Drugs

Viamet Pharma Gains Orphan Status for Valley Fever Drug

FDA has granted Viamet Pharmaceuticals an orphan drug designation for VT-1598 for treating coccidioidomycosis (also known as Valley Fever). VT-1598 is a selective, orally available inhibitor of fungal CYP51 that the company says has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for Valley Fever. The lung infection common in the southwestern U.S. affects about 150,000 people in the U.S. annually. “While current therapies are effective in some patients, they are often poorly tolerated and morbidity and mortality remain significant,” the company says.

In preclinical studies, VT-1598 demonstrated significantly greater potency against Coccidioides clinical isolates than fluconazole, an antifungal therapy commonly used as the primary treatment for Valley Fever, Viamet says. “In preclinical models, the therapy was also found to be highly effective in treating disease localized to the central nervous system, the most difficult to treat site of dissemination in humans.”

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