Drugs

Recognify Reports Mixed Data on Schizophrenia Drug

Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated with schizophrenia (CIAS), did not meet its primary efficacy endpoint, though it did show encouraging signals of cognitive benefit and reaffirmed the drug's strong safety profile.

The six-week, placebo-controlled trial enrolled 242 subjects across the U.S. and Europe to evaluate two doses of inidascamine. While the drug did not achieve statistical significance on the primary endpoint, improvement on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery score, it did show numerical improvements in key cognitive scores including symbol coding, processing speed, and verbal memory, Recognify says.

Inidascamine is described by the company as an oral compound that modulates cholinergic, glutamatergic, and GABA-B systems to potentially improve cognitive function. It has been studied in over 600 participants across 10 trials, with prior data suggesting benefits in verbal learning, memory, and processing speed. The company adds that it is currently analyzing secondary endpoints and subgroup data to better understand the results and identify potential responder populations. Full data will be presented at future scientific meetings, with decisions on the program’s next steps to follow.

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