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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,→

Is the AOM Indication Making a Come-Back?

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We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue shortly after the 1998 FDA Guidelines were published. The arguments Continue reading Is the AOM Indication Making a Come-Back?→