Off-Label Use Of Malaria Drug Drives FDA To Impose REMS
This article was originally published in The Pink Sheet Daily
Quinine, an old-line malaria drug, has been used off-label for night-time leg cramps, sometimes leading to serious side effects, FDA says.
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Cholesterol Endpoints Draw Scrutiny At HoFH Panels
The Metabolic and Endocrinologic Advisory Committee accepts LDL lowering as endpoint for homozygous hypercholesterolemia drugs, backing approval of Aegerion’s lomitapide by 13-2 and Genzyme’s mipomersen by 9-6, but hones in on the need for better surrogates for cardiovascular morbidity and mortality.
"Bad CME" Program May Be Developed By FDA
Agency asks physicians to report instances of off-label promotion made during continuing medical education classes.
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.