In late April 2012, Aptalis Pharmatech and Teva Pharmaceutical’s subsidiary Cephalon won their appeal to the US Court of Appeals for the Federal Circuit to reverse a lower court’s determination and held that two patents covering the Amrix (cyclobenzaprine hydrochloride extended-release capsules) muscle relaxant are valid. The two patents, owned by Aptalis Pharmatech and licensed to Cephalon, expire in 2023 and 2025. The patents, along with other additional patents that protect Amrix, are all listed on the FDA’s Orange Book and will be enforced to the fullest extent possible. Read More

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GlaxoSmithKline (GSK) has agreed to acquire the shares that it does not currently own in Cellzome, a company that specializes in the development of proteomics technologies, for £61 million ($99 million) in cash. Cellzome has laboratories in Cambridge, United Kingdom, and Heidelberg, Germany, and will become part of GSK’s R&D organization. Read More

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Hospira announced that it is initiating a voluntary user-level recall of one lot of hydromorphone injection, USP, 1-mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1-mL labeled fill volume. The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL. The expiration date is July 1, 2013. The affected lot was distributed in September–October 2011. Hospira plans to undertake this recall in consideration of the potential for safety issues if the product is administered to patients. Read More

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The CDMO Patheon is continuing to restructure its commercial and pharmaceutical development services (PDS) networks. As part of this process, the company plans to make several adjustments over the next 24 to 36 months to the scale and scope of business conducted at its Swindon, United Kingdom, facility. The adjustments will include winding down or transferring noncephalosporin commercial production to other facilities and directing PDS projects that require commercialization activities to other facilities. The company will be working with each of its affected commercial customers to develop plans to maintain supply-chain continuity to the extent possible and commercially appropriate. The company will take an impairment charge ranging from approximately $50 to $60 million to be recorded during the second quarter of 2012. In addition, the company announced a workforce reduction of approximately 91 employees across its global PDS and commercial operating segments, and has begun the consultative process with the works councils representing the employees at the Swindon and Milton Park facilities. Subject to these consultations, the company expects to complete its plan of termination across all affected sites by the end of fiscal year 2012. In connection with its plan of termination, the company expects to incur approximately $5.4 million of expense associated with employee termination benefits, to be recorded during the second quarter 2012, and anticipates that it may further adjust the size of the workforce at the Swindon facility as it continues its transformation process, with a total of approximately 400 jobs at risk of redundancy. Read More

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The CDMO Vetter has invested in its Ravensburg (Germany) Vetter West facility, a new center for visual inspection and logistics. The new facility offers high-bay warehousing capacity for cool and room-temperature goods. The EUR 35-million ($44.6 million) facility will serve as a workplace for up to 400 employees. Read More

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Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More