Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Turns Down Label Update for Izervay, Astellas Eyes Re-Filing
Astellas Pharma said on November 19 that the US FDA has declined to approve a label update that the company sought for its complement C5 inhibitor Izervay (avacincaptad pegol) to include favorable two-year clinical trial data. The drug scored the…
To read the full story
Related Article
- FDA Approves Izervay’s Wider Label with No Dosing Duration Limit
February 14, 2025
- FDA Accepts Re-Submission of Izervay to Buttress Label
January 10, 2025
- Astellas Pulls EU Filing for Geographic Atrophy Drug
October 29, 2024
- Izervay Slows Geographic Atrophy Lesion Growth through 2 Years: Astellas
November 7, 2023
- Iveric Bio’s AMD Drug Approved in US, Launch Set for This Month: Astellas
August 8, 2023
BUSINESS
- Japan Pharma Workforce Up Slightly; Generic Firms Drive Gains over 5 Years
April 10, 2026
- Zenyaku, Chugai to End Rituxan Co-Promotion in September
April 10, 2026
- Effexor’s GAD Nod Seen Boosting Diagnosis, Treatment in Japan: Expert
April 10, 2026
- MSD Japan Eyes Up to 8 Approvals, 8-Plus Filings under New Chief
April 10, 2026
- Pfizer Japan Files Tukysa Label Expansion in Breast, Biliary Tract Cancers
April 9, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…