Drugs

J&J Reports Positive Data on Nipocalimab

Johnson & Johnson is reporting positive data from two studies involving its monoclonal antibody nipocalimab. In the pivotal Phase 3 VIVACITY study, it says nipocalimab met the primary endpoint and achieved a statistically significant reduction in a generalized myasthenia gravis score from baseline over weeks 22 to 24 compared with placebo. Generalized myasthenia gravis (gMG) is a chronic and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.

The company also says the primary endpoint was met in the Phase 2 DAHLIAS dose-ranging study in adults with Sjögren’s disease. That chronic autoimmune disease is “characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glandular systems,” it says, adding that the disease is nine times more common in women than men.

Johnson & Johnson says it plans to present full results from the Phase 3 VIVACITY study at an upcoming scientific medical congress and “engage with global regulatory authorities about bringing nipocalimab to patients living with gMG.” The results from the Phase 2 DAHLIAS study will also be presented at a scientific medical congress later this year, it says, adding that it also supports further research involving the drug.

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