Drugs

Neurelis NDA for Epilepsy Nasal Spray

Neurelis has filed an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. The proprietary formulation of diazepam incorporates a combination of a vitamin E-based solution and Intravail, an absorption enhancement, according to the company.

The submission is supported by data from studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 1,600 seizures have been treated with the nasal spray. In the trials, Valtoco demonstrated “high bioavailability, low variability from dose to dose, and was well-tolerated,” the company says. The agency in 2015 granted Neurelis an orphan drug designation for the product and in 2016 it was granted a fast track designation.

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

Read more

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