Drugs

Emalex’ Ecopipam Meets Tourette Study Endpoints

Emalex Biosciences says its lead candidate drug ecopipam, a novel dopamine-1 receptor antagonist, met its primary and secondary endpoints in a Phase 3 Tourette syndrome study. Company officials say they plan to meet with FDA to discuss submitting an NDA later this year for ecopipam to treat patients with Tourette syndrome.

Some 167 pediatric and 49 adult subjects with Tourette syndrome were enrolled in the Phase 3 study, the company says. The primary efficacy endpoint was time to relapse for pediatric subjects following randomization to ecopipam or placebo, while the secondary endpoint was time to relapse for both pediatric and adult subjects following randomization. The company says the drug was well tolerated in the study. The most common adverse effects were somnolence, insomnia, anxiety, fatigue, and headache, it says.

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