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FDA conjures PML specter ahead of Takeda adcom

By Mari Serebrov
Washington Editor

Thursday, December 5, 2013
Shades of Tysabri could haunt Takeda Pharmaceutical Co. Ltd.’s vedolizumab when it comes before a joint advisory committee meeting Monday. Although no cases of progressive multifocal leukoencephalopathy (PML) appeared in clinical trials of Takeda’s gut-selective humanized monoclonal antibody being developed for ulcerative colitis and Crohn’s disease, the FDA raised the specter of PML in its briefing document.

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