Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Takeda Files Immunoglobulin Hyqvia in Japan
Takeda Pharmaceutical said on February 14 that it has submitted a new drug application for a combination of human immunoglobulin infusion and recombinant human hyaluronidase, known as Hyqvia overseas, for the treatment of agammaglobulinemia and hypogammaglobulinemia. Agammaglobulinemia and hypogammaglobulinemia are…
To read the full story
Related Article
- Daiichi Sankyo’s TROP2 ADC, AZ’s COVID Antibody, Mpox Med in Line for Japan Approval
December 9, 2024
- AstraZeneca’s COVID Antibody, Daiichi’s TROP2 ADC, and More Up for Review on Dec. 6
November 25, 2024
- Takeda Seeks CIDP Nod for Immunoglobulin Hyqvia in Japan
August 9, 2024
- Takeda’s Hyqvia Nabs European Approval for CIDP Maintenance Therapy
January 31, 2024
- Takeda’s Hyqvia Earns US Nod for CIDP Maintenance Therapy
January 18, 2024
- Takeda’s Hyqvia Gets EU Panel Backing for CIDP Maintenance Therapy
December 19, 2023
- Takeda’s Hyqvia Smashes Primary Goal in Global PIII for CIDP
July 25, 2022
BUSINESS
- Fuji Plans July Launch for Japan’s 1st Simponi, Ranmark Biosimilars
May 21, 2026
- Myelofibrosis Med Inrebic to Go on Sale June 1: Recordati Japan
May 21, 2026
- Fujifilm Opens New US Facility, Expands iPSC-Derived Cell Production
May 21, 2026
- BMS, Nikon Pitch Japan-to-Asia Cell Therapy Push, Draw Support at Policy Forum
May 21, 2026
- High-Dose Uptravi Now Available: Nippon Shinyaku
May 21, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…