Drugs

Firm Sues FDA to Reverse Clinical Hold

Regenxbio has filed a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases. The complaint alleges that FDA’s final agency action is “contrary to law and arbitrary and capricious because it did not follow the statute or its own regulations, nor did FDA offer a reasoned explanation for issuing a clinical hold without advance warning.”

The company’s product, RGX-314, is under development for treating wet age-related macular degeneration. “The results of an interim clinical trial for RGX-314 were promising: RGX-314 was well tolerated by all forty-two patients, with patients at the higher doses tested experiencing stable to improved vision on average and an overall reduction in the need for alternative treatments to halt the course of the disease,” the complaint says. On 10/18, FDA placed RGX-314 on clinical hold without any explanation, the company contends.

Regenxbio is seeking a declaration, order, and judgment to reverse the clinical hold.

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