Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The FDA web site usually provides label and review documents for approved drugs.[1] Emblaveo, the combination of aztreonam and avibactam, was approved in February 2025, almost ½ year ago, but clinical review documents are still not posted at the site.[2] Hence, we do not know how Regulators felt about the Continue reading An Intro to Emblaveo (aztreonam + avibactam)
Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment. This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary endpoint was a non-standard composite efficacy and safety endpoint that Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,
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?