Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
European Regulators Accept Aducanumab for Review: Biogen/Eisai
Biogen and partner Eisai said on October 30 that a marketing authorization application for their investigational Alzheimer’s disease drug aducanumab has been accepted for review by the European Medicines Agency (EMA). The drug will now be reviewed by the regulator…
To read the full story
Related Article
- Biogen to Challenge European Rejection of Aducanumab
December 20, 2021
- Aducanumab Gets “Negative Trend Vote” in Europe: Biogen/Eisai
November 18, 2021
- Aducanumab Submitted in Japan, but Decision Unlikely to Come Until Next Autumn
December 11, 2020
- Biogen Files Japan NDA for Aducanumab
December 10, 2020
- Aducanumab Filed in Europe: Biogen/Eisai
October 22, 2020
BUSINESS
- Takeda Turns the Page to Kim’s “10-Year” Era, Betting on New Drugs and AI
June 26, 2026
- Sangamo Files Chapter 11, Astellas and Lilly Eye Key Assets
June 26, 2026
- Otsuka’s Centanafadine Meets PIII Goal in ADHD Patients with Anxiety
June 26, 2026
- Shionogi Welcomes Government Roadmap’s Focus on Infectious Diseases
June 26, 2026
- Sawai Cleared to Manufacture Nichi-Iko’s Lipitor Generic
June 26, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…