Michel Vounatsos (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen CEO Vounatsos laments 'con­fu­sion' and 'mis­in­for­ma­tion' lead­ing to chal­lenges with Aduhelm up­take

Bio­gen CEO Michel Vounatsos on Thurs­day ad­mit­ted the com­pa­ny is ex­pe­ri­enc­ing some “near term chal­lenges” in launch­ing its con­tro­ver­sial new Alzheimer’s drug, a lit­tle more than two months since win­ning an ac­cel­er­at­ed ap­proval.

“There is clear­ly too much con­fu­sion, mis­in­for­ma­tion and con­tro­ver­sy sur­round­ing our da­ta and the ap­proval process,” Vounatsos said at a JP Mor­gan health care con­fer­ence. In­deed, the HHS In­spec­tor Gen­er­al has opened an in­ves­ti­ga­tion in­to the ap­proval, in ad­di­tion to an in­ter­nal FDA in­ves­ti­ga­tion, which was re­vealed by a Con­gres­sion­al in­ves­ti­ga­tion in­to the ap­proval and the close ties be­tween FDA and Bio­gen.

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