Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
Eli Lilly’s Alzheimer’s therapy Kisunla (donanemab) landed Japanese regulatory approval on September 24 along with scores of other medicines, making it the second anti-amyloid β (Aβ) antibody to fight the memory-robbing disease in Japan, after Leqembi (lecanemab). Kisunla was approved…
To read the full story
Related Article
- Kisunla Uptake “as Expected” One Year after Approval, Says Lilly Japan Exec
September 19, 2025
- Tepezza, Trodelvy, and More Drugs Now Available in Japan; Kisunla Due Out on Nov. 26
November 21, 2024
- Japan to Apply Leqembi’s General Pricing Rules for Similar AD Therapies
November 14, 2024
- Kisunla to Follow Same Rules as Leqembi in Pricing and Post-Launch Review
October 10, 2024
- Kisunla Subject to Prior Pricing Review as It Follows Leqembi’s Footsteps
September 26, 2024
- J&J to Offer Rybrevant for Free until NHI Price Listing
September 26, 2024
- Trodelvy Nears Japan Approval as It Sails through Panel Review
September 13, 2024
- Japan Panel OKs BMS ROS1 Inhibitor, Janssen Bispecific, JN.1-Targeted Nuvaxovid
September 2, 2024
- Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
August 28, 2024
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- Takeda’s Fruzaqla in Line for Approval, Broader Labels for Truvada, Keytruda, Prevenar 20 Too
August 5, 2024
- Lilly’s Alzheimer’s Med Donanemab Now in Line for Japan Approval
August 2, 2024
REGULATORY
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- PMDA Flags Iron Products, ST Combination Drug in Risk Review
May 20, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan Approves Jascayd, mNEXSPIKE, Zepbound OSA Use, Others
May 19, 2026
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 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…