New Body Blow For Aducanumab As Japan Asks For More Data
Request for additional data after a surprise review committee meeting sets back approval in potentially large market, adding to Biogen and Eisai’s woes following the recent EU negative opinion and poor performance and price cut in the US.
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Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is much faster than the nine years required by US FDA under the accelerated approval.
The first disease modifying drug for Alzheimer's disease will be priced at a $56,000 a year for an average weight patient, setting the drug up to be a mega blockbuster if Biogen can get it reimbursed.
In this week's podcast edition of Five Must-Know Things: GSK’s R&D head departs; Bayer’s pharma R&D chief prioritizes assets; new US launches in atopic dermatitis; is Abivax an M&A target; and China’s gene therapy developers rush to the clinic.