Biologics

FDA Reviewers Back Janssen Covid-19 Authorization

FDA reviewers are backing an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of a 2/26 advisory committee meeting discussing the vaccine’s EUA request, agency reviewers determined that the vaccine “met the prespecified success criteria” in the pivotal trial.

Vaccine efficacy against moderate to severe/critical Covid-19 across all geographic areas in which the trial was conducted was 66.9% in cases occurring at least 14 days after the single-dose vaccination and 66.1% in cases occurring at least 28 days after vaccination, the briefing document said. A secondary endpoint analysis found vaccine efficacy of 76.7% and 85.4% against severe/critical Covid-19 occurring at least 14 days and 28 days, respectively. “In a post hoc analysis of all Covid-19 related hospitalizations starting 14 days after vaccination, including non-centrally confirmed cases, there were two cases in the vaccine group (with no cases after 28 days) compared with 29 cases in the placebo group (with 16 cases after 28 days),” it said. As of 2/5, there were seven Covid-related deaths in the study in the placebo group and no such deaths in the vaccine group.

The reviewers also said the company’s data “supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.”

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