Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Susmed’s Insomnia App in Line for Approval as Early as January
A Japanese health ministry advisory panel on December 19 recommended approval for a digital therapeutic app for insomnia developed by Tokyo-based health tech Susmed, opening the way for its green light as early as next month. The Pharmaceutical Affairs and…
To read the full story
Related Article
- Susmed Wins Partial Change Approval for Insomnia App, Seeks Coverage
September 8, 2025
- MHLW Panel to Further Review Positioning of Susmed’s Insomnia App
July 31, 2025
- Susmed Seeks Partial Change of Approval for Insomnia App towards Coverage
September 3, 2024
- Susmed Drops Reimbursement Request for Insomnia App
January 30, 2024
- Susmed Bags Japan Approval for Insomnia App
February 20, 2023
- Susmed’s Insomnia App Up for PAFSC Review on December 19
December 6, 2022
- Shionogi Gets Commercial Rights to Susmed’s Insomnia App
December 28, 2021
REGULATORY
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
- Aspirin, CAR-T and Other Products under PMDA Safety Review
December 8, 2025
- R&D Tax Credit Draws Broad Calls for Maintenance, Expansion: LDP Meeting
December 8, 2025
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
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…
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
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…