Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
REGULATORY
MHLW Approves Vyvanse, Biktarvy, Trelegy, Vyndaqel, Dupixent Asthma Use and More
The Ministry of Health, Labor and Welfare (MHLW) on March 26 approved a long list of new medicines including Shionogi’s pediatric ADHD drug Vyvanse (lisdexamfetamine dimesylate) and Gilead Sciences’ HIV triplet Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide fumarate (TAF)).…
To read the full story
Related Article
- Japan Sets 30 Day Prescription Limit for Shionogi’s ADHD Med Vyvanse
May 29, 2020
- MHLW Panel Clears Biktarvy, Trelegy, Dupixent Asthma Use; Actemra OK’ed for CAR-T Side Effect
February 25, 2019
- MHLW Panel OKs Pfizer’s Vyndaqel for Sakigake-Designated Use
February 22, 2019
- Vyvanse Clears MHLW Panel after a Hold; Approval Expected in March
February 22, 2019
REGULATORY
- PMDA Halts Medical Device Application Platform after Unauthorized Access
October 30, 2026
- Drug Makers Can Refuse Diabetes Drug Supply over Improper Prescribing: JFTC
October 30, 2026
- Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
October 29, 2026
- FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
October 29, 2026
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…