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Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP. Ten Continue reading Sulopenem uUTI – Does It Suffice?
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
FOR PART 1, CLICK HERE Should we assume that the results of this Global Epi Study were the reason why Sanofi became disillusioned about the prospects of KB001? Or was it an internal strategic decision based on portfolio-review where KB001 just Continue reading The Demise of KB001 (Part 2): An Anti-Pseudomonas Antibody Hits the Dust (instead of Paydirt)
In January this year, Kalobios informed investors that KB001-A had failed to meet efficacy criteria in a Phase 2 trial of cystic fibrosis (CF) patients. In this well-controlled well-executed placebo-controlled trial of182 patients, the primary endpoint and just about every Continue reading The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)
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, Continue reading What is the “Niche” for Ceftolozane / Tazobactam?