Biologics

Genentech BLA for Wet AMD Implant Submitted

FDA has accepted for priority review a Genentech BLA for its Port Delivery System with ranibizumab (PDS) for treating wet, or neovascular, age-related macular degeneration (AMD). Wet AMD is a leading cause of blindness for people aged 60 and over and affects about 1.1 million people in the U.S., according to the company. Ranibizumab, which is the active ingredient in the company’s Lucentis, is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels, Genentech says.

If approved, PDS would be a first-of-its-kind therapeutic approach, and offer an alternative to frequent eye injections, the company says. The permanent refillable eye implant is about the size of a grain of rice that is designed to continuously deliver a customized formulation of ranibizumab over several months, it says.

The submission is based on positive results from the Phase 3 Archway study, which showed that those being treated with PDS, more than 98% were able to go six months without needing additional treatment prior to the refill exchange, Genentech says. Study patients also achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections.

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