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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→

At Last, The Fairy Tale Becomes Clear…

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If you ever wondered how Snow White could have been poisoned by eating an apple, you probably did not realize how much this tale of folklore was based on cruel reality.  Science has finally caught up with the Brothers Grimm who wrote the fairy tale:  a recent outbreak of listeriosis Continue reading At Last, The Fairy Tale Becomes Clear…→