Drugs

FDA Lifts 3 Seladelpar Clinical Holds

FDA has lifted its clinical holds on CymaBay Therapeutics’ seladelpar for its three IND applications for nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis. The company says it stopped all seladelpar clinical trials 11/25/19 after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end of treatment biopsy review of a 52-week Phase 2 NASH study.

An expert panel found no clinical, biochemical, or histological evidence of seladelpar-related liver injury in the NASH study and unanimously supported reinitiating clinical development of the drug pending FDA approval, the company says.

CymaBay says it will first reinitiate clinical development in a Phase 3 PBC trial.

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