Drugs

Clinical Hold on LogicBio Gene Therapy

FDA has placed a clinical hold on LogicBio Therapeutics’ Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia (MMA). According to the company, four patients have been dosed in the SUNRISE trial with LB-001, a single-administration, adeno-associated virus (AAV) genome editing therapy. One patient reportedly experienced a drug-related serious adverse event (thrombotic microangiopathy (TMA)), which it says has been previously reported in association with other AAV genetic therapies. “The patient was hospitalized and responded well to intravenous fluids and parenteral nutrition,” LogiBio says.

The company says it subsequently implemented additional safety measures in the SUNRISE trial, and reported it to FDA and the trial’s Data Safety Monitoring Board (DSMB). Last month, another patient dosed in the SUNRISE trial experienced a case of TMA. After this report, the agency notified the company that the SUNRISE trial has been placed on clinical hold. “LogicBio will be working closely with the FDA and the DSMB to determine the next steps for the SUNRISE trial and the LB-001 program,” 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