Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
BMS Unit Wins Japan Approval for Sprycel Authorized Generic
Bristol Myers Squibb said on August 16 that its fully owned subsidiary has earned Japanese regulatory approval for an authorized generic (AG) version of its tyrosine kinase inhibitor Sprycel (dasatinib). The AG will be pitted against copycat versions already on…
To read the full story
Related Article
- Sawai Wins Lawsuit over CML Use in Sprycel Generic
May 19, 2025
- Preliminary Injunction for Sprycel Generic “Extremely Unjust”: Sawai
December 5, 2023
- Sawai Slapped with Preliminary Injunction for Sprycel Generic over CML Use
November 30, 2023
- BMS Seeks to Block Sawai’s Sprycel Generic over CML Use
November 7, 2023
- Sawai Bags CML Nod for Sprycel Generic
October 5, 2023
- Japan OKs 1st DPP-4 Generic for Januvia, Zytiga Draws 6 Entrants towards December Listing
August 16, 2023
BUSINESS
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Japan Grants First-Ever Approval to iPSC-Based Therapies
March 6, 2026
- Meiji Starts Japan PIII Trial of Rezurock for CLAD
March 6, 2026
- Meiji Rolls Out Rezurock in Taiwan
March 6, 2026
- Toray Out-Licenses Parkinson’s Drug to Immunis
March 6, 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…