Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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
- Regeneron Lines Up 5 Late-Stage Assets for Japan: Commercial Head
December 11, 2025
- Asahi Kasei Pharma Confident of Hitting FY2030 Group Sales Target: President
December 10, 2025
- Astellas Sees Xtandi Patent Cliff a “Critical Phase,” Steps Up Board Oversight via EPM
December 10, 2025
- PeptiDream Hits Milestone with Asahi Kasei Collaboration
December 10, 2025
- Eisai’s Leqembi Added to China Commercial Insurance Drug List
December 10, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…