Flexible 'Menu' Of Antibacterial Development Options Suggested By US FDA Panel
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.
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Antibiotics With Bacteria-Specific, Rather Than Site-Specific, Indication Headed To US FDA
Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.
Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews
The latest drug development news and highlights from our US FDA Performance Tracker.
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.