Biologics

Inovio Begins Rolling BLA for Rare Throat Disorder

Inovio Pharmaceuticals says it has started a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papillomatosis (RRP), with the goal of securing FDA approval by the end of the year. The company expects to complete the filing in the coming months and plans to request a priority review, which could shorten the review period.

RRP is a rare, often debilitating condition caused primarily by HPV-6 and HPV-11 that leads to wart-like growths in the respiratory tract, according to the company, adding that standard treatment involves repeated surgeries to remove papillomas, which frequently return and carry risks of vocal cord damage and airway obstruction.

INO-3107 is designed to train the immune system to target HPV-infected cells, Inovio says. In a Phase 1/2 study, 72% of patients experienced a 50–100% reduction in the number of surgeries in the first year after treatment, it says, adding that follow-up data from a retrospective study showed that 86% of patients maintained that level of benefit in the second year, with half requiring no surgeries at all. The treatment was generally well tolerated, with most side effects limited to injection site pain and fatigue.

FDA has already granted INO-3107 both orphan drug and breakthrough therapy designations, and it has indicated accelerated approval is an option based on the completed mid-stage trial data, according to the company.

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