Hello, everyone, and how are you today? We are just fine, thank you, despite gray skies hovering over the Pharmalot campus. Despite the looming rain, our spirits remain sunny. As the Morning Mayor taught us long ago: Every new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will fire up the coffee kettle for another needed cup of stimulation. Our choice today is glazed doughnut. Yum. Meanwhile, here are a few choice items of interest we have assembled for you. Hope your journey is smooth, and do stay in touch. …
Since the controversial approval of the Alzheimer’s drug Aduhelm, both the Food and Drug Administration and Biogen (BIIB) have made an interesting argument: that approving the medicine will speed the development of other Alzheimer’s treatments, whatever one thinks of this medicine’s efficacy. Call it the “Field of Dreams” theory of drug development: If the FDA approves some medicines, more will be invented. But is this really true, STAT asks. Here’s what everyone agrees on: money.
Seven members of the FDA advisory panel that reviewed Biogen’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” The opinion piece in The New England Journal of Medicine is another sign of persistent furor over the agency’s decision, Bloomberg News notes. Two committees of the House of Representatives investigating the approval have asked Biogen to turn over documents about the drug’s development and approval.
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