Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Alexion’s Bleeding Antidote to Be Approved as Early as This Month
Japan’s health ministry plans to approve Alexion Pharmaceuticals’ andexanet alfa, an antidote for factor Xa inhibitors, now that it has cleared issues around its data integrity, an official said on March 23. The approval is expected as early as this…
To read the full story
Related Article
- Japan Approves Kerendia, Vabysmo, Ondexxya, Takhzyro and More
March 29, 2022
- Japan Approves Array of Fertility Treatments ahead of Coverage Rollout
March 16, 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
- Fertility Treatment Indications for 9 Meds to Be Reported to PAFSC Panel on March 9
February 25, 2022
- Data Integrity Risk Detected for Alexion’s Approval-Pending Bleeding Antidote, Report to Panel Put on Hold
September 24, 2021
- MHLW Panel Shelves Decision on Entresto’s Hypertension Use, Clears Otsuka’s Eczema Med and More
August 31, 2021
REGULATORY
- Govt to Explore Greater Rewards for Innovative Drugs in Honebuto
June 29, 2026
- MHLW Starts Technical Review of OTC-Like Drug Charge Exemptions
June 29, 2026
- MOF Panel Renews Push for Full-Scale Off-Year Revision in FY2027
June 29, 2026
- Government Unveils Four-Chapter Outline for 2026 Honebuto
June 26, 2026
- LDP, Ishin Leave Chuikyo Reform to Party Negotiators after Talks Stall
June 26, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…