Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Pfizer’s Lorlatinib Gets 1st Conditional OK; MHLW Approves Astellas AML Drug and More
Pfizer’s lung cancer treatment Lorbrena (lorlatinib) earned the world’s first clearance in Japan on September 21, becoming the first drug to gain the nod under the country’s conditional early approval scheme introduced last October. Lorbrena was among a throng of…
To read the full story
Related Article
- Kyorin’s OAB Drug Vibegron and More Clear MHLW Panel; Official Nod Anticipated September
August 31, 2018
- Panel Gives Blessing for Pfizer’s Lorlatinib, Astellas AML Drug; Approval Expected in September
August 30, 2018
- MHLW Panel Backs Lilly’s Ibrance Contender Abemaciclib for Breast Cancer
August 6, 2018
- Daiichi Sankyo's Herceptin Biosimilar Now in Line for September Approval as It Clears MHLW Panel
August 6, 2018
- Boehringer’s DPP-4/SGLT2 Combo Clears MHLW Panel
July 30, 2018
REGULATORY
- MHLW Revises Biological Raw Material Rules, Clarifies Donor Testing Flexibility
April 2, 2026
- Japan Officially Eases Trial Recruitment Rules; Industry Welcomes Move
April 1, 2026
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- Japan Panel Designates Two Ebola Therapies for Early Approval Pathway
April 1, 2026
- MHLW, METI Launch Joint Task Force to Safeguard Medical Supply Chains
April 1, 2026
Japan will overhaul its R&D tax credit regime in its FY2026 reform, introducing a new strategic category alongside existing frameworks.…
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
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…