And so, another working week will soon draw 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 shaping up, to be honest. We do, however, hope to find time to catch up on our reading, have a listening party with Mrs. Pharmalot, and, of course, promenade with our official mascot. And what about you? Autumn is here, so this presents another wonderful opportunity to enjoy the great outdoors — perhaps, a long walk or long drive is in order. You could stock up on pumpkins and apples along the way. You could also stock up on winter gear before prices rise still more. Or if you feel a little social, you could make time for someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The U.S. Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals, providing a desperately needed new treatment option for a devastating disease, STAT writes. The medicine, called Relyvrio, is not a cure but proved to moderately slow the progression of the neurological disease, which causes weakened muscles, paralysis, and death. Amylyx did not immediately disclose how much it will charge for Relyvrio, but the company is conducting a larger, longer clinical trial to confirm the benefits, with data expected in late 2023 or early 2024. In a rare commitment, the company has promised to remove the drug from the market if that study is not successful.
Medicare’s drug-price negotiations are poised to turn into a legal battle as the government works out implementation rules and critics eye ways to skirt limits on lawsuits, Bloomberg News writes. The Inflation Reduction Act will empower the government to negotiate prices of certain drugs for the first time starting in 2023, putting drug companies on the hook to participate. Language in the law barring judicial review of how Medicare determines which drugs are eligible for negotiation will make any challenge tricky. Potential avenues for lawsuits will include invoking the U.S. Constitution, and any lawsuit could delay negotiations while increasing leverage through political bargaining.
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