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Latest From Scynexis, Inc.

Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

Rare Diseases Review Pathway

Antifungal Drug Sponsors Seek Clearer Regulatory Pathway, Less Burdensome Trials

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

Clinical Trials Rare Diseases

Scynexis Prepares For NDA Filing With Second Phase III Success In VVC

Novel antifungal ibrexafungerp, a first-in-class triterpenoid, demonstrates ability to clear vulvovaginal candidiasis infections in second pivotal study; firm also looks to demonstrate efficacy in recurrent infections.

Clinical Trials Drug Approval Standards

Cormedix Leads Limited Pipeline For US FDA’s LPAD Pathway

Cormedix prepares NDA submission for Neutrolin for prevention of catheter-related blood stream infections, aiming to become the third approval under the US FDA’s Limited Population Pathway.

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