Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity
Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.
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A setback for Actelion – and Johnson & Johnson – as it reports mixed Phase III data for the Clostridium difficile treatment candidate cadazolid.
FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.