Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Susmed Bags Japan Approval for Insomnia App
Tokyo-based health tech Susmed has won Japanese regulatory approval for its Med CBT-i, a cognitive behavioral therapy app for insomnia, it said on February 15. Given the green light on the same day as software as a medical device (SaMD),…
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’s Insomnia App in Line for Approval as Early as January
December 20, 2022
- 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
BUSINESS
- Otsuka/Ionis’ HAE Drug Dawnzera Approved in Europe
January 22, 2026
- Shionogi to Lift Stake in ViiV to 21.7% as Pfizer Exits
January 21, 2026
- Fuji Pharma Earns Approval for High-Dose Stelara Biosimilar
January 21, 2026
- Kaken’s Hyperhidrosis Drug Ecclock Now Available in South Korea
January 20, 2026
- Daridorexant Hits Primary Goal in South Korea PIII Insomnia Trial, Nxera Plans Filing in Q1 2026
January 20, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…