Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
No Add'l Safety Measures for Xocova Needed “at This Time”: MHLW Panel
Additional safety measures are “unnecessary” at the present time for Shionogi’s COVID-19 treatment Xocova (ensitrelvir), which was granted Japan’s first emergency approval, a health ministry panel agreed on December 27 based on its review of adverse event reports. The first…
To read the full story
Related Article
- Xocova Given to Over 50,000 Patients in 6 Months: Shionogi
June 6, 2023
- No Additional Safety Measures Needed at this Time for Xocova: Panel
May 11, 2023
- Over 40,000 Patients Given Xocova as of April 9: Shionogi
April 18, 2023
- Estimated 37,746 Patients Given Xocova as of March 19: Shionogi
March 29, 2023
- Additional Safety Measures for Xocova “Not Needed at This Time”: MHLW Panel
March 24, 2023
- Serious Side Effect Cases Total 8: Xocova Safety Update
March 13, 2023
- Xocova Taken by Estimated 32,270 Patients as of Feb. 19: Shionogi
February 28, 2023
- MHLW Panel Maintains Caution against Xocova Use in Women Who Might Be Pregnant
February 22, 2023
- Xocova’s Serious Side Effect Cases Total 5: Shionogi
February 13, 2023
- Japan to Revise Revlimid Risk Management Rule in June; February Generic Approval Eyed
January 25, 2023
- Estimated 11,867 Patients Given Xocova as of Jan. 5: Shionogi
January 16, 2023
- Shionogi Reports 2 Serious Side Effect Cases in Xocova Update
January 6, 2023
- Estimated 4,640 Patients Took Xocova by Dec. 18: Shionogi
December 27, 2022
- Estimated 1,024 Patients Took Xocova in First 11 Days: Shionogi
December 13, 2022
REGULATORY
- Japan Launches Biotechnology Working Group, Roadmap Draft Due in April
February 4, 2026
- Japan Panel Backs Nonprescription Switch of Second Emergency Contraceptive
February 4, 2026
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- Public Comments Warn Japan’s Drug Pricing System Cannot Reflect Inflation: Chuikyo
February 2, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…