Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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 well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA
Solomkin et al. conclude that the efficacy and safety of eravacycline compares favorably to the control drug, ertapenem.[1] This top-level assessment is made with the usual caveats (insufficient statistical power, small sample size), but a few points deserve comment. Eravacycline is a fluorocycline; as a tetracycline derivative it follows into Continue reading Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study
There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, and how this all matters in clinical practice, on the Continue reading What is the “Niche” for Ceftolozane / Tazobactam?