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Commenting on Comments:  The Ceftaroline Trial Program in CABP

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The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary endpoint.  FDA made other significant changes to the old 1998 Continue reading Commenting on Comments:  The Ceftaroline Trial Program in CABP→

A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

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The treatment history of N. gonorrhoeae makes for fascinating reading.  This organism has always been able to keep the upper hand in the war of bug versus drug.  Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially become resistant in the matter of a decade to every Continue reading A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study→

Why Some Did Not Make It

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There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It→