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News Breaks
June 6, 2014
14:32 EDTHSPHospira issues statement on paclitaxel supply and pricing
The company said, "Given recent misinformation, we at Hospira Canada feel it is very important to clarify and provide further context regarding the Canadian supply and pricing of paclitaxel – a life-saving cancer medication. Most importantly, through Hospira's efforts, and working closely with Health Canada, a severe oncology treatment crisis was avoided, resulting in no patient disruption of a key oncolytic therapy. Contrary to media reports, Hospira did not increase our price for paclitaxel. In fact, Hospira offered a 75 percent discount off our list price of paclitaxel to Canadian purchasing groups that previously purchased the drug from another supplier that is not currently able to supply the market. The price referenced in media coverage is the list price for paclitaxel. Because we recognize the importance of paclitaxel, we offered this deep discount well before the issue became public by directly engaging each affected purchasing group in May, along with a firm commitment to apply the discount retroactively. We're hoping to quickly finalize agreements with the key purchasing groups that supply Canadian hospitals so they can obtain the discounted price and not pay the list price. It is expensive and complicated to meet this large, unexpected and sudden increase in demand. As well as offering the 75 percent discount, we have taken the following actions to ensure a smooth supply: We have increased local inventory levels across our portfolio to meet spikes in demand when shortages arise; We have expedited delivery to Canada ahead of other markets, while balancing the needs of our global patient base; We have worked with customers across the country to allocate inventories from institutions that had higher levels of inventory to where needs were critically necessary; We have made corporate investments exceeding $1 billion in recent years to expand production to provide a reliable supply of medically necessary products and prevent drug shortages, as we have been able to do with paclitaxel in Canada. Hospira has built a strong record in Canada, specifically in Montreal, with roots that date back to 1927, employing nearly 200 skilled and highly-trained individuals. We are proud to build on this heritage by quickly mobilizing our operations to provide life-saving cancer treatments to all Canadian patients who require them."
News For HSP From The Last 14 Days
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July 2, 2015
12:40 EDTHSPMedicines Co. says appeals court rules against company in Angiomax litigation
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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
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09:50 EDTHSPThe Medicines Co. drops 3.2% to $27.43 in early trading
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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.

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