Drugs

FDA Lifts Partial Clinical Hold on Alzheimer’s Drug

FDA has removed a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human triggering receptor expressed on myeloid cells 2 (TREM2) agonist for treating common neurodegenerative diseases associated with microglial dysfunction, particularly Alzheimer’s disease. The decision to lift the hold follows a company-submitted complete response to agency concerns raised 9/2023 that limited the maximum exposure of VG-3927 in healthy volunteers in the Phase 1 clinical trial

In July, the company said recent interim data from the ongoing clinical trial that showed a safety and tolerability profile supporting VG-3927’s continued clinical development. “In addition,” it said, “VG-3927 demonstrated a predictable PK profile supportive of once-daily dosing. Importantly, VG-3927 achieved a robust and sustained decrease of soluble TREM2 in the CSF [cerebrospinal fluid] demonstrating clinical proof-of-target engagement.”

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

Read more

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