Drugs

PharmaTher to Work with FDA on Ketamine Phase 3 Study

PharmaTher says topline results from a dose-finding and tolerability clinical study of ketamine for treating levodopa-induced dyskinesia (LID) in Parkinson’s patients were sufficient for the company to engage FDA to establish next steps for a planned Phase 3 study to allow for ketamine’s approval under the 505(b)(2) regulatory pathway. A company statement says it will use its proprietary intravenous product Ketarx for the planned Phase 3 study.

The study evaluated the safety, tolerability, and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s disease. PharmaTher reports that 100% of patients treated with ketamine demonstrated a reduction in dyskinesias. Ketamine was well tolerated with no serious adverse events reported, it says.

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