Biologics

AstraZeneca Covid-19 Trial Stops Over Safety Signal

As public confidence wanes on potential Covid-19 vaccines, an AstraZeneca and University of Oxford Phase 3 vaccine study has been put on clinical hold due to a serious adverse reaction in a trial participant in the United Kingdom. It is not determined whether FDA or another regulatory agency ordered the hold or if it was a precautionary and voluntary action by AstraZeneca, according to Stat News.

An AstraZeneca spokesperson said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” Details about the adverse reaction were not shared, although the trial participant is expected to recover, Stat reports.

An individual familiar with the adverse reaction told Stat that it is having an impact on other AstraZeneca vaccine trials underway and clinical trials being conducted by other vaccine manufacturers. Researchers conducting other trials are now combing for similar cases in databases reviewed by data and safety monitoring boards, the individual said.

AstraZeneca began the Phase 3 trial in the U.S. in late August. In total, there are 62 sites across the country, according to the clinicaltrials.gov database.

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