Digital Measures in Clinical Trials: FDA vs EMA Pathways
Explore how novel digital measures gain regulatory acceptance in clinical trials, comparing FDA-structured pathways with EMA engagement-led frameworks.
Libre Duo FDA Authorisation Through De Novo Pathway
Abbott’s Libre Duo FDA authorisation creates a new Class II device category, combining glucose and ketone monitoring while setting a regulatory path for future devices.
CMS Finalises Medicare GLOBE to Rewrite Drug Pricing
The Medicare GLOBE drug payment uses international drug prices to reshape selected Medicare Part B rebates. Here is what the final CMS rule means for pharma.
Where Healthcare AI Investment Is Going — And Where It Isn't
The data is out: Two-thirds of AI healthcare startup investment went to just three domains. Insight into clinical leadership, gender inclusivity, and geographical access reveals a sector building for investability… not clinical need.
The AI Bioweapons Risk: We Cannot Afford to Look Away
The risk of AI being used to create a bioweapon is a serious concern for pharma biosecurity after researchers found AI-designed toxins can evade DNA screening. Here’s what you need to know about the AI and bioweapons risk.
AI in Pharma: Hype vs. What Actually Works
Expert Lara Masad explains why pharma leaders miscalculate AI investments and how to build a defensible validation strategy.