1. Pink Sheet

Diabetes Drug Safety Might Be Best Assessed With Real-World Data

 
• By Sue Sutter

Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.

A meta-analysis suggesting comparable efficacy and cardiovascular safety across multiple classes of diabetes drugs may renew questions about FDA's requirement for large CV outcomes studies for new treatments.

The findings point to the need for new thinking about how drugs for type 2 diabetes are studied, including the potential use of real-world evidence and alternatives to

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Drug Safety

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.