Key Developments: Medicines Co (MDCO.O)

MDCO.O on Nasdaq

24 Oct 2014
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Latest Key Developments (Source: Significant Developments)

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

Pomerantz LLP files class action against Medicines Co
Friday, 18 Apr 2014 01:28pm EDT 

Medicines Co:Pomerantz LLP files class action lawsuit against Medicines Co and certain of its officers.The class action, filed in United States District Court, District of New Jersey.This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.  Full Article

FDA accepts filing of Medicines Co's US biologic license application for fibrocaps hemostatic agent
Thursday, 3 Apr 2014 07:00am EDT 

Medicines Co:Says that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin.  Full Article

Medicines Co updates on Angiomax patent litigation
Monday, 31 Mar 2014 10:00pm EDT 

Medicines Co:Says on March 31, 2014, Judge Andrews in the U.S. District Court of Delaware issued his Trial Opinion in The Medicines company vs. Hospira, Inc.The case involves Hospira's Abbreviated New Drug Applications seeking approval to commercially manufacture, use or sell a generic version of The Medicines company's Angiomax bivalirudin drug product before the expiration of the patents covering this product.With respect to patent validity, the Court held that the two patents in the case, U.S. Patent Nos. 7,582,727 and 7,598,343 were valid on all grounds.Specifically, the Court found that Hospira had failed to prove that the patents were either anticipated and/or obvious.The Court further held that the patents satisfied the written description requirement, were enabled and were not indefinite.With respect to infringement, based on its July 2013 Markman Decision, the Court found that Hospira's ANDAs did not meet the efficient mixing claim limitation and thus did not infringe the asserted claims of the '727 and '343 patents.The Court found that the other claim limitations in dispute were present in Hospira's ANDA products.The Court has not yet entered a final judgment.  Full Article

Pomerantz LLP files class action lawsuit against Medicines Co
Friday, 21 Mar 2014 04:48pm EDT 

Pomerantz LLP:Files a class action lawsuit against Medicines Co. and certain of its officers.Fiiled in United States District Court, District of New Jersey, is on behalf of all persons or entities who purchased or acquired Medicines securities between Feb. 20, 2013 and Feb. 12, 2014.Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the company's business, operational and compliance policies.  Full Article

FDA approves The Medicines Co's acute skin infection drug

- The U.S. Food and Drug Administration approved The Medicines Co's single-dose intravenous drug to treat acute bacterial skin infections, the agency's third approval for the same condition this year.

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