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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The (virtual) doors closing on the J.P. Morgan Healthcare Conference is the sign for the biopharma industry that the new year has truly started, but before we get too far into 2021, Scrip has taken a look at five of the biggest non-COVID-19 story themes of 2020 in no particular order.
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.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.