK), Jazz Pharmaceuticals (JAZZ), United Therapeutics (UTHR), Pacira (PCRX), Indivior, Insys Therapeutics (INSY), The Medicines Co. (MDCO), Depomed (DEPO), Spectrum (SPPI), KYTHERA (KYTH), Revance (RVNC), XenoPort (XNPT), Mylan (MYL), Akorn (AKRX), Impax (IPXL), Amphastar Pharmaceuticals (AMPH), Anacor (ANAC) and BioDelivery Sciences (BDSI).
May 26, 2015
10:39 EDTMDCOThe Medicines Co. says data show remodeling effect of MDCO-216 on HDL
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May 20, 2015
06:55 EDTMDCOEagle Pharmaceuticals submits NDA for ready-to-use bivalirudin to FDA
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