Biologics

6 Reps Want FDA Voucher for Valley Fever

Six House members from California and Arizona, five Republicans and one Democrat, are asking FDA commissioner Robert Califf to “reconsider expediently the addition of coccidioidomycosis, also known as Valley Fever, to the current list of tropical diseases that qualify for a priority review voucher as directed in House Report 117-392.” In a 3/6 letter, the six say there are about 200 deaths a year from the fungal infection that is endemic to discrete areas of the American southwest.

“From our understanding,” the representatives write, “FDA should be able to qualify Valley Fever as part of the tropical disease priority review voucher program due to it being an ‘infectious disease for which there is no significant market in developed nations and [it] disproportionately affects poor and marginalized populations.’…It is our understanding the Valley Fever prevalence in the United States is below the threshold set by FDA for this program, which indicates a lack of a significant market to support the development of treatments and a vaccine, and disproportionately impacts marginalized populations according to data collected by the Centers for Disease Control and other public health organizations.”

The lawmakers write that in light of the current standard of care, there is a critical need for improved products. “We believe that an incentive in the form of a voucher would provide necessary interest and investment,” they conclude.

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