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News Breaks
February 4, 2013
13:25 EDTMDCO, MDCO, MDCOLeerink's biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz, along with MEDACorp Specialist Cahrles Whitcomb, MD, discuss the prospects for The Medicines Co's Cangrelor in Percutaneous Coronary Intervention (PCI)/Acute Coronary Syndrome (ACS) on an Analyst/Industry conference call to be held on February 7 at 2 pm.
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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.

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