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For the latest QIDP listing, please click HERE Our latest internet search came up with 37 drugs that garnered QIDP status. They are listed in the Table below (if I missed a compound, please leave a comment!!). The table is searchable so you should be able to massage the data to Continue reading Drugs with QIDP Designation – Update 4/8/2015
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