Biogen’s Twisting Path To The Aducanumab Advisory Committee
Our graphical timeline shows Aducanumab’s ups and downs, from IND to accepted BLA, and the many meetings with US FDA staff that helped move the program forward.
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Agency thinks Biogen’s sucessful Phase III study supports approval, but given the negative outcome of another trial and disease-modifying mechansim of action, an advisory committee endorsement could go a long way in assuring the public the Alzheimer's drug actually works; the panel will comprise 11 voting members, four of whom were added as temporary members for their expertise in neurology, biostatistics and patient advocacy.
Chamber files petition to have FTC amend its disqualification rules to have commissioners explain their rejection of recusal requests. FTC is seeking public comments on the petition.