Drugs

Gottlieb Added to FasterCures Board

Former FDA Commissioner Scott Gottlieb has been appointed to the FasterCures advisory board. As a board member, Gottlieb will “leverage decades of experience to provide counsel to the FasterCures team in a variety of areas, including how to best engage patients in research, creating new pathways to innovation through novel financial incentives, and the ways in which a higher-functioning biomedical research system can be advanced,” executive director Tanisha Carino said in an email to FDA Webview.

FasterCures, which is part of the Milken Institute, is “working to build a biomedical research and development system that is effective, efficient, and driven by a clear vision: patient needs above all else,” the group says. “Our programs are focused on enabling patients to more easily participate in medical research, creating better pathways to medical innovation, and advancing a high-performing biomedical R&D system. Our network includes top disease foundations, the philanthropic community, financial institutions, and patient advocates.”

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