Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Panel to Review MSD’s 21-Valent Pneumococcal Shot, Silgard 9 for Male Use and More Label Expansions
A key health ministry advisory panel on July 24 will discuss whether to recommend approval for a batch of label expansions as well as one new vaccine developed by MSD - a 21-valent pneumococcal conjugate vaccine, known as Capvaxive overseas.…
To read the full story
Related Article
- MSD’s 21-Valent Pneumococcal Shot Nears Japan Approval; Male Use of Silgard 9 Cleared
July 25, 2025
- MSD Files Silgard 9 for Male Use in Japan
November 18, 2024
- Enhertu Filed for HER2 Low or Ultralow Breast Cancer in Japan
October 7, 2024
- Opdivo-Yervoy Filed for 1st Line Use in MSI-H Colorectal Cancer in Japan
September 13, 2024
- MSD Seeks Japan Nod for 21-Valent Pneumococcal Jab for Adults
August 13, 2024
REGULATORY
- LDP Project Team Flags Drug Pricing as Key to Investment
March 19, 2026
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
- MHLW Seeks Industry Survey on Petroleum-Linked Products amid Iran Crisis
March 18, 2026
- MHLW Orders Label Revisions for Antiepileptics and Other Drugs
March 18, 2026
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…