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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
News For MDCO From The Last 14 Days
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October 22, 2014
09:45 EDTMDCOThe Medicines Co. says 'as open as can possibly be' to potential takeover
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09:21 EDTMDCOThe Medicines Co. lowers 2014 revenue outlook to $720M-$735M
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07:11 EDTMDCOMedicines Co. says Angiomax, Angiox revenue up 5% in first nine months
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07:06 EDTMDCOThe Medicines Co. reports Q3 EPS (26c) , consensus (12c)
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October 20, 2014
09:48 EDTMDCOBrdiger Management reports 5.1% passive stake in The Medicines Co.
October 13, 2014
07:25 EDTMDCOEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
October 10, 2014
07:14 EDTMDCOThe Medicines Co's Q3 Angiomax estimate lowered at Credit Suisse
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October 9, 2014
16:57 EDTMDCOThe Medicines Co. announces journal publication of SOLO II phase 3 trial
The Medicines Company announced the publication of the results from the SOLO II phase 3 clinical trial of ORBACTIV, or oritavancin, for injection in the journal Clinical Infectious Diseases. ORBACTIV, is the first and only single dose intravenous antibiotic approved by FDA for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, caused or suspected to be caused by susceptible isolates of designated Gram-positive pathogens. The publication reported that a single, once only, 1200 mg intravenous dose of ORBACTIVTM was non-inferior to twice-daily intravenous dosing of vancomycin given for 7 to 10 days in patients with ABSSSI caused or suspected to be caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. A single 1200 mg IV dose of ORBACTIV results in efficacy in ABSSSIs that is comparable and statistically non-inferior to vancomycin administered intravenously for 7-10 days. ORBACTIV had a safety profile comparable to vancomycin when monitored for up to 60 days following a single dose, with similar intensity, onset and duration of AEs.

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