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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 Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria
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 Continue reading Solithromycin CAP Study: Cap the Details (in the Publication)
A recent letter to the Editor by Simkins et al. is worth reviewing [1]. The authors describe the complicated course of a patient who suffered graft rejection after liver transplantation, received broad-spectrum antibiotics during prolonged hospitalization and eventually had a Continue reading IV Fosfomycin To The Rescue – And To a Place Near You
In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums. Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA