Drugs

NIH Covid-19 Panel Refutes FDA Plasma EUA

An NIH Covid-19 treatment guideline panel has refuted FDA’s recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treating of hospitalized patients with Covid-19. The panel 9/1 reviewed available evidence from published and unpublished data on convalescent plasma, including the FDA analyses that supported the EUA.

“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” finds the panel. FDA’s data analysis on a subset of hospitalized patients from the Mayo Clinic’s Expanded Access Program compared outcomes in patients who received convalescent plasma with high titers to those who received plasma with low titers and found no difference in seven-day survival overall, it says.

The panel determined that there are “insufficient data to recommend either for or against the use of convalescent plasma.... Convalescent plasma should not be considered standard of care for the treatment of patients with Covid-19.” It also recommended that randomized trials are needed to determine whether convalescent plasma is effective and safe.

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