Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Takeda’s Eosinophilic Esophagitis Drug Rejected in US
Takeda Pharmaceutical said on December 22 that the US FDA has issued a complete response letter (CRL) rejecting approval of its eosinophilic esophagitis treatment TAK-721 (budesonide oral suspension).The drug maker said that the FDA concluded that an application for the…
To read the full story
Related Article
- Takeda Earns US Nod for Oral EoE Drug after Resubmission
February 14, 2024
- FDA Accepts Takeda’s Resubmission for Eosinophilic Esophagitis Drug
September 22, 2023
- Takeda’s Eosinophilic Esophagitis Med Gets Priority Review in US
December 17, 2020
BUSINESS
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
- Ipsen to Withdraw Tazverik Overseas over Secondary Cancer Risk
March 10, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…