Micardis Prophylaxis Should Have Only Limited Patient Population, Cmte. Says
This article was originally published in The Pink Sheet Daily
Executive Summary
High-risk patients intolerant of ramipril need an alternative to the angiotensin-converting enzyme inhibitor, FDA's cardio-renal advisory committee concludes.
You may also be interested in...
FDA, Boehringer Disagree On Non-Inferiority Margin For Micardis Prophylaxis
Agency will tell advisory committee that non-inferiority analysis should account for improvements in standard of care that change effect size.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.