Home » FDA » Page 10

Tag Archives: FDA

Progress Report: New Antibacterials In the Fight against MDR Bacteria

Posted on by — No Comments ↓

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria→

Solithromycin CAP Study:  Cap the Details (in the Publication)

Posted on by — No Comments ↓

In a recent publication, the results of a large Phase 3 trial comparing solithromycin with moxifloxacin in the treatment of CAP are presented [1]. As this was a global registration trial, we should refer to the indication as CABP, the current FDA acronym for a very defined entity which has some Continue reading Solithromycin CAP Study:  Cap the Details (in the Publication)→

The Cresemba Candidemia Gamble – Rien Ne Va Plus

Posted on by — 1 Comment ↓

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→