Rise and shine, another busy day is on the way. We can tell if only by the flurry of dispatches emanating from the JPM affair in San Francisco, where a long-awaited pharmaceutical industry confab is under way. Such is life in the fast lane. As for us, we are engaged in our usual routine of foraging for interesting items, which you will find below. So time to get cracking. We hope your day is productive and meaningful. And please do reach out if you hear something saucy or head spinning. We always appreciate telegrams and postcards. …
The U.S. Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies, The Wall Street Journal reports. As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a review of FDA data on clinical holds. The agency halted clinical trials for experimental drugs an average of 664 times each year from 2017 to 2021, up from 557 each of the previous five years. Through mid-December last year, the FDA had placed 747 of the holds.
FDA Commissioner Robert Califf does not disagree with the basic findings of a congressional investigation into the agency’s role in the approval of Aduhelm, the first Biogen Alzheimer’s drug, but he wishes the tone of the report had been different, STAT tells us. “There were no surprises in the report,” Califf said during an evening event at the J.P. Morgan Healthcare Conference. “The language is inflammatory, I think, on purpose, because that’s what oversight committees do.” These were his first public remarks since a recent congressional investigation delivered an in-depth critique of both the FDA’s and Biogen’s handling of the Aduhelm approval in 2021.
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