The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
Three new medicines gained the blessing of a key health ministry panel on June 4 that sets the stage for their Japanese regulatory approvals, including MSD’s sotatercept and Pfizer’s etrasimod. Sotatercept was recommended approval by 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
- Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
June 25, 2025
- Pfizer’s UC Drug, MSD’s PAH Therapy, and More Up for Panel Review on June 4
May 22, 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
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
- Japan Moves LLP Payment Hike toward Political Call, Eyes 1/2 or Higher
December 18, 2025
- Panel to Weigh Orphan Designation for Tecartus on December 22
December 17, 2025
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
December 17, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…