PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
BUSINESS
Approval for Once-Monthly Aripiprazole Hits Snag in US: Otsuka
In a Complete Response Letter (CRL) from the US FDA, which Otsuka Pharmaceutical received on July 26 (US local time) for the extended release injection (once-monthly administration) for the antipsychotic Abilify (aripiprazole), it was pointed out that deficiencies were found…
To read the full story
BUSINESS
- Sumitomo’s Enzomenib Earns US Breakthrough Therapy Tag for Leukemia
October 28, 2026
- PDRadiopharma to Build 16.5 Billion Yen Plant in Chiba
October 28, 2026
- FRONTEO, Otsuka Tie Up on AI-Driven Kidney Drug Target Discovery
October 28, 2026
- Enhertu Reels in EU OK for Adjuvant Use in HER2 Breast Cancer
October 28, 2026
- Silchester Boosts Santen Stake Past 10%
October 28, 2026
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…