1. Pink Sheet

EMA Will Observe Project Orbis In Effort To Increase Collaboration

 
• By Derrick Gingery

The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.

US and EU gears
The details of the EMA's Project Orbis observer status have not been finalized. • Source: Shutterstock

The European Medicines Agency is not ready to join Project Orbis, the US FDA’s framework for concurrent international review of oncology applications, but will be watching the process more closely as an observer going forward.

The move seems almost anti-climactic given that the EMA and the FDA already work together closely on cancer products. EMA...

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 Product Reviews

More from Pink Sheet

Inside Elamipretide’s CRL: Clinical And Surrogate Evidence Deficiencies, And A Path Forward

 
• By Sue Sutter

The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.

Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By Cathy Kelly

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.