Drugs

FDA ‘Confers’ With EU Counterparts on Fatal Trial in France

FDA says it is “conferring” with European regulators after a Phase 1 trial, conducted by French clinical research organization Biotrial, resulted this week in the death of one enrolled patient and neurological injury to four others. The study involved Portuguese company Bial’s BIA 10-2474 and its use in neurological disorders. “Although no clinical studies with BIA 10-2474 have occurred in the U.S., FDA is conferring with the European Medicines Agency (EMA) and the French national medicines agency (ASNM),” an agency notice says. “FDA will learn as much as possible about BIA 10-2474 and the results of the French Phase 1 study.”

BIA 10-2474 is described as an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. “FAAH inhibitors have been studied for their potential therapeutic use in a number of neurological disorders,” FDA says. “This week’s tragedy in France is the first human fatality following exposure to an FAAH inhibitor.”

FDA says it is collecting and reviewing safety information pertinent to FAAH inhibitors under investigation in the U.S. “FDA will work with sponsors to ensure the safety of participants in clinical studies and take regulatory action as appropriate,” it says. “FDA will also work with sponsors to ensure patients and investigators participating in clinical studies of FAAH inhibitors are fully informed regarding the risks and potential benefits of these drugs.”

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