Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Xocova, Astellas’s Gastric Cancer Med Up for PAFSC Review on March 4; Pfizer’s Bispecific, RSV Jab Also on Agenda
A key Japanese health ministry panel will discuss regulatory approval for a throng of new medicines on March 4, including whether to grant full traditional clearance for Shionogi’s oral COVID-19 drug Xocova (ensitrelvir). Xocova is one of the eight new…
To read the full story
Related Article
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- AstraZeneca Seeks Label Expansion for Synagis in Japan
July 4, 2023
- Pfizer Japan Files BCMA Bispecific Elranatamab for MM
June 30, 2023
- Astellas Files Zolbetuximab for CLDN18.2-Positive Gastric Cancer in Japan
June 12, 2023
- Pfizer Japan Files RSV Vaccine for 60 Years of Age and Older
May 29, 2023
- Keytruda-Chemo Combo Filed for 1st Line Gastric Cancer in Japan: MSD
May 15, 2023
- Pfizer Japan Files 20-Valent Pneumococcal Vaccine for Pediatric Use
March 31, 2023
- Pfizer Files Tick-Borne Encephalitis Vaccine in Japan
March 29, 2023
- AstraZeneca Files Anti-RSV Antibody Nirsevimab in Japan
March 1, 2023
REGULATORY
- Wegovy’s MASH Label Expansion and More Up for Japan Panel Review on May 29
May 18, 2026
- Japan Eyes June Submission of Immunization Act Bill to Cover Antibody Drugs
May 18, 2026
- Calls Grow for Japan Version of EHDS at Regulatory Reform Panel
May 18, 2026
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…