Drugs

Topline Data Confirm Semorinemab Effect on Alzheimer’s

Topline Phase 2 Lauriet trial results presented by Genentech at the 14^th Clinical Trials on Alzheimer’s Disease conference reported that the treatment effect for AC Immune’s semorinemab was confirmed in the 241 trial participants who received one or more doses of the study drug. Data from the population showed a 42.2% reduction in the rate of cognitive decline with semorinemab compared to placebo, AC Immune says in a statement.

“The treatment effect was observed consistently in prespecified groups based on disease severity, baseline Tau load, and ApoE gene carrier status,” the company says.

It says safety data from the trial confirmed that semorinemab is well tolerated with an acceptable safety profile.

Semorinemab is described as an investigational monoclonal anti-tau antibody that targets the N-terminal portion of the Tau protein and is designed to bind to Tau and slow its spread between neurons. It is being studied in two Alzheimer’s disease Phase 2 studies.

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

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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