Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.

Shares of Eli Lilly and Co. (NYSE:LLY) leapt 11.7% to $185.94, their second biggest gain since 2010, after a phase II trial showed its beta-amyloid-targeting monoclonal antibody, donanemab, appeared to slow by 32% decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease vs. placebo.

Lexeo Therapeutics Inc., a New York-based startup initially advancing clinical and near-clinical stage candidates for Friedreich’s ataxia, CLN2 and Alzheimer's diseases, has raised an $85 million series A financing round led by Longitude Capital and Omega Funds. Founded by gene therapy development veteran Ronald Crystal, the company is led by CEO Nolan Townsend, the former head of Pfizer Inc.'s rare disease efforts in North America.

DUBLIN – Could a tyrosine kinase inhibitor approved for treating canine cancer offer clinical benefits in Alzheimer’s disease? That’s the bold claim AB Science SA is making, after unveiling top-line data from a phase IIb/III trial in which it reported that a subgroup of patients on a twice daily 4.5-mg/kg dose of oral masitinib experienced “a significant treatment effect” as compared with placebo after 24 weeks.

Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.

HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints.

As cases skyrocket and more questions arise about the high rate of false negatives returned by rapid testing in COVID-19 cases, a simple, new diagnostic test offers far greater accuracy. Researchers around the globe have found that artificial intelligence can detect coronavirus infections in recorded forced coughs, with nearly 100% accuracy in asymptomatic or presymptomatic cases, making it an ideal quick screening test. Forced cough or voice analysis shows strong results in other conditions, too, including pulmonary hypertension and, surprisingly, Alzheimer's disease.

Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.

The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo.