Drugs

NIH Pauses Lilly Covid Antibody Trial

The National Institutes of Health has paused the ACTIV-3 trial of the Lilly LYCoV555 Covid-19 antibody drug due to an undisclosed safety issue. Endpoints News reports online that the halt comes one week after Lilly said it had applied to FDA for an emergency use authorization (EUA) for the therapy. President Donald Trump has called for quick EUAs for the Lilly product and for a Regeneron antibody therapy that he received while hospitalized.

Lilly said it had paused the trial out of an “abundance of caution” on the recommendation of the independent data safety monitoring board.

The news account says the pause came one day after Johnson & Johnson announced that its Covid-19 vaccine trial was put on hold. AstraZeneca, another vaccine candidate manufacturer, is awaiting permission to restart the trial of its vaccine after a one-month safety issue pause.

Media reports on the actions stress that safety issues and pauses often happen in clinical trials. They can be due to a variety of causes and do not necessarily represent a problem with the vaccine or therapy, the reports say.

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