
A congressional investigation found the FDA’s interactions with Biogen were “atypical and failed to follow” protocol and that the two “inappropriately collaborated” on documentation before the approval of Aduhelm for Alzheimer’s disease.
In addition, Biogen — the manufacturer of Aduhelm (aducanumab) — originally set “an unjustifiably high price” for the drug to “make history” for the company, according to the executive summary of the investigation. According to internal documents, Biogen had initially set the price of