FDA's announcement it is investigating a possible risk of liver injury related to orlistat - the active ingredient in Roche Pharmaceuticals' prescription weight-loss drug Xenical and GlaxoSmithKline's OTC alli - could threaten short-term sales
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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.
