Drugs

Reps Want FDA Valley Fever Workshop

Rep. Kevin McCarthy (R-CA) and David Schweikert (R-AZ) are asking FDA to hold public workshops on the development of Valley Fever diagnostics, drugs, and biologics to inform the development of a guidance to help with approval of these and related products. In their letter, the two write that Coccidioidomycosis, also known as Valley Fever, is caused by inhaling the spores of a fungus found in soil in the American southwest and Pacific northwest, with reported cases on the rise recently in Arizona and California.

“This fungal disease typically presents flu-like symptoms, but can spread to other parts of the body and become life-threatening,” the letter says. “While the scientific community has made important advances in recent years, treatments are limited and there is currently no FDA-approved cure or vaccine.”

The representatives reference their Finding Orphan-Disease Remedies with Antifungal Research and Development legislation (H.R. 2858) that, among other provisions, directs FDA to hold public workshops and initiate the guidance process for the development of antifungal therapies and vaccines for Valley Fever.

“We were pleased to see in FDA’s 10/9/19 correspondence regarding the Tropical Disease Priority Review Voucher program that FDA is planning on holding a public workshop on the development of therapies to treat Valley Fever, including a discussion on trial designs, endpoints, and patient populations,” the letter says…. “Please keep us informed when the FDA Valley Fever workshops are scheduled.”

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