Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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 Picks 5 COVID Vaccines for NIP Use from October
September 3, 2026
- New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
September 3, 2026
- MHLW Insurance Chief Vows Thorough Outreach on OTC-Like Drug Charges
September 3, 2026
- MHLW Scraps Routine Reporting for Type 1 Use under Cartagena Act
September 3, 2026
- Japan to Ease Lifetime Blood Donation Ban for Transfusion Recipients
September 3, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…