Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Novartis’ Radioligand Therapy, Other New Meds Up for Japan Panel Review on Aug. 22
A Japanese health ministry panel will meet on August 22 to consider approval of Novartis’ radioligand therapy lutetium vipivotide tetraxetan (177Lu) for certain prostate cancer patients and Servier’s glioma treatment vorasidenib, along with other new drugs and label expansions. The…
To read the full story
Related Article
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
- Nippon Kayaku Files Nuvation-Partnered ROS1 Inhibitor in Japan
March 5, 2025
- Boehringer Files Zongertinib in Japan for HER2 Lung Cancer
February 19, 2025
- Nihon Servier Files Glioma Drug Vorasidenib in Japan
December 25, 2024
- Alfresa Files ARS’ Epinephrine Nasal Spray in Japan
December 2, 2024
- Vectibix Plus Lumakras Filed for Colorectal Cancer in Japan
November 11, 2024
- Tecentriq Filed for Rare Nasal Lymphoma in Japan: Chugai
November 1, 2024
REGULATORY
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Executives Urge Stronger CDMO, CRO Base at Drug Discovery WG Meeting
February 27, 2026
- Japan to Closely Monitor US “MFN” Policy: PM Takaichi
February 27, 2026
- Japan to Update Adult Pneumococcal Fact Sheet Ahead of Capvaxive NIP Review
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…