Shionogi is hoping to demonstrate the efficacy of its oral COVID-19 candidate Xocova through an appropriate primary endpoint in its Phase III trial, while the Japanese firm is also eyeing global expansion for the drug should a world-first domestic approval be granted.

The biopharma industry broke records again in 2021 with the amount of money raised for drug development. After a year of rapid growth, what will 2022 bring for market dynamics and R&D catalysts in biopharma?

The European Medicines Agency had a busy time at its meeting last week. It gave the green light to 11 products, four of which are for rare diseases including ANCA-associated vasculitis, and to a range of treatments for conditions as diverse as non-small cell lung cancer, smallpox, migraine, COPD, COVID-19 and obesity.

The sponsors of aducanumab and three other drugs are set to explain why their EU marketing authorization applications merit approval during oral explanation meetings at the European Medicines Agency.