Biologics

FDA Gives Humacyte a Regenerative Medicine Designation

FDA has granted Humacyte a Regenerative Medicine Advanced Therapy (RMAT) designation for the company’s investigational human acellular vessel Humacyl. The designation was created under the 21^st Century Cures Act to help speed development of a regenerative medicine therapy (e.g., cell therapy, therapeutic tissue engineering product, human cell and tissue product, or a combination product using such therapies or products).

The RMAT designation makes a product eligible for the same actions as drugs that receive breakthrough therapy designation, including timely advice and interactive communications with FDA. A product designated as an RMAT also may be eligible for other FDA expedited programs, such as Priority Review.

The company says Humacyl has the potential to address unmet medical needs for hemodialysis patients by decreasing vascular access complications. Humacyte is currently undertaking a Phase 3 clinical trial of Humacyl compared to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement.

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