Drugs

Mitsubishi Tanabe NDA for Oral ALS Drug

FDA has accepted for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sclerosis (ALS). The company says that oral edaravone has been developed to have a similar clinical profile compared to the intravenous formulation of Radicava (edaravone), which was approved by the agency 5/2017. FDA has set a user fee review action target date of 5/12.

The submission is based on data from the RADICAVA IV pivotal trial and seven Phase 1 clinical pharmacology studies examining the pharmacokinetics, safety, drug-drug interactions, dosing, bioavailability and bioequivalence of the oral suspension in healthy individuals and ALS patients, according to the company. It says an ongoing study is also evaluating the safety and tolerability of the oral suspension at 48 and 96 weeks.

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