Home » CABP » Page 5

Tag Archives: CABP

Commenting on Comments:  The Ceftaroline Trial Program in CABP

Posted on by — No Comments ↓

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→

Why Some Did Not Make It

Posted on by — No Comments ↓

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→