Drugs

Tonix Fibromyalgia Test Misses Endpoint

Tonix Pharmaceuticals says that preliminary topline results from its Phase 3 AFFIRM study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg in patients with fibromyalgia failed to achieve statistical significance in its primary efficacy endpoint of the proportion of patients who reported a 30% or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis. The company says that the drug showed statistically significant effects on pain when analyzed by other statistical approaches, however.

Company president Seth Lederman said that the drug “showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the AFFIRM study.” He said that despite achieving clinically meaningful results from AFFIRM, the company has greater clarity on the regulatory approach forward in its post-traumatic stress disorder (PTSD) program and will move that into Phase 3. For PTSD, the drug is intended to provide broad spectrum improvement by targeting sleep quality and the stress response.

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