Drugs

Trump’s Covid-19 Drug Shows No Benefit: Study

A new study shows that the malaria drug hydroxychloroquine, which has been touted by president Trump and his allies for treating coronavirus patients, did not reduce the risk of mechanical ventilation in patients hospitalized with the infection. The study was conducted in all U.S. Veterans Health Administration medical centers until 4/11. The two primary outcomes were death and the need for mechanical ventilation.

According to the study, an increase in overall mortality was also identified in patients treated with hydroxychloroquine alone. “These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs,” the study says. Rates of death in the hydroxychloroquine, hydroxychloroquine plus azithromycin, and no hydroxychloroquine groups were 27.8%, 22.1%, 11.4%, respectively.

The study was posted on an online site for researchers and has not been peer reviewed yet. It was funded by grants from the National Institutes of Health and the University of Virginia.

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