Pharma Business - September 16, 2026
FDA grants Orphan Drug Designation to OXC-201
Oxcia has been granted Orphan Drug Designation (ODD) by the FDA for OXC-201, its drug candidate for idiopathic pulmonary fibrosis (IPF), just weeks after a similar decision from the EMA.
Agreement - September 15, 2026
Zealand Pharma out-licenses diabetes peptide platform to US biotech Elvinix
Zealand Pharma has signed an exclusive license agreement with newly formed US biopharmaceutical company Elvinix, granting the rights to develop and commercialize a GLP-1/gastrin dual-agonist peptide portfolio as a regenerative therapy for type 1 diabetes.
Pharma Business - September 15, 2026
FDA clears Orexo to begin trial of OX640 for anaphylaxis
The US Food and Drug Administration has approved Orexo's Investigational New Drug application for OX640, a needle-free intranasal powder formulation of adrenaline, allowing the company to begin its pivotal clinical development program for the treatment of anaphylaxis.
Clinical Trials - September 14, 2026
Phase 2a results move ResoTher Pharma toward key efficacy trial
ResoTher Pharma has reported promising Phase 2a results for its cardioprotective drug candidate RTP-026, moving the company a step closer to a key efficacy trial and a potential pharma partnership or sale.
Pharma Business - September 14, 2026
Lundbeck’s asedebart receives US orphan drug designation for Cushing’s syndrome
The US FDA has granted Orphan Drug Designation to Lundbeck's investigational anti-ACTH monoclonal antibody asedebart for the treatment of endogenous Cushing's syndrome, adding to a growing list of rare-disease designations for the candidate across three regions.
Pharma Business - September 14, 2026
Novo Nordisk rebrands to ‘Novo’ and introduces new corporate culture framework
Novo Nordisk has unveiled a rebrand centred on the tagline "Lasting Health Starts Now" and a shortened public-facing name, "Novo," alongside a new set of cultural principles called "The Novo Way" aimed at increasing focus and speed across the organisation.