And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, escorting Mrs. Pharmalot to a speakeasy and, if time permits, holding another listening party, where the rotation will likely feature this, this, this, this and this. And what about you? Once again, we will remind you that the great outdoors is beckoning. With this in mind, time to grab your beach gear or strap on your hiking boots. If the weather fails to cooperate, you could always stroll around a museum, check out the new arrivals at your local library or curl up in front of the telly. Or maybe this is an opportunity to sit on the phone and reach out to a few special people. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
The U.S. Food and Drug Administration cleared Replimune’s treatment for advanced melanoma, dealing the biotech a major win after a tumultuous saga of trying to seek approval for the controversial treatment, STAT notes. The decision to grant accelerated approval to the drug, which will be marketed as Tudriqev, came after its FDA advisers last week voted in support of the treatment. Even though FDA staff expressed concerns about the design and conduct of the key trial, advisers ultimately believed there was a large enough signal of efficacy and that patients are in urgent need of new treatments.
A little-noticed policy shift by Medicare caused a seven-year delay in choosing a costly AbbVie medicine for price negotiations, a move likely to hurt taxpayers, writes, citing an analysis by a consumer advocacy group. The change occurred as the Centers for Medicare and Medicaid Services readied a new round of talks with drugmakers over prices the agency would pay for a limited number of drugs. The process was created by the Inflation Reduction Act. But CMS modified criteria for selecting drugs for the negotiations, which transformed the process for determining when certain medicines would become eligible for the talks. And it was done in a way that benefited AbbVie and may help other drugmakers in the future.
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