Drugs

J&J sBLA for Tremfya in Ulcerative Colitis

Johnson & Johnson has filed a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). The submission is based on data from the Phase 3 QUASAR program in patients who had an inadequate response or intolerance to conventional therapy, prior biologics or JAK inhibitors, the company says. “The data show statistically significant and clinically meaningful improvements in symptoms, patient-reported outcomes such as fatigue and measures of disease activity including high bar endpoints such as endoscopic and histologic remission,” it says. “The safety results were consistent with the known safety profile of Tremfya in approved indications.”

Tremfya is described as a dual-acting interleukin (IL)-23i that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. “IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC,” the company says. Tremfya was originally approved in 2017 for treating adult patients with moderate-to-severe plaque psoriasis.

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