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Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity

 
• By Bridget Silverman

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.

3D illustration of Clostridium difficile bacteria. Bacteria which cause pseudomembraneous colitis and are associated with nosocomial antibiotic resistance

FDA's push to define a regulatory pathway that will encourage development of drugs for single pathogens could be good news for the handful of companies betting on the approach.

The agency is considering a flexible approach to single-species antibiotic development, in line with the agency's flexible position on orphan drugs. A recent advisory committee discussion looked at a wide menu of options, but disagreement on issues including non-inferiority design and animal models illustrate the challenges ahead

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• By Alaric DeArment

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