STAT+: Pharmalittle: FDA advisers recommend approval of controversial ALS drug; judge rules against coverage of HIV prevention drugs
Rise and shine, everyone, another busy day is on the way. We can tell by the sound of traffic outside our window and the steady parade of commuters walking to the nearby train depot. As for us, we are dutifully firing up the coffee kettle — our choice of stimulation today remains maple cinnamon French toast — and surveying our increasingly crowded calendar. Perhaps you can relate. So time to get cracking. Here is the latest menu of interesting items to help you start your own journey today. We hope all goes well and you conquer the world. And of course, do keep in touch. We are always on the prowl for new pen pals. …
At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the U.S. Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals, STAT reports. The vote was 7-2, a substantial margin of support for the Amylyx drug and a reversal by the same group that voted against the drug last March. The Amylyx drug is not a cure for ALS, but has been shown in a clinical trial to slow the progression of the neurological disease. The FDA has approved only a handful of drugs to combat ALS, but people with ALS still live an average of only four years after diagnosis.
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