Japan has issued positive approval recommendations for 10 new drugs, including Catalyst’s Firdapse and Idorsia/Nxera’s Quviviq, as well as a global-first nod for mecobalamin in ALS. 

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

While its European licensee is preparing for an imminent launch, Kissei has also been expanding its partnerships in Asia for female health product linzagolix. A new alliance is also being sought in the US to assist with a new trial and NDA refiling there.

Plus deals involving Healios/Astellas Institute for Regenerative Medicine, Otsuka/Ionis, IMBiologics/Navigator and more.