FDA to review isavuconazole

FDA accepted for review an NDA from Astellas Pharma Inc. (Tokyo:4503) for isavuconazole ( BAL8557) to treat invasive aspergillosis and mucormycosis (zygomycosis). The PDUFA date is March 8, 2015. The acceptance triggers a CHF12 million ($12.9 million) milestone payment from Astellas to partner Basilea Pharmaceutica AG (SIX:BSLN). An MAA for the broad-spectrum water-soluble azole antifungal is also under review in the EU, with a decision expected by 4Q15. ...