STAT+: Pharmalittle: HHS readying details for Medicare drug-price negotiations; doctors urge FDA to hold expert meeting before approving Alzheimer’s drug

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation. Our choice today is Swiss chocolate almond. As always, we invite you to join us. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. We are quite tickled when folks offer to become our pen pals. …

A physicians group is urging the U.S. Food and Drug Administration to hold an expert panel meeting to review an experimental Alzheimer’s drug before issuing a full-blown approval, a move that reflects nagging safety issues surrounding the medication, STAT says. The appeal follows the FDA’s decision, announced last week, to grant accelerated approval for the medicine, Leqembi. Accelerated approval is a faster path to the marketplace based on preliminary clinical trial evidence. The companies behind the drug – Eisai and Biogen – are expected to provide still more data shortly so the FDA can consider a final approval. So far, the FDA has not indicated whether an advisory committee will be convened.

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