Biologics

Janssen Covid Vaccine Trial Paused Over Unexplained Illness

Johnson & Johnson says it has temporarily paused all dosing in its Janssen Covid-19 vaccine candidate clinical trials due to an “unexplained illness” in a study participant. The illness is being reviewed and evaluated by the Phase 3 ENSEMBLE trial’s independent data safety monitoring board and the company’s clinical and safety physicians, it says. At this stage in the evaluation of the adverse event, Johnson & Johnson indicated that FDA has not issued any clinical hold.

Meanwhile, a clinical hold imposed in September on an AstraZeneca investigational Covid vaccine is ongoing. The University of Oxford, AstraZeneca’s partner in the vaccine, has said a patient’s neurological problem that was detected was likely not related to the vaccine. It also said clinical trials have resumed in the UK, Brazil, and South Africa, while the hold remains in effect in the U.S. Many believe that the continuing hold may signal that U.S. regulators have ongoing safety concerns.

Last week, CBER director Peter Marks was asked about the clinical hold (see earlier story). In responding to the question but not directly addressing AstraZeneca’s specific circumstances, Marks noted that FDA could deploy the rarely-used “commissioner’s finding” to disclose Covid-19 vaccine safety information if such information is not provided by a vaccine manufacturer. He emphasized that he was talking in general terms and not about any specific company. “We very rarely, when we are very concerned about a sponsor not being adequately transparent, can have things like a commissioner’s finding where we can make known safety information that would normally be kept secret under an investigational new drug application,” he said. “But I would really hope we don’t have to get to those kinds of places here.”

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