1. Pink Sheet
  2. >>Advanced Technologies
  3. >>AI

Boosting Reliability: EMA Backs AI Tool For MASH Trials

 
• By Neena Brizmohun

An artificial intelligence-based pathology tool for metabolic dysfunction-associated steatohepatitis shows promise for a drug development landscape that is said to be “fraught with trials that have shown borderline results or outright failures based on liver histology.”

Medicine woman doctor touching digital medical record tablet with Liver. AR of healthcare and network
An AI tool could help with histologic endpoint assessment in MASH trials (Shutterstock)
Key Takeaways
  • The European Medicines Agency has issued a draft qualification opinion recommending the use of an AI-based pathology tool in clinical trials of drugs for metabolic dysfunction-associated steatohepatitis (MASH).

The European Medicines Agency is seeking feedback on the use of an artificial intelligence (AI)-based pathology tool that could provide...

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 AI

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

More from Pink Sheet

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.