Biologics

FDA Backs New Covid Vaccine with XBB Variant

FDA reviewers are recommending that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant, which is currently the predominant strain in the U.S. In a just-posted briefing document released in advance of a 6/15 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the reviewers say that the “current sublineages under consideration include XBB.1.5, XBB.1.16, or XBB.2.3… Other factors to inform decision making to be discussed at the VRBPAC meeting include virus surveillance and genomic analyses, antigenic characterization of viruses, human serology studies from current vaccines, and manufacturing timelines.”

FDA says that in addition to considering the Covid-19 vaccine strain composition for the upcoming vaccination period, panel members will be asked to discuss the “available data on the circulation of SARS- CoV-2 virus variants, current vaccine effectiveness and clinical immunogenicity data of current vaccines against recently circulating viruses, the antigenic characterization of circulating virus variants, and pre-clinical immunogenicity data generated by new candidate vaccines expressing or containing updated spike components.”

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