Tag Archives: FDA Guidance

Progress Report: New Antibacterials In the Fight against MDR Bacteria

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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 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)

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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)→

IV Fosfomycin To The Rescue – And To a Place Near You

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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 bloodstream infection with carbapenem-resistant Klebsiella pneumoniae (CRKP) which was resistant Continue reading IV Fosfomycin To The Rescue – And To a Place Near You→