Drugs

Inhibikase Therapeutics Pulls Plug on Parkinson’s Drug

Inhibikase Therapeutics says it is pausing further development of risvodetinib, a selective inhibitor of the non-receptor Abelson Tyrosine Kinases and its use in untreated Parkinson’s disease. The company says that recent data from its Phase 2 201 trial did not demonstrate an “improvement in the top hierarchical efficacy measure, which was the sum of Parts 2 and 3 of the Movement Disorder Society Universal Parkinson’s Disease Rating Scale” at any dose group (50mg, 100mg or 200mg) versus placebo.

The company noted that the 201 trial met its primary endpoint of safety and tolerability, with 95% of enrolled participants completing 12 weeks on risvodetinib. “Risvodetinib adverse event observations were comparable to placebo in frequency and severity,” it says, adding that there were no treatment-related severe adverse events.

Risvodetinib is described as an oral drug that targets c-Abl, a kinase enzyme that’s involved in Parkinson’s disease. It was intended to prevent the loss of dopamine-producing neurons in the brain and gut, which can help reverse the disease’s effects.

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