Biologics

FDA Extends Review of Chikungunya Vaccine

FDA has extended by three months the review of a Valneva BLA for VLA1553, the company’s chikungunya virus vaccine candidate to allow “sufficient time to align and agree on the Phase 4 program necessary under the accelerated approval pathway,” according to the company. No additional clinical data have been requested at this time, it says. A review action is now expected by the end of November.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus transmitted by Aedes mosquitoes. It causes rapid large outbreaks with high attack rates, affecting up to three-quarters of the population in areas where the virus is circulating, according to the company.

Data from the company’s Phase 3 trial was recently published in The Lancet. Data showed that the vaccine demonstrated a “very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration,” the company says. “This immunogenicity profile was similar in both younger and older adults, and 96% of participants maintained seroresponse six months after vaccination. VLA1553 was generally safe and equally well tolerated in younger and older adults.”

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