Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Pfizer’s UC Drug, MSD’s PAH Therapy, and More Up for Panel Review on June 4
A key health ministry advisory panel will discuss on June 4 a long list of new medicines and label extensions for their regulatory approval in Japan, among them being Pfizer’s ulcerative colitis (UC) treatment etrasimod. The Pharmaceutical Affairs Council’s First…
To read the full story
Related Article
- Mochida’s Low-Dose Lialda to Hit Shelves in September
August 19, 2025
- MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
June 5, 2025
- MSD Files PAH Treatment Sotatercept in Japan
November 15, 2024
- Amvuttra Filed for ATTR-CM in Japan: Alnylam
November 12, 2024
- Aculys Pharma Files Diazepam Nasal Spray in Japan
September 3, 2024
- Tremfya Filed for Crohn’s Disease in Japan: J&J
August 13, 2024
- Takeda Seeks CIDP Nod for Immunoglobulin Hyqvia in Japan
August 9, 2024
- Mochida Files Pediatric Dosage of UC Drug Lialda in Japan
July 23, 2024
- Pfizer Seeks Japan Approval for Ulcerative Colitis Drug
July 1, 2024
- Mundipharma Files Anesthetic Med Anerem for New Indication in Japan
September 28, 2023
REGULATORY
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
- MHLW Panel Backs Easing Protopic Contraindication for Young Children
September 30, 2026
- PMDA Flags New Safety Risks with 3 Drugs
September 30, 2026
- CEA Transparency Gains Welcome, but Guidelines Need Scrutiny: Economist
September 30, 2026
- More Company Involvement in CEA a Big Positive: C2H Researcher
September 29, 2026
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…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…