New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 1, 2014
05:38 EDTMDCO, HSPThe Medicines Co. provides update on Angiomax patent litigation
On March 31, Judge Andrews in the U.S. District Court of Delaware issued his Trial Opinion in The Medicines Company v. Hospira, Inc. The case involves Hospira's (HSP) Abbreviated New Drug Applications, or ANDAs, seeking approval to commercially manufacture, use or sell a generic version of The Medicines Company's (MDCO) Angiomax bivalirudin drug product before the expiration of the patents covering this product. The Delaware Decision follows a September 23-25, 2013 bench trial. 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. Any appeal to the Court of Appeals for the Federal Circuit would need to be filed within 30 days of such entry. The '727 and '343 patents expire in 2028.
News For MDCO;HSP From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 22, 2014
09:45 EDTMDCOThe Medicines Co. says 'as open as can possibly be' to potential takeover
Subscribe for More Information
09:21 EDTMDCOThe Medicines Co. lowers 2014 revenue outlook to $720M-$735M
Subscribe for More Information
07:21 EDTHSPU.S. DHS investigates medical gear for potential cyber defects, Reuters says
Subscribe for More Information
07:11 EDTMDCOMedicines Co. says Angiomax, Angiox revenue up 5% in first nine months
Subscribe for More Information
07:06 EDTMDCOThe Medicines Co. reports Q3 EPS (26c) , consensus (12c)
Subscribe for More Information
October 20, 2014
09:48 EDTMDCOBrdiger Management reports 5.1% passive stake in The Medicines Co.
08:04 EDTHSPGerman fund pressured to sell Mylan stake over drug used in executions, FT says
Subscribe for More Information
October 19, 2014
14:18 EDTHSPFresenius, others explore bid for Danone medical nutrition unit, Reuters says
Subscribe for More Information
October 14, 2014
11:23 EDTHSPBIND Therapeutics and The Conference Forum hold a conference
Subscribe for More Information
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
Subscribe for More Information
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.
October 8, 2014
13:00 EDTHSPHospira recalling one lot of Vancomycin Hydrochloride
The FDA announced that Hospira is initiating a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride. The action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer, the agency said. It added that there have been no adverse events or complaints reported for the affected lot. Hospira is "undertaking the recall out of an abundance of caution," the FDA said.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use