The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More
Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab). Arexvy became the…
To read the full story
Related Article
- Kyowa Kirin’s Phozevel Now Available for Hyperphosphatemia
February 20, 2024
- GSK’s Arexvy Hits Market as Japan’s 1st RSV Vaccine
January 15, 2024
- Phesgo, Epkinly, Leqvio Hit Japan Market, Wegovy Launch Set for Feb. 22
November 24, 2023
- 1st G-Lasta Biosimilar Gets Japan Listing, Stelara Follow-On Not on Roster
November 21, 2023
- Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds
November 16, 2023
- Japan Panel Clears GSK’s Arexvy, 1st RSV Vaccine, for Approval
August 29, 2023
- Japan Panel OKs Novartis’ siRNA Dyslipidemia Therapy and More
August 22, 2023
- Perjeta/Herceptin SC Combo, 1st Stelara, G-Lasta Biosimilars in Line for Japan Approval
August 1, 2023
REGULATORY
- 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
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
December 16, 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…