Drugs

Hold Lifted on INmune Alzheimer’s Trial

FDA has lifted a 2022-imposed clinical hold against INmune Bio’s XPro (XPro1595; pegipanermin) and its Alzheimer’s disease clinical trial. “The Phase 2 trial is on track to enroll the last patient mid-2024,” the company says, adding that top line data is expected about six months after the last patient is enrolled.

“Our primary goal is to complete the Phase 2 program in 2024 followed by an end-of-Phase 2 meeting with the FDA in early 2025 to confirm our planned global Phase 3 trial that will include sites in the U.S., Canada, U.K., EU and Pacific rim,” INmune says.

XPro 1595 is described as a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF without affecting trans-membrane TNF or TNF receptors. The company says the hold was related to an agency request for additional chemistry manufacturing and controls information. While on clinical hold, the Phase 2 trial remained open in Australia and continued to enroll patients. “XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation,” the company says.

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