Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Aducanumab Gets “Negative Trend Vote” in Europe: Biogen/Eisai
Biogen has received a “negative trend vote” from a key European regulatory panel on its controversial Alzheimer’s treatment aducanumab, signaling that the drug could face a rejection in the region after the US FDA’s polarizing decision to grant it accelerated…
To read the full story
Related Article
- Biogen to Challenge European Rejection of Aducanumab
December 20, 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
- European Regulators Accept Aducanumab for Review: Biogen/Eisai
November 2, 2020
- Aducanumab Filed in Europe: Biogen/Eisai
October 22, 2020
BUSINESS
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
- Takeda Swings to Loss after Booking Amitiza Litigation Charge
June 8, 2026
- GNI to Acquire Ayumi Pharma in 44.8 Billion Yen Deal
June 8, 2026
- Shionogi Releases Japan’s First Therapy App for Pediatric ADHD
June 8, 2026
- Kaken Files Head Lice Treatment in Japan
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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 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…