Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Sakigake-Designated HAE Med Berotralstat, AZ’s Acalabrutinib Clear PAFSC Review
OrphanPacific’s sakigake-designated hereditary angioedema (HAE) treatment berotralstat, which was developed by BioCryst Pharmaceuticals, cleared a key health ministry panel on October 30, along with AstraZeneca’s chronic lymphocytic leukemia (CLL) drug acalabrutinib. Berotralstat, an oral plasma kallikrein inhibitor otherwise known as…
To read the full story
Related Article
REGULATORY
- Pharma Continues Reform Push at 2nd Public-Private Subgroup Meeting
October 13, 2026
- AbbVie’s TrenibotE Up for Review on Oct. 26, Aquipta on Agenda Too
October 13, 2026
- Japan Panel to Review Full Approval of Nipro’s Stemirac on October 15
October 13, 2026
- Japan Finalizes Medical Data Sharing Blueprint, Eyes 2027 Bill
October 13, 2026
- AlliedCel Takes Over Sakigake Designation for Junten Bio’s T-Cell Therapy
October 13, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…