Drugs

FDA Funds 2 Natural History Studies

FDA has awarded $4.1 million to fund two new research grants for natural history studies in rare diseases, which are intended to help design efficient clinical trials to test future treatments. Natural history studies examine how specific diseases progress, “through the presymptomatic and clinical stages, to a final outcome in the absence of treatment,” the agency says in a notice. Grants were awarded to:

University of Texas MD Anderson Cancer Center (Houston, TX): $1.7 million over four years
Vanderbilt University Medical Center (Nashville, TN): $2.4 million over four years.

The Texas study seeks to use a multi-institutional registry to “characterize disease variables and patient perspectives that inform decisions regarding initiation of and adherence to chemotherapy in medullary thyroid cancer,” the agency says. And the Vanderbilt study aims to focus on cardiomyopathy, which is the leading cause of death in Duchenne muscular dystrophy. “The study will combine genetic differences with imaging and blood biomarkers to identify surrogate biomarkers that predict the risk of cardiac dysfunction in Duchenne muscular dystrophy and other related diseases,” it says.

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