Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
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…