Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Gene Therapy Luxturna Now in Line for Approval in June
Novartis’ gene therapy for inherited retinal disease LTW888, known as Luxturna overseas, sailed through a review by a key health ministry advisory committee on May 26, with the panel’s nod setting the stage for its approval as early as June.…
To read the full story
Related Article
- Novartis Rolls Out Luxturna in Japan, 2 Treatment Facilities Selected
August 31, 2023
- Luxturna Priced at 49.6 Million Yen per Vial, Peak Sales Put at 500 Million Yen with 5 Patients
August 24, 2023
- Drug Pricing Rules to Be Applied to Novartis’ Gene Therapy Luxturna
July 6, 2023
- Japan Approves Novartis’ Gene Therapy Luxturna for Rare Eye Disease
June 27, 2023
REGULATORY
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- Wholesalers Urge Price Hikes on Sub-20-Yen Drugs as Negative Margins Mount
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence 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…