Drugs

J&J Kills Nipocalimab Plus Tumor Necrosis Factor in RA

Johnson & Johnson has halted development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis (RA) after a mid-stage proof-of-concept study failed to show added benefit. The Phase 2a DAISY trial tested nipocalimab, an anti-FcRn antibody, alongside a tumor necrosis factor inhibitor in patients with refractory RA — those who had not responded adequately to existing therapies. After 12 weeks, the combination did not demonstrate meaningful improvements compared with anti-TNFα therapy alone, the company says, adding that no new safety signals were reported.

J&J characterized the study as an innovative attempt to expand nipocalimab’s reach into difficult-to-treat RA, but said it will not pursue the combo further. However, the drug remains a key part of J&J’s immunology pipeline, and it is being studied broadly in autoimmune and maternal-fetal medicine, including trials in systemic lupus erythematosus, myasthenia gravis, hemolytic disease of the fetus and newborn, and other antibody-driven conditions. Analysts have projected multi-billion-dollar potential for the therapy, which J&J has previously estimated could exceed $5 billion in peak annual sales.

Earlier this year, FDA approved a J&J BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis. The company described the therapy at the time as an immunoselective therapy designed to “substantially reduce immunoglobulin G (IgG), including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions.”

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