BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

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 Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

Gepotidacin ABSSSI – How to Fail Adaptively

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 Continue reading Gepotidacin ABSSSI – How to Fail Adaptively

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

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

The Letermovir Top-Line Results are Out – Or Are They?

Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to Continue reading The Letermovir Top-Line Results are Out – Or Are They?

GC Therapy –  Shooting for the Stars

Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead Continue reading GC Therapy –  Shooting for the Stars