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
- 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
- Takeda to Shift Immunoglobulin Production to 10% Formulation
June 29, 2026
- Japan’s Immunoglobulin Self-Sufficiency Rate Falls Below 60%
June 29, 2026
- MOF Panel Renews Push for Full-Scale Off-Year Revision in FY2027
June 29, 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…