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TRIALS AND TRIBULATIONS

MedImmune to Cut 200 Jobs in California

The weekly round-up of failed trials, missed targets and other business mishaps.

The Burrill Report

MedImmune, the biologics unit of AstraZeneca, will cut 200 jobs and close its Mountain View and Santa Clara locations, but will add jobs to its Hayward location. The reorganization will affect MedImmune’s infectious disease and vaccines research and development operations. In total, 300 jobs will be affected, but 100 of those jobs will be shifted to existing facilities. The changes will be completed in 2014 in an effort to create a seamless transition of ongoing activities. MedImmune also said that the restructuring will not interfere with the company’s ability to deliver its vaccines.

Bristol-Myers Squibb said that its investigational drug for the treatment of liver cancer, brivanib, failed to meet the primary endpoint in a late-stage non-inferiority study against Bayer and Onyx Pharmaceutical’s Nexavar as a first-line treatment for patients with advanced hepatocellular carcinoma. Brivanib had previously failed to meet the primary goal in a late-stage study testing its overall survival versus a placebo. Bristol-Myers says it will now consider other options regarding the development of the program.

The decision on whether or not to grant approval of Novo Nordisk’s insulin product, degludec, for the treatment of diabetes will be delayed. The U.S. regulatory advisory panel hearing date has been moved to November 8, past the current PDUFA date assigned for degludec, which was in August 2012.

Johnson & Johnson has recalled more than 53,000 Duragesic pain-relief skin patches because at least one of the patches in the lot had small crystals of the potent active ingredient. J&J voluntarily recalled one lot of its Duragestic patches from wholesalers and noted that the affected lot was safe and effective. J&J has not received any reports of adverse health events associated with the product quality in the recalled lot. According to an FDA notice, the recalled product “exhibited white spots, which were determined to be small fentanyl crystals,” something the pain-relief patches are not supposed to have.


July 20, 2012
http://www.burrillreport.com/article-medimmune_to_cut_200_jobs_in_california.html

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