Drugs

Abivax Positive Data with Ulcerative Colitis Drug

Abivax is announcing new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements across all efficacy endpoints in patients with moderately to severely active ulcerative colitis — including those who had previously failed multiple advanced therapies.

The results, presented at the United European Gastroenterology Meeting in Berlin, come from the eight-week induction phase of the ABTECT-1 and ABTECT-2 trials, which together enrolled 1,272 participants. About 47% of patients had an inadequate response to prior advanced therapy, including biologics, JAK inhibitors, and S1P modulators.

In the pooled analysis, once-daily obefazimod 50 mg showed statistically significant and clinically meaningful improvements in clinical remission and response, regardless of prior treatment history, according to the company. In those with four or more prior therapy failures, the difference was 29%, and among participants with prior JAK inhibitor failure, obefazimod achieved a 34% placebo-adjusted difference, it adds.

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