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Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
When Roche inlicensed Polyphor’s anti-pseudomonas drug POL7080 in November 2013, it marked a turning point. It seemed that Big Pharma that had all but abandoned the field in the last decade and was getting engaged in anti-infectives again. When a Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 1)
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)
When imipenem is dosed at 1 g q8h for serious infections, it is infused over 40-60 min. Its label states that it is indicated for “lower RTI”, an old-fashioned term from the days when bronchitis and pneumonias were still lumped Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?