Tag Archives: Ketek

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→

Omissions – Commissions – Errors – Blunders – Solithromycin

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Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things about the drug. It also highlighted how strategic missteps can Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin→

Profiling Solithromycin: FDA AMDAC on Solithera

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Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for the next new B-lactam or quinolone regardless of whether during Continue reading Profiling Solithromycin: FDA AMDAC on Solithera→