Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 22, 2026
- Oncolys’ Telomelysin Wins Backing from Japan Panel
May 22, 2026
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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 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…