Drugs

Petition Wants 2 Cassava Simufilam Trials Halted

An 8/18 petition submitted to FDA by attorney Jordan Thomas (Labaton Sucharow) asks FDA to halt two ongoing Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an agency audit of concerns raised in the petition. The document says Cassava has publicly announced the completion of a successful end-of-Phase-2 meeting with FDA and has said the company and agency are aligned on key elements of a Phase 3 program that will start this month.

“Information available to the petitioner … raises grave concerns about the quality and integrity of the laboratory-based studies surrounding the drug candidate and supporting the claims for its efficacy,” the petition says. “Petitioner is therefore requesting FDA to halt the clinical studies pending a thorough audit of the publications and data relied on by Cassava in support of its claims.”

The petition calls specifically for FDA to audit (1) the publications relied on by Cassava in support of the scientific claims concerning simufilam; (2) the IND application for simufilam’s use in Alzheimer’s disease; and (3) all clinical biomarker studies of simufilam in Alzheimer’s disease. The petition also asks that FDA oversee third-party reanalysis of all clinical biomarker studies of simufilam in Alzheimer’s disease.

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