New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 27, 2014
08:50 EDTMDCOThe Medicines Co. announces EMA accepts MAA for oritavancin
The Medicines Company announced that the European Medicines Agency has accepted for review a marketing authorization application for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus, administered as a single dose. The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients with 405 of the patients suffering from a cSSTI with a documented MRSA infection. The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration in the U.S.
News For MDCO From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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.
September 25, 2015
09:01 EDTMDCOThe Medicines Co. receives CHMP positive opinion for Ionsys
Subscribe for More Information
September 22, 2015
07:53 EDTMDCOThe Medicines Co. management to meet with Leerink
Meetings to be held in Boston on September 24-25 hosted by Leerink.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use