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 Label Expansions for Alecensa, Nucala and More
The Japanese health ministry on August 28 approved a batch of medicines for additional indications or dosages, including Chugai Pharmaceutical’s cancer treatment Alecensa (alectinib) and GlaxoSmithKline’s anti-IL-5 antibody Nucala (mepolizumab). Alecensa was awarded approval for its use as a postoperative…
To read the full story
Related Article
- 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
- Gilead Files Truvada for HIV Prevention in Japan
February 29, 2024
- Truvada Clears Preliminary Review for PrEP Use, but Coverage Not Granted
February 6, 2024
- Alecensa Filed for Adjuvant Therapy for ALK-Positive NSCLC: Chugai
December 18, 2023
- Pfizer Japan Files 20-Valent Pneumococcal Jab for Older Adults, High-Risk People
September 14, 2023
- Keytuda Filed in Japan in NSCLC Neoadjuvant/Adjuvant Setting: MSD
September 8, 2023
- Nucala Filed in Japan for Chronic Rhinosinusitis with Nasal Polyps: GSK
September 5, 2023
REGULATORY
- LDP Pharma Project Team to Compile Roadmap Proposals after Industry Hearings
April 17, 2026
- DPJ Leader to Urge Drug Price Hikes, “Freeze” on Off-Year Revisions
April 17, 2026
- War-Linked Supply Impact Cases Climb to 34 as Japan Steps Up Response
April 17, 2026
- Meiji Pharma Chair Prods Drug Price Hikes as War Drives Up Costs: Diet
April 17, 2026
- Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias
April 17, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…