1. Pink Sheet
  2. >>R&D

EMA To Address Challenges Of Using Organ-On-Chip Models In Drug Development

 
• By Neena Brizmohun

Microphysiological systems such as organ-on-chip models could not only improve the translational success of drug candidates into the clinic, but also impact the 3Rs in non-clinical safety testing, according to the European Medicines Agency.

liver AI image
Microphysiological systems have evolved significantly • Source: Shutterstock

The European Medicines Agency is looking to foster the uptake of organ-on-chip (OoC) models and other microphysiological systems (MPS) in drug development and regulatory submissions, according to its planned revision of its seven-year-old guideline on the replacement, reduction and refinement (3Rs) of animal studies.

MPS models could be more predictive of in vivo biology than the in vitro and in vivo models currently used,...

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 R&D

Speed, Reach And Impact: New Metrics To Drive EU Clinical Trials Reform

 
• By Vibha Sharma

Clinical trials in the EU will be measured against new benchmarks from 2026 to identify how the bloc’s clinical research environment compares with that of other regions, and to identify areas for improvement.

HHS Long COVID Initiative Will Focus On ‘Front Line’ Approach To Treatment

 
• By Cathy Kelly

A project to advance effective treatments for long COVID was framed as a high priority for HHS Secretary Robert F. Kennedy Jr.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By Vibha Ravi

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

More from Pink Sheet

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 
• By Francesca Bruce

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 
• By Sarah Karlin-Smith

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.