FDA Panel Backs Approval Of Orexigen's Obesity Drug Contrave
This article was originally published in The Pink Sheet Daily
Promised post-market randomized clinical trial to assess cardiovascular risk tips the panel in favor of the naltrexone/bupropion combination.
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Timing of the study to be discussed at Dec. 7 advisory committee meeting.
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.