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Stock Market & Financial Investment News

News Breaks
April 1, 2014
05:38 EDTHSP, MDCOThe 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
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June 26, 2015
07:15 EDTMDCOMedicines Co. considering strategic options for European unit, Bloomberg reports
The Medicines Co. is working with advisers from Rothschild on a review of strategic options for its European business, according to Bloomberg, citing people familiar with the matter. The review, which is at an advanced stage, may lead to a sale, licensing agreement or partnership, the report added. Reference Link
June 25, 2015
14:38 EDTMDCOMedicines Co. considering strategic options for European unit, Bloomberg says
June 24, 2015
07:06 EDTHSPHospira: FDA deems India facility 'acceptable' for manufacturing
Hospira said in a regulatory filing that on June 23, Hospira Healthcare India Private Limited, a subsidiary of Hospira, received official notification from the U.S. FDA that the inspection of the Visakhapatnam, India facility was deemed acceptable for the manufacture of finished dosage drugs. As a result of this action, the company may receive U.S. product approvals from this facility in the future. As was previously reported, the FDA conducted a pre-approval inspection of the Vizag facility from February 16 to February 25, which resulted in the issuance of a Form 483 containing 14 observations. Hospira responded to the Form 483 on March 18, and submitted additional support documentation on May 29. The inspection was found to be acceptable following the FDA’s review of the company’s responses and support documentation. The company has begun limited commercial production at the facility.
June 22, 2015
16:37 EDTMDCOThe Medicines Co. to hold a conference call
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14:33 EDTMDCOThe Medicines Co. antiplatelet drug approved by FDA
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