Biologics

Put T-Cell Assessment in Covid-19 Vaccine Trials: Scientists

A 4/21 letter signed by 69 experts working in academic centers, companies, and non-profit organizations is urging FDA to include a recommendation for T-cell assessment in its guidance to vaccine developers for Covid-19 vaccine trials. The letter says that “measuring T-cell responses in addition to antibodies is critical to help better evaluate vaccine efficacy and inform decisions regarding ongoing protection against current and future variants.”

The scientists say the limited study to date of T-cells in SARS-CoV-2 research “is impeding our ability to inform policies related to emerging variants and long-term immune protection after antibody titers have appropriately declined following infection and/or vaccination….. If thorough data had been collected on the broader adaptive immune response, including antibodies and T-cells, since the beginning of the Covid-19 pandemic, we would better understand the risks posed by the emerging variants and could more readily provide swift messaging to counter misinformation and associated vaccine hesitancy.”

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