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Morning Briefing

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Monday, Mar 11 2024

Full Issue

Manufacturer Of Failed ALS Drug Relyvrio Is Considering Withdrawing It

Though the FDA approved the drug less than two years ago, Amylyx's ALS drug has now failed a large clinical trial. Separately, the FDA is delaying approval for an experimental Alzheimer's drug so it can examine its effectiveness.

One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market. The medication, called Relyvrio, was approved less than two years ago, despite questions about its effectiveness in treating the severe neurological disorder. (Belluck, 3/8)

The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians, forcing the community to consider just what to do with an approved medicine that doesn鈥檛 appear to work. (Feuerstein and Garde, 3/8)

Federal regulators put off a decision on whether to approve an Eli Lilly Alzheimer鈥檚 drug by making an unusual request to have outside advisers look at the treatment. Lilly had expected the Food and Drug Administration to decide on donanemab鈥檚 approval by the end of the month. But the drugmaker said Friday that the agency now wants more information about its safety and effectiveness. No date has been set for the advisory committee meeting. (Murphy and Perrone, 3/8)

As millions of fentanyl-tainted pills inundate the United States masquerading as common medications, grief-scarred families have been pressing for a change in the language used to describe drug deaths. They want public health leaders, prosecutors and politicians to use 鈥減oisoning鈥 instead of 鈥渙verdose.鈥 In their view, 鈥渙verdose鈥 suggests that their loved ones were addicted and responsible for their own deaths, whereas 鈥減oisoning鈥 shows they were victims. (Hoffman, 3/11)

When a CEO fails to grasp the nuances of their company鈥檚 health care costs, it鈥檚 not just the bottom line that suffers. Employee efficiency and productivity could plummet, too, not to mention the corrosion of company culture. For these reasons, billionaire entrepreneur and Cost Plus Drugs cofounder Mark Cuban urges business leaders to take a hard look at how their health dollars are spent. (Leake, 3/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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