Inside FDA’s Aduhelm approval; Peter Bach heads to startup

Good morning! Elizabeth Cooney here, sitting in for Ed Silverman, who would no doubt be reminding us that we’ve made it halfway through the week, so why not carry on, cup of stimulation and clutch of news items in hand?

Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened a series of internal meetings in March and April where top officials hammered out a plan to approve Biogen’s (BIIB) Alzheimer’s drug, Aduhelm, STAT reports, based on a series of documents released Tuesday by the FDA to explain its decision to use a truncated pathway to approve Aduhelm. FDA has been criticized for departing from regulatory precedent by not judging Aduhelm based on its effect on the progression of Alzheimer’s, for which the evidence is debatable, but instead on its ability to remove beta-amyloid plaques in the brain believed to contribute to the disease.

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