Drugs

FDA Lifts Hold on Inhibikase Parkinson’s Trial

FDA has lifted its 11/2022 full clinical hold on the clinical trial of Inhibikase Therapeutics’ Phase 2a IkT 148-009 trial in Parkinson’s disease. The company’s multiple systems atrophy program using 148-009 remains under a hold.

The company says IkT-148009 is a c-Abl tyrosine kinase inhibitor that has been shown to halt disease progression, protect and restore lost neurons, and clear the underlying protein pathology in animal studies that suggest a causal link to the initiation and progression of disease in humans.

Inhibikase says the FDA decision to lift the hold on the Parkinson’s program was based on the company’s response and commitments made regarding ophthalmologic monitoring in the study and modifications to the investigator brochure.

FDA asked the company to measure the safety and steady-state pharmacokinetic profile of the 200 mg dose in six healthy people before administration of that dose in Parkinson’s patients. The agency also asked for the measurement of visual acuity and examination of the cornea and lens to complement the analysis of retina, macula, and fundus that was already part of the ocular monitoring program in the trial that was under hold.

Inhibikase says it plans to ask FDA to lift the hold on the multiple systems atrophy program.

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