Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Toho Builds Alternative Drug Delivery Options for Disaster Readiness
August 25, 2026
- OB/GYN Sees Abrysvo Becoming Part of Prenatal Care as NIP Drives Uptake
August 25, 2026
- Daiichi Sankyo Taps Ken Keller as New Commercial Chief in Global Revamp
August 25, 2026
- MSD Launches RSV Antibody Enflonsia in Japan without NHI Listing
August 24, 2026
- Sumitomo Pharma Eyes Global Position as Adjuvant Supplier
August 24, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…