Drugs

FDA Absent on Cancer Moonshot Leadership Panel

FDA representation is missing from a National Cancer Institute (NCI)-created blue ribbon panel of scientific experts, cancer leaders, and patient advocates that will guide the scientific direction and goals under vice president Joe Biden’s National Cancer Moonshot Initiative. The panel will serve as a working group of the presidentially appointed National Cancer Advisory Board and will provide scientific guidance from thought-leaders in the cancer community, NCI says.

“This Blue Ribbon Panel will ensure that, as NIH allocates new resources through the Moonshot, decisions will be grounded in the best science,” Biden says. “I look forward to working with this panel and many others involved with the Moonshot to make unprecedented improvements in prevention, diagnosis, and treatment of cancer.”

Over the next several months, the panel will decide how to advance the principles outlined under the initiative. These include developing cancer vaccines, highly sensitive approaches to early detection, advances in immunotherapy and combination therapies, single-cell genomic profiling of cancer cells and cells in the tumor microenvironment, enhanced data sharing, and new approaches to pediatric cancer treatment.

To meet its milestones, the panel will begin its work immediately, convening its first meeting in the coming weeks. The panel will also consider public comments over the next several months prior to making its recommendations.

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