FDA Alerts Public To Ongoing Safety Review Of Orlistat In GSK, Roche Drugs
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's announcement Aug. 24 that it is reviewing adverse event reports of liver injury related to orlistat - the active ingredient in GlaxoSmithKline's weight-loss product alli could threaten the drug's already slipping sales.
You may also be interested in...
Obesity Drug Developers Aim To Navigate Regulatory Backroads
The major lesson of FDA’s serial rejection of three obesity drugs in a six-month span is that safety is paramount in the weight loss space. That’s agreed. But beyond that, it’s tough to know what to expect, and obesity drug developers face an uncertain regulatory path going forward.
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.