OTC-To-Rx Switch: Barrier Expects Zimycan Trial Data To Boost NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Barrier Therapeutics expects to amend Zimycan NDA with Phase III study in Candida-associated diaper dermatitis by year-end. Firm hopes to revive Johnson & Johnson’s attempted OTC topical antifungal as sole prescription option.
You may also be interested in...
Zimycan "Not Approvable" Letter Could Mean One-Year Delay In Approval
FDA's concerns stem from Barrier Therapeutics' use of a different grade of petrolatum in the absorption study than in clinical trials for the diaper dermatitis agent. The firm says conducting an additional study would take two to four months, plus six months for an agency review.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.