Allphase Pharma Consulting, LLC
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On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’. As a QIDP drug, Avycaz received priority review. Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions
Despite all the concern about the emergence of CRE pathogens worldwide, it is quite difficult to obtain hard quantitative, prospectively collected incidence figures. A recent article by Robert [1] and colleagues provides useful data from France. Using a practical definition of carbapenem-non-susceptibility (ertapenem > 0.5, imipenem, meropenem > 2, doripenem > 1), Continue reading CRE Surveillance Data from France
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