Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Xolair Adds Pollen Allergy Use in Japan after 19-Day Delay
Novartis’ asthma drug Xolair (omalizumab) received Japanese approval for an additional indication of pollen allergy on December 11, with the nod coming after a 19-day delay as the company asked regulators to push back their OK, saying it needed more…
To read the full story
Related Article
- Xolair’s Use Would Be Limited to 1-3% of Pollen Allergy Patients in Japan: Specialist
January 20, 2020
- Xolair’s Pollen Allergy Nod Delayed as Novartis Says It Needs More Time to Prepare for Launch
November 25, 2019
- Finance Officials, Payers Grow Jittery as Xolair’s Pollen Allergy Nod Looms
November 18, 2019
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
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…