Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
As many in the field have said before, what we really need are antifungals with a truly novel MoA, not minor changes to well-established classes.[1] There is a shortage of new antifungals for invasive disease. Small improvements in PK will hardly move the field forward or excite investors to engage. Our current Continue reading The Antifungal Landscape – 2
David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”. He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS
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 invasive candidiasis/candidemia in non-neutropenic patients [1]. To provide some background: in Continue reading The Cresemba Candidemia Gamble – Rien Ne Va Plus