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I find it useful to look back and review drug candidates that were stopped in development. In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug. More importantly, we want to learn about the Continue reading Discontinued But Not Forgotten: HCV Drugs That Did Not Make It
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
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