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BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

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GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development.  Several antibiotics are listed on their website targeting UTI pathogens, and one of them was just approved, namely gepotidacin / Blujepa, a Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1→

Gepotidacin ABSSSI – How to Fail Adaptively,

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Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment.  This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary endpoint was a non-standard composite efficacy and safety endpoint that Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,→

A Critical Review of WHO’s List of Antibacterials in Clinical Development

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WHO compiles a list of antibacterials in clinical development on a regular basis, the last in mid-2024 [1].  The information is up-to-date and detailed: it provides MoA and antibacterial spectrum, coverage of problem pathogens, the development phase, and whether it can be considered an ‘innovative’ drug (based on a set Continue reading A Critical Review of WHO’s List of Antibacterials in Clinical Development→