Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- US Narrows Scope of Medicare MFN Model, Exempts Orphan-Only Drugs
October 2, 2026
- Japan to Draw Up Growth Strategy Action Plan by Year-End
October 2, 2026
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…