Drugs

FDA Accepts NDA for Sublingual Form of ALS Drug

FDA has accepted for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating patients with amyotrophic lateral sclerosis (ALS). Biohaven previously announced that the agency granted orphan drug designation for BHV-0223 in ALS. The company says BHV-0223 is a novel, lower dose formulation of riluzole, which is the only FDA-approved treatment to extend tracheostomy-free survival in people living with ALS.

The submission is supported by data from multiple studies and clinical trials evaluating the bioequivalence of BHV-0223 to riluzole oral tablets (Rilutek), as well as the safety and tolerability of BHV-0223. Data showed that sublingual administration of BHV-0223 (40 mg) achieved similar blood exposures to orally ingested Rilutek (50 mg), the company 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