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.
The U.S. Department of Health and Human Services is gearing up to start releasing details about its new Medicare drug-price negotiation process this year, and the public will have more of a chance to weigh in along the way than initially expected, STAT writes. The Inflation Reduction Act, which established Medicare’s new negotiation powers, did not explicitly require the agency to get public input before setting up the program, but HHS outlined several opportunities it will be publicizing anyway. The agency also laid out a detailed timeline of key dates when drugmakers, policy experts, insurers, and patients can expect more details about the Medicare negotiation program.
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