Drugs

FDA Grants Fast Track for Alzheimer’s Drug

FDA has granted Bristol Myers Squibb fast-track status for its investigational Alzheimer’s therapy BMS-986446. The anti-microtubule binding region tau (anti-MTBR-tau) antibody is currently in Phase 2 testing for patients with early disease.

The company says BMS-986446 is designed to target fragments of tau containing the microtubule binding region, which are believed to drive disease progression. By neutralizing these fragments and promoting their clearance, the drug aims to slow or delay the course of Alzheimer’s, it explains.

Preclinical studies showed that the drug reduced tau spread and protected against behavioral deficits, while an earlier Phase 1 trial found it to be safe and well-tolerated in healthy participants, according to the company. The fully enrolled Phase 2 TargetTau-1 study is now underway globally, testing multiple doses in patients with early Alzheimer’s and incorporating biomarkers of tau and amyloid-beta, alongside clinical measures of disease progression, it adds.

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