Meiji Seika Pharma wins EU orphan drug status for morcamilast in palmoplantar pustulosis
EU orphan status for morcamilast in PPP reshapes Meiji Seika Pharma’s European strategy. See what it means for PDE4 competition and rare dermatology.
Novo Nordisk secures EU nod for higher Wegovy dose amid intensifying GLP-1 competition
EU approves 7.2 mg Wegovy for obesity. Explore what this means for efficacy, competition and reimbursement across Europe.
Can EU-backed CDMO projects redefine pharma supply chains in post-industrial Europe?
The European Commission’s recent approval of €47 million in German state aid for Vetter Pharma’s new aseptic filling facility in Saarlouis marks more than a regional win. It signals a structural shift in how Europe views contract manufacturing organizations, or CDMOs—not merely as outsourcing vendors, but as core pillars of supply chain resilience, regional economic […]
Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]