HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.

Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.”

Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.”

Cognito Therapeutics Inc. has revealed that its lead product has received breakthrough device designation from the U.S. FDA for the treatment of cognitive and functional symptoms associated with Alzheimer’s disease. The offering is a noninvasive neurostimulation device using gamma frequency technology and is the initial candidate in the company’s pipeline of digital therapeutics for neurodegenerative diseases and other chronic indications.

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.