Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Data Integrity Risk Detected for Alexion’s Approval-Pending Bleeding Antidote, Report to Panel Put on Hold
Alexion Pharmaceuticals’ andexanet alfa, an antidote for factor Xa inhibitors, was expected to be approved by the end of September, but a data integrity risk that has been detected is now casting clouds on this timeline. Andexanet alfa, known as…
To read the full story
Related Article
- Alexion’s Bleeding Antidote to Be Approved as Early as This Month
March 24, 2022
- Panel Confirms Backing for Alexion’s Bleeding Antidote after Data Integrity Issues
March 10, 2022
- Alexion’s Bleeding Antidote Up for PAFSC Discussion Again after Data Integrity Issues
March 3, 2022
- MHLW Panel Shelves Decision on Entresto’s Hypertension Use, Clears Otsuka’s Eczema Med and More
August 31, 2021
REGULATORY
- US Calls Out Japan’s Market Expansion Re-Pricing Rules as “Unfair”: IP Report
May 26, 2026
- CEA Review Group Holds First Meeting, Technical Debate Yet to Begin
May 26, 2026
- AstraZeneca’s Oral SERD, MSD RSV Antibody Clear Japan Panel Review
May 26, 2026
- Japan Mulls Target on “Social Security Burden Rate” after CEFP Call
May 25, 2026
- Ishin Deepens Debate on Healthcare Macroeconomic Indexing
May 25, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…