Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Pfizer’s Comirnaty Clears Key Panel for Ages 5-11; Actemra Set for COVID-19 Nod
A pediatric version of Pfizer’s COVID-19 vaccine Comirnaty passed the review of a key health ministry panel for use in children aged five through 11 on January 20, putting it in line for special approval as early as January 21.…
To read the full story
Related Article
- Japan Panel OKs Free COVID-19 Vaccination for Ages 5-11, but No “Effort” Obligation Applied
February 14, 2022
- Japan to Import Pfizer’s Pediatric Vaccine Next Month, Inoculations to Begin in March: Minister
January 25, 2022
- Pfizer’s Comirnaty Bags Japan Approval for Ages 5-11; Actemra OK’ed for COVID-19
January 21, 2022
- Pfizer’s Comirnaty Up for PAFSC Review for Ages 5-11 on Jan. 20; Actemra to Add COVID-19 Use
January 14, 2022
- Chugai Files Actemra for COVID-19 Pneumonia in Japan
December 14, 2021
- Pfizer’s COVID-19 Vaccine Filed for Children 5 to 11 in Japan
November 10, 2021
REGULATORY
- Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
- Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
- Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
- PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…