Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
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 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
- UCB Japan Launches IV Form of Epilepsy Med Briviact
April 18, 2025
- Investments Follow Where Innovation Is Valued, Says Novartis Japan Chief
April 18, 2025
- Gilead Shelves Sunlenca’s PrEP Program in Japan as Coverage Issue Weighs
April 17, 2025
- Gilead Japan Revving Up Oncology Drive with Trodelvy, CAR-T as Legs of Growth
April 17, 2025
- Amgen Rolls Out Imdelltra for SCLC in Japan
April 17, 2025
Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…