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The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)

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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 other efficacy endpoint of interest was missed.  Neither did KB001 Continue reading The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)→

A Renaissance for Old Drugs: Fosfomycin and Colistin

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Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available in Europe for a quite some time but not in the Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin→

Why Did PK/PD Modeling Fail Doripenem in VAP?

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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 together, CAP was not differentiated from HAP, and HAP and Continue reading Why Did PK/PD Modeling Fail Doripenem in VAP?→