Drugs

Hansa Biopharma’s Imlifidase Hits Primary Endpoint

Hansa Biopharma says investigational imlifidase met the primary endpoint in a pivotal Phase 3 study in highly sensitized kidney transplant patients, setting up a potential U.S. regulatory filing later this year. The U.S.-based ConfIdeS trial enrolled adults with a calculated panel reactive antibody level of 99.9% or higher — patients considered among the hardest to match for kidney transplants. At 12 months, patients treated with imlifidase achieved a mean estimated glomerular filtration rate of 51.5 mL/min/1.73m² compared with 19.3 mL/min/1.73m² in the control group, according to the company. The 32.2 mL difference was both statistically significant and clinically meaningful, it adds.

Additionally, Hansa says imlifidase was also associated with a higher rate of dialysis independence at 12 months. Safety results were consistent with previous studies, with no unexpected findings, it says.

Based on the data, Hansa plans to submit a BLA under the accelerated approval pathway by the end of 2025.

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