Drugs

FDA Rejects Anti-Sweating Gel

FDA has sent Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating primary axillary hyperhidrosis. The company says it will need to revise the printed Instructions for Use document proposed for inclusion with the product, and other unspecified points raised in the letter. It notes that no clinical efficacy, safety or manufacturing issues were cited in the letter, and no additional clinical studies are required to support approval. An NDA resubmission is expected in the first quarter of 2024, which could lead to an approval by mid-year.

New chemical entity sofpironium bromide is described as an anticholinergic/antimuscarinic drug that blocks sweating at the gland by binding to the receptor and thereby blocking the sweat signal. The company says about 85% of patients using the gel experienced a clinically meaningful improvement in their condition over the course of its Phase 3 studies. It adds that there were no treatment-related serious adverse events in any of the studies and adverse events were characterized as transient and mild to moderate in nature.

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