23 A combination of these data with a meta-analysis 3 reviewing rosiglitazone use, which showed a 43% increase in the rate of myocardial infarction (p=0.003) and a 64% nonsignificant increased risk of CV death (p=0.006) in patients using the drug, ultimately compelled the FDA to take immediate action toward changing the standard requirements for documenting safety of new medications seeking approval for T2DM treatment
PMCID: PMC3564000
"R&D is a cross-border global gamegreat innovation and science, wherever it is conducted, is valuable," says Reicin, who pointed to the international nature of discovery and production in the GLP-1 market
The data examined in this report show that most commercial patients face significant hurdles: large denial rates (often two-thirds of requests), multi-day delays (median ~6 days if not instant-approve), and high first-fill abandonment (fill rates commonly 60%)
Competition is fierce, and there are a lot of manufacturers of all sizes around the world in the game, from really huge ones (Teva, Dr
