The Cresemba Candidemia Gamble – Rien Ne Va Plus

Isavuconazole is a potent triazole; like Voriconazole, it has garnered an indication for invasive aspergillosis. However, it failed where other azole antifungals succeeded: in a pivotal trial, not yet published, the drug was inferior to Caspofungin in the treatment of Continue reading The Cresemba Candidemia Gamble – Rien Ne Va Plus

No Such Thing as a Free Ride…

..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…