Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

Full, planned acquisition of Tokyo-based operation will give US biotech giant a firmer foothold in key market and new platform for Otezla growth.

The Japanese environment for cell and gene therapies and regenerative medicine in general continues to be highly supportive. But will pricing pressures under the NHI scheme move to the fore as more expensive products come to market?

Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.

Corporate consolidation and specialization were major threads running through the 2010s in Japan. Reimbursement pricing issues continued to dominate the policy sphere while new forms of therapy benefited from positive regulatory reforms.