R&D News In Brief: Otezla Disappoints But Dupilumab Doesn’t, Astellas Files Antifungal And NovoSeven Adds Indication
POSTURE study will continue unchanged for Celgene’s PDE-4 inhibitor due to meaningful efficacy seen in a pre-specified subgroup with early-stage disease. Astellas submits an NDA for broad-spectrum antifungal isavuconazole in invasive aspergillosis and invasive mucormycosis. Other drug development news, in brief …
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Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.