Drugs

Alzheon Alzheimer’s Trial Misses Primary Endpoint

Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimer’s disease (AD) patients did not meet its primary endpoint of slowing cognitive decline in the overall population. While it missed the endpoint, the company says promising results emerged in a prespecified subgroup of patients at the mild cognitive impairment stage. In these patients, valiltramiprosate demonstrated statistically significant cognitive benefits and clinically meaningful improvements in functional measures such as the Clinical Dementia Rating–Sum of Boxes and Disability Assessment for Dementia, it says.

The study evaluated valiltramiprosate in patients with early Alzheimer’s disease who are homozygous carriers of the APOE4 gene — a high-risk population for developing AD. Imaging data showed slowed brain atrophy in multiple regions, including hippocampal volume, suggesting potential neuroprotective effects, the company says. It adds that importantly there was no increased risk observed of amyloid-related imaging abnormalities, such as brain edema or microhemorrhages.

Alzheon plans to expand its research to include prevention strategies for APOE4 carriers and explore potential applications for broader AD populations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome