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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of Jan. 23, 2012: 2012 Facility of the Year Awards are Announced; Suzhou Pharma Services Names Oliver Mueller President; and More
Alnylam Pharmaceuticals, a company specializing in RNA interference (RNAi) drug development, has announced plans to implement a corporate restructuring, including an approximate 33% reduction in its workforce, in order to align resources with its clinical-development program. The company is focusing on its Alnylam 5x15 RNAi therapeutic product strategy, which is a company strategy launched in January 2011 to develop and commercialize novel RNAi therapeutics. Two lead programs are ALN-TTR, to treat transthyretin-mediated amyloidosis, and ALN-APC to treat hemophilia. Read More
FDA has issued a complete response letter to AstraZeneca and Bristol-Myers Squibb regarding the companies’ new drug application for the investigational compound dapagliflozin for treating Type II diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the risk–benefit profile for dapagliflozin. This includes clinical-trial data from ongoing studies and may require information from new clinical trials. Read More
The International Society of Pharmaceutical Engineers (ISPE) and Interphex have recognized the 2012 recipients of the Facility of the Year Awards, an annual recognition of innovation and accomplishments in facility design, construction and operation. Awards were given in the following categories:
For additional details of the project work, Read More
Merck & Co. has agreed to resolve all claims related to its nonsteroidal anti-inflammitory drug Vioxx (rofecoxib) in Canada. The agreement was signed by Merck and plaintiffs’ representatives and is pending approval by courts in Canada’s provinces. If the agreement is approved and specified conditions are met, Merck will pay a total amount of at least C$21.8 million ($21.7 million) but not more than C$36.9 million ($36.7 million). This would resolve all Vioxx certified class actions, putative class actions, other litigation and claims related to Vioxx in Canada. The amount to be funded for Vioxx users in Canada will be between C$11.3 million ($11.2 million) and C$26.4 million ($26.2 million) and will be determined by the final number of eligible claimants. Read More
In other news:
Congresswoman Mary Bono Mack (R-CA) has written a letter criticizing FDA for lack of oversight of Novartis’s Novartis’s consumer-healthcare manufacturing facility in Lincoln, Nebraska.
Pharmaceutics International has begun construction of a new aseptic fill–finish manufacturing facility.
Oliver Mueller has been appointed as president of Suzhou Pharma Services, effective Jan. 3, 2012. Suzhou Pharma Services, an affiliate of Amerigen Pharmaceuticals, is a CDMO focused on oral solid-dose forms.
In other news: