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☆ F.D.A. Delays Action on Closely Watched Alzheimer’s Drug
▼ + stars: | 2024-03-08 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration has decided to delay action on a closely watched Alzheimer’s drug, donanemab, which the agency was widely expected to approve this month. will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug’s maker, Eli Lilly and Company, said Friday. The decision is likely to surprise many Alzheimer’s experts, doctors and patients who had expected the medication would soon be on the market. The F.D.A.’s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year. “We were not expecting this,” Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview.

Persons: Eli Lilly, “, Lilly, ” Anne White, ” Organizations: Drug Administration Locations: donanemab

☆ Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.

Persons: Eli Lilly, Eli Lilly's, Leqembi, Anne White Organizations: and Drug Administration, FDA Locations: Indianapolis , Indiana, Biogen

☆ Lilly drug slows Alzheimer's by 60% for mildly impaired patients in trial
▼ + stars: | 2023-07-17 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

Lilly expects the U.S. Food and Drug Administration to decide by the end of this year whether to approve donanemab. The company had previously reported that 24% of the overall donanemab treatment group had brain swelling. The deaths of three trial patients were linked to the treatment, researchers reported. For high tau patients, donanemab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low-to-intermediate tau levels. Both medications are also being studied in large trials to see if they have an impact on delaying onset of Alzheimer's disease symptoms.

Persons: Seth Gale, Brian Snyder, Eli Lilly, Anne White, Lilly, Susan Kohlhaas, Liana Apostolova, White, Liz Coulthard, donanemab, Deena Beasley, Ludwig Burger, Will Dunham, Bill Berkrot, Caroline Humer Organizations: Alzheimer Research, Brigham, Women’s, REUTERS, Alzheimer's Association International, U.S . Food, Drug Administration, Alzheimer’s Research, Indiana University School of Medicine, Doctors, University of Bristol, JAMA, FDA, Alzheimer's Association, Health Organization, New York Stock Exchange, Thomson Locations: Boston , Massachusetts, U.S, Amsterdam, Eisai

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

☆ Alzheimer’s patients may wait years to get treated with new drugs, putting them at risk of more severe disease
▼ + stars: | 2023-04-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +17 min

But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.

☆ Endeavor shares fall after video shows UFC boss Dana White hitting wife on New Year's Eve
▼ + stars: | 2023-01-03 | by ( Lillian Rizzo | ) www.cnbc.com time to read: +1 min

Dana White appears at the UFC 282 post-fight press conference on December 10, 2022, at the T-Mobile Arena in Las Vegas, NV. Media and entertainment company Endeavor saw its shares fall on Tuesday after a video showing Dana White, the president of its Ultimate Fighting Championship business, slapping his wife. Endeavor shares were down more than 7% on Tuesday afternoon. In the video, it appears the two are arguing before Anne White slaps Dana White. Anne White also issued a separate statement to TMZ, calling it isolated incident.

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