Drugs

BMS, J&J Halt Phase 3 Librexia Trial After Futility Review

Bristol Myers Squibb (BMS) and Johnson & Johnson have stopped their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an independent monitoring committee concluded the study was unlikely to meet its primary endpoint. The decision followed a planned interim analysis by the monitoring committee, which found the drug, added to standard antiplatelet therapy, was unlikely to show a reduction in major adverse cardiovascular events in patients who had recently experienced an acute coronary syndrome (ACS), according to a BMS release. No new safety issues were identified, and the safety profile remained consistent with earlier trials.

The two companies said the decision affects only the ACS study. Two other late-stage milvexian trials — Librexia AF, for atrial fibrillation, and Librexia STROKE, for secondary stroke prevention — will continue as planned, with topline results expected in 2026.

Despite the setback, BMS reiterated its confidence in milvexian, a first-in-class oral factor XIa inhibitor meant to prevent harmful clotting while minimizing bleeding risk. “We remain confident in the potential of milvexian to redefine anticoagulant therapy,” said company drug development vice president Roland Chen. He noted that the AF and stroke-prevention studies differ substantially from the ACS trial in patient population, background therapy, endpoints, and disease biology.

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