Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
Alexion’s Bleeding Antidote Up for PAFSC Discussion Again after Data Integrity Issues
A key health ministry panel will have another round of discussions on Alexion Pharmaceuticals’ andexanet alfa, an antidote for factor Xa inhibitors, on March 9, six months after its approval process was put on hold due to a possible data…
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
- 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
- Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme
November 6, 2026
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
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…