Drugs

FDA, Catalyst Agree on Trial Protocol for LEMS Therapy

FDA and Catalyst Pharmaceuticals have reached an agreement under a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach in an upcoming Phase 3 study evaluating Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. Catalyst intends to conduct its second Phase 3 trial (designated as LMS-003) at two clinical trial sites in the U.S. The double-blind, placebo-controlled withdrawal trial will include 28 subjects, and will have the same co-primary endpoints as Catalyst’s first Phase 3 trial evaluating Firdapse, according to the company, adding that it will be a parallel design and not a cross-over design. Additionally, the agency has agreed to allow Catalyst to enroll patients from its expanded access program as study subjects.

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