Key Developments: Medicines Co (MDCO.O)

MDCO.O on Nasdaq

19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Medicines Co and SciClone Pharmaceuticals establish strategic partnership for two cardiovascular products in China
Thursday, 18 Dec 2014 07:00am EST 

Medicines Co and SciClone Pharmaceuticals:Announced the establishment of a strategic partnership for two cardiovascular products in China.Says SciClone will be responsible for all aspects of commercialization, including pre- and post-launch activities, for both products in the China market (excluding Hong Kong and Macau).Says SciClone has also agreed to assist in the China registration process for both products.Says financial terms of the agreement, in addition to net sales royalties payable to Medicines Co, include additional payments to Medicines Co: an upfront payment; a product support services fee; and regulatory/commercial success milestone payments of up to an aggregate of $50.5 mln.  Full Article

Alnylam Pharmaceuticals and Medicines Co announce initiation of Phase 1 Clinical Trial for ALN-PCSsc
Thursday, 11 Dec 2014 08:00am EST 

Alnylam Pharmaceuticals Inc and Medicines Co:Has initiated a Phase 1 clinical trial with ALN-PCSsc, an investigational agent for the treatment of hypercholesterolemia.As previously guided, the companies expect to report initial clinical data from the trial in mid-2015.  Full Article

The Medicines Company presents new phase 1 data showing investigational agent MDCO-216 modified key lipid parameters
Friday, 14 Nov 2014 10:00pm EST 

The Medicines Company:Says that it presented findings from a new Phase 1 study showing that a single infusion of MDCO-216, an investigational lipid-modifying agent, in both healthy and CAD patients.Says modified key lipid parameters including ApoA-1, phospholipids, HDL, pre-beta 1 HDL and Apo E, markedly increased ABCA1 mediated efflux, a potential marker of reverse cholesterol transport and was well tolerated.Says the study was presented as part of a poster session at The American Heart Association's Annual Scientific Sessions in Chicago.Says Clinical findings have shown that human carriers of the ApoA-1 Milano variant have a reduced incidence of cardiovascular disease.Says MDCO-216, currently under development by The Medicines company, is a complex of recombinant human Apo A1 with phospholipids to emulate an HDL particle.Says MDCO-216 has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport, and its potential impact on reducing cardiovascular events in acute coronary syndrome (ACS) patients.  Full Article

The Medicines Co wins favorable judgment in Angiomax (Bivalirudin) patent litigation
Monday, 27 Oct 2014 08:04pm EDT 

The Medicines Co:Says that the U.S. District Court for Northern District of Illinois in The Medicines Co v. Mylan, Inc. entered judgment in favor of The Medicines Company on all issues concerning U.S. Patent No. 7,582,727 (the 727 patent).Following June 2014 trial, Judge Amy St. Eve found all of asserted claims (patent claims 1-3, 7-10, and 17) are infringed by Mylan's Abbreviated New Drug Application (ANDA).Same claims were also found to be valid and enforceable.  Full Article

Medicines Co lowers FY 2014 revenue guidance - Conference Call
Wednesday, 22 Oct 2014 08:30am EDT 

Medicines Co:Revises FY 2014 net revenue to $720 to $735 million.Says it is a reduction of $25 million and is driven by the decline in ex-US sales of Angiox.FY 2014 revenue of $730 million - Thomson Reuters I/B/E/S.  Full Article

FDA approves Medicines Co's ORBACTIV for use in acute bacterial skin and skin structure infections
Wednesday, 6 Aug 2014 08:31pm EDT 

Medicines Co:Says that the U.S. Food and Drug Administration has approved ORBACTIV (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus.Says ORBACTIV is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration.Says Once fully infused over three hours, the ORBACTIV treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.  Full Article

Medicines Co receives market authorization renewal for Angiox (Bivalirudin) from the European Medicines Agency and the European Commission
Monday, 7 Jul 2014 09:00am EDT 

Medicines Co:Announces that the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), and the European Commission have granted market authorization renewal for Angiox.Following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan.Says the CHMP recommendation for the renewal of the marketing authorization for Angiox reconfirms its favorable risk-benefit profile.Angiox is a direct thrombin inhibitor and is indicated in Europe as an anticoagulant in adult patients undergoing percutaneous coronary intervention.  Full Article

The Medicines announces ORBACTIVTM Phase 3 Trial Results
Thursday, 5 Jun 2014 06:00am EDT 

The Medicines Co:Publishes results from SOLO I Phase 3 clinical trial of ORBACTIV (oritavancin), an investigational intravenous antibiotic treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), in New England Journal of Medicine.Publication reported that a single 1200 mg intravenous dose of ORBACTIV 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.  Full Article

The Medicines Co receives complete response letter from FDA requesting additional information for new drug application for its antiplatelet agent cangrelor
Wednesday, 30 Apr 2014 10:00pm EDT 

The Medicines Co:Announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company's new drug application for its investigational intravenous antiplatelet agent cangrelor.For the PCI indication, the Agency stated that the application cannot be approved at the present time.The agency suggested that the company perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials.The Agency provided additional comments for the company to address, stating that the comments are not currently approvability issues, but could affect labeling.  Full Article

Medicines Co to acquire Tenaxis
Wednesday, 23 Apr 2014 07:00am EDT 

The Medicines Co:Parties agreement for Medicines Co to acquire Tenaxis.Medicines Cowill pay $58 mln upfront on closing of deal.Medicines Co will also pay milestone payments of up to $112 mln contingent upon achieving certain commercial milestones.  Full Article

Medicines Co wins patent infringement suit against Mylan

Oct 27 - A U.S. court ruled Mylan Inc infringed the Medicines Co's patent on its blood-clot-inhibitor Angiomax, according to a court filing on Monday.

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