Japan’s recent Upper House election delivered a stinging defeat for the ruling Liberal Democratic Party (LDP) and junior coalition partner…
BUSINESS
Takeda Seeks CIDP Nod for Immunoglobulin Hyqvia in Japan
Takeda Pharmaceutical said on August 8 that it has filed TAK-771, a combination of human immunoglobulin infusion and recombinant human hyaluronidase, known as Hyqvia overseas, for the indication of chronic inflammatory demyelinating polyneuropathy (CIDP) in Japan. In Japan, the product…
To read the full story
Related Article
- MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
June 5, 2025
- Pfizer’s UC Drug, MSD’s PAH Therapy, and More Up for Panel Review on June 4
May 22, 2025
- Takeda Files Immunoglobulin Hyqvia in Japan
February 15, 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
- ASKA, Kyorin End Partnership on BPH Drug AKP-009
August 5, 2025
- Hisamitsu Launches Japan PIII of Microneedle-Based Topical Drug
August 5, 2025
- Kyowa Kirin CEO Highlights Resource Shift toward Innovative Drugs in Japan
August 4, 2025
- Rohto Pairs with Taiwan’s Formosa to Fuel Regenerative Medicine Business
August 4, 2025
- Leqembi Maintains Benefits in Early Alzheimer’s after 4 Years of Treatment
August 1, 2025
A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…