"Today's announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease, and provide a clinically meaningful impact on cognition and function," said Michel Vounatsos, Chief Executive Officer at Biogen.
Drug companies have struggled through a long list of failed clinical trials with amyloid-targeting drugs. Biogen's Aduhelm became the first new amyloid-targeting Alzheimer's drug to gain FDA approval last year. It was controversial because it was based on two studies that ended prematurely and yielded mixed results.Brain stimulation could make a 'moderate to large' difference, study shows.
Haruo Naito, Eisai's Chief Executive Officer, said the lecanemab study results"prove the amyloid hypothesis, in which the abnormal accumulation of in the brain is one of the main causes of Alzheimer's disease." If lecanemab secures FDA's accelerated approval in January, Eisai will quickly seek the more conventional, full FDA approval so patients can access the drugs outside of a clinical trial, said Ivan Cheung, Eisai's United States CEO.
We have summarized this news so that you can read it quickly. If you are interested in the news, you can read the full text here. Read more:
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Breast implants are linked to several cancers, FDA warnsThe U.S. FDA warns that breast implants filled with silicone or saline could give rise to cancer in the scar tissue around breast implants.
Source: IntEngineering - 🏆 287. / 63 Read more »
Insider Q&A: FDA official on vaping's 'promise or peril'The new chief at the Food and Drug Administration's tobacco center has inherited a raft of problems.
Source: ksatnews - 🏆 442. / 53 Read more »
Pfizer-BioNTech asks FDA to authorize new omicron-targeting COVID booster for children 5 to 11Pfizer-BioNTech submitted an application for the FDA to authorize its BA.4/BA.5 bivalent COVID-19 vaccine for kids 5 to 11 at a 10-microgram dose.
Source: USATODAYhealth - 🏆 706. / 51 Read more »
FDA Clears New AI Device to Aid Polyp Detection🆕 The FDA has granted 510(k) marketing clearance to a new AI–assisted polyp detection device for use during colorectal cancer screening. FDAapproves GastroTwitter
Source: Medscape - 🏆 386. / 55 Read more »
Congress moves forward with 'clean' deal to fund FDAFunding for the FDA’s work will continue without efforts to increase oversight — at least for now — as Congress moves forward with a Republican-backed “clean” deal to extend FDA user fees for 5 years. I'm excited that the new and improved GOP will be winning back both the US House and Senate this November.
Source: axios - 🏆 302. / 63 Read more »
Pfizer asks FDA to approve omicron COVID-19 booster shots for 5- to 11-year-oldsElementary-aged children already received smaller doses of Pfizer’s original COVID-19 vaccine, a third of the dose given to everyone 12 and older. No. I think it's highly suspicious how people getting tested at hospitals for Covid with little to no symptoms get extremely sick after the tests... BTW the UK is paying out people who had adverse effects from the vaccine
Source: FOXLA - 🏆 445. / 53 Read more »