Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
Sawai Fudged Quality Tests of Gastritis Drug for 8 Years, Awaiting Penalty Decision
Sawai Pharmaceutical said on October 23 that it had improperly carried out quality testing for its gastritis and gastric ulcer drug Teprenone Capsules for as long as eight years since 2015. Regulatory authorities believe that this constitutes a violation of…
To read the full story
Related Article
- Sawai and Kaigen Submit Biz Improvement Plans to Osaka Govt
February 14, 2024
- JGA Issues Written Reprimand to Sawai over GMP Issues
January 30, 2024
- (Update) Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
December 25, 2023
- Sawai Slapped with Biz Improvement Order over Rigged Quality Tests
December 22, 2023
- LDP Lawmakers Deplore Reported GMP Issues at Sawai
September 8, 2023
BUSINESS
- Japan’s 1st Xolair Biosimilar Finally Set for December Launch after Delays
October 23, 2026
- PHP Security Flaws Trigger Website Shutdowns Across Japan Pharma Sector
October 23, 2026
- Enhertu Snares China Approval for HER2 Positive Solid Tumors
October 23, 2026
- Nxera Seeks South Korean Approval for DMD Drug Vamorolone
October 23, 2026
- Vital KSK Warns of Possible Email Address Leak via External Mail Provider
October 23, 2026
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…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…