STAT+: Pharmalittle: European regulators unlikely to approve Biogen Alzheimer’s drug; U.S. to invest billions to expand Covid vaccine production

Hello, everyone, and welcome to the middle of the week. You made it this far, so why not continue, yes? Perhaps a cup or two of stimulation is in order. Our choice today is maple bourbon. As you know, a prescription is not required. So feel free to indulge as you attack the laundry list of meetings and deadlines that await. Meanwhile, we have once again assembled a list of tidbits for you to peruse and help you on your way. Hope you have a smashing day and, as always, do drop us a line when you hear something interesting. …

A European Medicines Agency panel notified Biogen (BIIB) that its Alzheimer’s treatment is unlikely to win approval, STAT reports. The drug, known as Aduhelm, received a “negative trend vote” following a type of hearing called an oral explanation that was held Nov. 9. Biogen addressed the panel in an attempt to resolve outstanding concerns about the drug, but the hearing concluded with reviewers issuing a preliminary recommendation that Aduhelm should not be approved. Unless the vote is reversed, which typically does not happen, a formal scientific opinion will be issued at the December meeting of the Committee for Medicinal Products for Human Use.

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