Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan OKs Enhertu, 3 Sakigake Drugs, Beovu, Latuda, and More
The Ministry of Health, Labor and Welfare (MHLW) on March 25 gave the green light to a slew of new medicines, including Daiichi Sankyo’s cancer drug Enhertu (trastuzumab deruxtecan) and Novartis’ Eylea (aflibercept) rival Beovu (brolucizumab). The MHLW granted conditional…
To read the full story
Related Article
- Daiichi Sankyo’s Enhertu Hits Japan Market for Breast Cancer
May 26, 2020
- Daiichi Sankyo’s Enhertu, Novartis’ Beovu, Novo’s Ozempic OK’ed for Listing on May 20
May 13, 2020
- MHLW Panel Clears Latuda, 1st Japan-Originated Oligonucleotide; Approval Expected in March
March 2, 2020
- Daiichi Sankyo’s Enhertu Clears MHLW Panel, Conditional Nod Expected in March
February 27, 2020
- MHLW Panel Backs Approval of Sakigake-Designated BNCT Radiation Therapy System
February 20, 2020
- Takeda’s RCC Drug Cabometyx Now in Line for March Approval; Alecensa, Rozlytrek Opdivo and More
January 30, 2020
- MHLW Panel Gives Thumbs Up for Novartis’ ADM Med Brolucizumab for Approval in as Early as March
January 29, 2020
REGULATORY
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
- MHLW Clarifies Up to 12-Year Data Protection for Pediatric Development
March 2, 2026
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…