Galvus Safety Trial Reconsidered In Light Of Novartis Cost Concerns
Novartis' NDA for its oral type 2 diabetes drug Galvus (vildagliptin) will remain in a holding pattern in the U.S. until the firm has a clearer idea of whether it can gain FDA approval without excessive expenditures to gather additional safety data
More from Archive
More from Pink Sheet
European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.
Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.