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
- Japan Begins Review of Domestic CGT Seeds with Limited Market Potential
June 30, 2026
- Govt Panel Urges 2027 Bill to Expand Secondary Use of Health Data
June 30, 2026
- Japan Panel OKs Carvykti’s Earlier Use in Multiple Myeloma
June 30, 2026
- Govt to Explore Greater Rewards for Innovative Drugs in Honebuto
June 29, 2026
- MHLW Starts Technical Review of OTC-Like Drug Charge Exemptions
June 29, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…