Drugs

Boehringer Schizophrenia Cognition Trial Misses Endpoints

Boehringer Ingelheim says its Phase 3 CONNEX clinical trial program evaluating iclepertin in cognitive impairment in adults with schizophrenia did not meet primary and key secondary endpoints. “Overall, no statistically significant effects on cognition or functioning were observed in patients treated with iclepertin versus placebo at six months,” it says, adding that all three trials demonstrated that iclepertin was generally well tolerated, with a safety profile consistent with previous studies.

Boehringer says schizophrenia affects about 24 million people worldwide and cognitive impairment affects more than 80% of these people. It notes that there are no approved targeted pharmaceutical treatments for cognitive impairment in schizophrenia.

Iclepertin is described as an investigational oral inhibitor of glycine transporter 1. The CONNEX clinical program enrolled 1,840 patients in 41 countries, and Boehringer Ingelheim says it decided to discontinue the long-term extension trial, CONNEX-X, effective immediately.

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