New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 11, 2012
06:43 EDTHSPHospira downgraded to Sell from Neutral at Goldman
News For HSP From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
July 2, 2015
12:40 EDTHSPMedicines Co. says appeals court rules against company in Angiomax litigation
Subscribe for More Information
10:17 EDTHSPAppeals court reverses lower court patent ruling in Medicines Co. case
The Medicines Company (MDCO) owns U.S. patent no. 7,582,727 and U.S. patent no. 7,598,343, which relate to the drug bivalirudin, a synthetic peptide used as an anti-coagulant that the company sells under the Angiomax brand. On August 19, 2010, The Medicines Company sued Hospira (HSP), alleging that two of Hospira’s ANDA filings infringe claims 1–3, 7–10, and 17 of the ’727 patent and claims 1–3 and 7–11 of the ’343 patent. A district court previously construed the asserted claims and, after a bench trial, found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar. The Medicines Company appealed the U.S. District Court for the District of Delaware’s claim construction and non-infringement findings, while Hospira, crossappealed the district court’s determination that the asserted claims are not invalid under the on-sale bar, obviousness, or indefiniteness. The U.S. Court of Appeals for the Federal Circuit has now concluded that the district court "clearly erred" in finding that the bivalirudin batches prepared by Ben Venue Laboratories before the critical date were not sold to The Medicines Company and were prepared primarily for an experimental purpose. Accordingly, the federal appeals court reversed the district court’s validity determination and held the asserted claims invalid under the onsale bar. Shares of Medicines Co., which initially fell amid headlines regarding the ruling, are now up 4.5% to $29.61, while Hospira is flat at $88.90.
09:57 EDTHSPMedicines Co. loses appeal in Hospira suit over Angiomax patents, Bloomberg says
Subscribe for More Information
09:50 EDTHSPThe Medicines Co. drops 3.2% to $27.43 in early trading
Subscribe for More Information
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.

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