Biologics

GSK Wins Priority Review for Expanded Use of RSV Vaccine

FDA has accepted for priority review a GSK supplemental BLA to extend the indication of its Arexvy adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. The vaccine is currently approved for adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV. The agency has set a user fee review action target date of 6/7.

The application is based on data from a Phase 3 trial [NCT05590403] that evaluated the non-inferiority of the immune response in participants aged 50 to 59 at increased risk of RSV-LRTD compared to older adults aged 60 years and above after a single vaccine dose, according to the company. “The trial’s primary endpoints were RSV-A and RSV-B neutralization titres of both groups of 50 to 59 year olds at one month after the vaccine administration compared to adults aged 60 and older,” it says, adding that there were also safety and immunogenicity secondary and tertiary endpoints. GSK plans to present the trial results at an upcoming medical conference.

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