Drugs

FDA Says FAAH Drugs in U.S. Development Safe After French Mishap

FDA has completed a comprehensive review of safety information related to fatty acid amide hydrolase (FAAH) inhibitors under development in the U.S and determined that toxicity seen with a similar drug in France does not extend to others in the drug class. Earlier this year, the agency and European regulators began reviewing safety data after a Phase 1 trial, conducted by French clinical research organization Biotrial, resulted in the death of one enrolled patient and neurological injury to four others (see earlier story). The study involved Portuguese company Bial’s BIA 10-2474 and its use in neurological disorders.

“Based on these findings, the FDA is working with sponsors to establish the appropriate path forward for FAAH inhibitors under investigation in the U.S.,” an updated safety notice says. “We are also working to ensure healthy subjects, patients, and investigators participating in FAAH inhibitor clinical trials are fully informed of the risks and potential benefits of these experimental therapies.”

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