The FDA placed a partial clinical hold on atuzaginstat (COR-388) from Cortexyme Inc., of South San Francisco, stating that no new participants should be enrolled in the open-label extension portion of the phase II/III GAIN trial in mild to moderate Alzheimer’s disease.
Nearly five months after its tau-directed antibody, semorinemab, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease, AC Immune SA is back with positive data on a different approach with its anti-phospho-tau vaccine candidate, ACI-35.030.
A definitive diagnosis of Alzheimer’s disease often isn’t arrived at until after a patient dies, when their brain is examined during autopsy. Neurovision Imaging Inc. is hoping to change that with reliable, affordable biomarker tests that can detect Alzheimer’s and other forms of dementia and neurodegenerative disorders before symptoms appear.
When Cassava Sciences Inc.’s president and CEO, Remi Barbier, opened up the interim analysis of the company’s open-label study for Alzheimer’s disease candidate simufilam, he was more than pleased with the results but found himself an audience of one. His researchers had been confident about the results before the data were tallied. “I was ecstatic,” he told Bioworld. “No one’s seen this type of improvement in Alzheimer’s. But our scientists said, ‘See, I told you so.’ It was not my expectation.” The new data showed six months’ treatment with the oral, small molecule not just stabilized but improved cognition and behavior scores in AD patients.
Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
LONDON – Remynd NV has extended its series B, raising a further €12 million and bringing the total for the round to €24 million (US$29 million). The new money will fund clinical proof-of-concept trials in the diverse indications of Alzheimer’s disease and diabetes.
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.”
