Drugs

Clinical Hold Lifted on GH Research Antidepressant

FDA has lifted a clinical hold against GH Research’s investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing plans for a global late-stage development program. The action allows the clinical-stage biotechnology company to resume U.S. trials under its IND and aligns development of GH001 across major regulatory jurisdictions, the company says.

Company CEO Velichka Valcheva says GH001 is being positioned as a potential ultra-rapid and durable treatment for patients with treatment-resistant depression. The company expects to initiate a global pivotal Phase 3 program in 2026 and plans to meet with FDA to align on trial design, he adds.

GH001 is the lead candidate of GH Research PLC, which is developing mebufotenin-based therapies for depression. The drug is administered through a proprietary inhalation approach, the company says.

Previously reported results from a Phase 2b trial showed that the drug met its primary endpoint. The company had reported that more than half of treated patients achieved remission by Day 8, rising to 73% at six months with infrequent dosing. According to the company, GH001’s effects were accompanied by a short psychoactive experience, with a median duration of about 11 minutes, and did not require adjunct psychotherapy. Nearly all patients were deemed ready for discharge within an hour of dosing, and no serious treatment-related adverse events were reported, it adds.

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