Drugs

NCI Head Sharpless Appointed FDA Acting Commissioner

HHS secretary Alex M. Azar III has appointed National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlieb leaves next month. Gottlieb announced his resignation to spend more time with his family (see earlier story).

Sharpless previously served as director of the University of North Carolina Lineberger Comprehensive Cancer Center and was a practicing oncologist specializing in leukemia. Additionally, his research focus has been on the roll the cell cycle plays in cancer and aging. He has authored more than 100 research papers, is an inventor with 10 patents, and is a member of the nation’s oldest honor society for physician-scientists, the American Society of Clinical Investigation. Additionally, he has cofounded two clinical-stage biotechnology companies: G1 Therapeutics and HealthSpan Diagnostics.

Sharpless was sworn in at NCI 10/2017. He is also currently the chief of the Aging Biology and Cancer Section in the National Institute on Aging’s Laboratory of Genetics and Genomics, where he continues his research on the biology of the aging process that promotes the conversion of normal self-renewing cells into dysfunctional cancer cells.

Sharpless was a Morehead Scholar at UNC-Chapel Hill and received his undergraduate degree in mathematics. He obtained his medical degree from the UNC School of Medicine in 1993.

After the Sharpless announcement became official, Gottlieb tweeted “Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”

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