Drugs

FDA Slaps Hold on Diabetes Investigational Drug

FDA has placed a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin and its use in improving glycemic control in Type 1 diabetes patients. Cadisegliatin is an oral, liver-selective, glucokinase activator that the company says has been well-tolerated in over 500 subjects to date with up to six months of treatment. Selectively acting on the liver, cadisegliatin is said to increase the activity of glucokinase independently from insulin to improve glycemic control.

“The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy,” the company says. “The agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.”

vTv says cadisegliatin demonstrated “compelling efficacy and a favorable safety profile” in previous subjects dosed to date.

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