Biologics

EUA Filed for Covid Prevention in Immunocompromised

Invivyd says it is seeking FDA emergency use authorization for VYD222, which is described as a “broadly neutralizing, half-life extended monoclonal antibody candidate for the pre-exposure prevention of Covid-19 in immunocompromised adults and adolescents.” The submission is based on “positive initial results” from the CANOPY Phase 3 pivotal clinical trial, as well as ongoing in vitro neutralization activity against relevant Covid variants, it says.

Recent results from the CANOPY trial demonstrated that VYD222 produced high serum virus-neutralizing antibody (sVNA) titer levels against XBB.1.5 variant in the immunocompromised cohort, the company says. “Initial results showed that the safety and tolerability profile of VYD222 remained favorable with no study drug-related serious adverse events reported; adverse events attributed to VYD222 were Grade 1 or 2 (mild or moderate) in severity,” it adds.

Invivyd notes that there are more than 9 million immunocompromised people in the U.S. who may not adequately respond to a Covid-19 vaccination, which increases their risk for severe outcomes if infected. It adds that there are no monoclonal antibodies authorized or approved in the U.S. for preventing symptomatic Covid-19.

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