Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
BUSINESS
FGF23 Antibody Burosumab Earns FDA Priority Status: Kyowa Kirin/Ultragenyx
Kyowa Hakko Kirin and its US partner Ultragenyx Pharmaceutical said on October 10 that the US FDA has accepted a biologics license application for their anti-FGF23 monoclonal IgG1 antibody burosumab, and granted a priority review status for the drug.The application…
To read the full story
Related Article
- XLH Drug Crysvita Now Available in US: Kyowa Kirin/Ultragenyx
May 8, 2018
- FDA Clears Kyowa Kirin/Ultragenyx’s XLH Drug Burosumab
April 19, 2018
- FGF23 Antibody Burosumab Filed in US: Kyowa Kirin, Ultragenyx
August 28, 2017
- August FDA Filing Planned for FGF23 Antibody Burosumab: Kyowa Kirin
July 31, 2017
BUSINESS
- Takeda Returns to Core Profit Growth, CEO Confident in Trajectory
October 30, 2026
- Novartis Japan President Pullicino to Step Down for Global Role
October 30, 2026
- Lilly’s Imulrio Reaches Japan Market 10 Months after Approval
October 30, 2026
- Ono’s First-Half Operating Profit Up 11% Despite Forxiga Sales Hit
October 30, 2026
- Shionogi Logs Record H1 Revenue as Acquisitions Pay Off
October 30, 2026
The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…