News & Analysis

Curated news and analysis on clinical trials, drug approvals, and medical research.

Kintsugi Shuts Down, Open-Sources Voice Biomarker AI for Depression and Anxiety Detection

Kintsugi, a startup developing AI to detect depression and anxiety from voice, is shutting down and open-sourcing its technology due to costly FDA regulatory hurdles. The company’s models analyzed brief speech samples and showed significantly higher depression detection rates than standard questionnaires in a health payer trial. The release aims to empower global research into voice biomarkers for mental healthcare.

India Adds Stronger Safety Warnings to Doxycycline and Carbimazole Packages

India's drug regulator has mandated stronger safety warnings for doxycycline and carbimazole after a national review of adverse reaction reports. Doxycycline packages will now list potential mental health side effects such as anxiety and dizziness, while carbimazole will warn of a rare blood disorder.

Sandoz Wins EC Approval for Two Insulin Biosimilars

The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.

Experimental ETVAX E. coli Vaccine Shows Promise in Phase 2 Trial

The investigational ETVAX oral vaccine showed safety and immune responses in a Gambia-based phase 2b trial for enterotoxigenic E. coli. Efficacy reached 80.6% when excluding enteroparasitic pathogens. Results support progression to a phase 3 trial in high-burden settings.

Newer
Sorted by date
Older
Showing 20 articles per page