Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Xolair’s Pollen Allergy Nod Delayed as Novartis Says It Needs More Time to Prepare for Launch
In a rare move, Japanese regulators have postponed approval for Xolair’s (omalizumab) additional pollen allergy indication - initially expected for late this month - at the request of its manufacturer Novartis, which says it needs more time to communicate information…
To read the full story
Related Article
- Xolair Adds Pollen Allergy Use in Japan after 19-Day Delay
December 12, 2019
- Finance Officials, Payers Grow Jittery as Xolair’s Pollen Allergy Nod Looms
November 18, 2019
REGULATORY
- LDP Pledges to Position Pharma as Core Industry in Campaign Platform
January 22, 2026
- Many Pharma-Savvy Lawmakers on LDP’s Candidate Roster for Lower House Poll
January 22, 2026
- Japan Health Minister Says Early Call on FY2027 Off-Year Revision Improves Predictability
January 22, 2026
- Japan Grants Sakigake Tag to Nanoscope’s MOGENRY
January 22, 2026
- MHLW Official Making Rounds to Rally Private Support for Drug Discovery Fund
January 21, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…