STAT+: Pharmalittle: Even FDA officials balked at the broad Aduhelm label; CDC and FDA are dubious about Covid booster shots

Good morning, one and all. Damian Garde here, filling in for Ed Silverman in the morning aftermath of yet another nigh-on-Biblical bout of rain. The weekend is ever closer, but in its way is another busy work day of deadlines and projects and video calls that could just as well have been emails. Here as always are some tidbits to help you along. And if you hear anything interesting, do let us know. …

Even top FDA officials were surprised by the agency’s decision to initially grant a broad label to the Biogen (BIIB) treatment for Alzheimer’s disease, STAT tells us. Two senior staffers who were present at a key FDA meeting said they supported the idea of an accelerated approval for the treatment, Aduhelm, but were caught off guard when the agency approved it for all people with Alzheimer’s, rather than those who matched the patients in the clinical studies. One said they would never have supported the faster approval process had they known the agency was considering such a broad patient population.

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