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Sep 03, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Lemtrada regulatory update

FDA refused to file an sBLA from Sanofi's Genzyme Corp. subsidiary for Lemtrada alemtuzumab to treat multiple sclerosis. According to Genzyme, the agency asked the company to "modify the presentation of the data sets to enable the agency to better navigate the application." The agency did not request additional data. Genzyme said it plans to resubmit the application "as...

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