What's Going On With Charles River, Certara, Simulations Plus Stocks On Friday?

The U.S. Food and Drug Administration announced a major shift in how monoclonal antibody therapies and other drugs are evaluated, emphasizing a transition from traditional animal testing.

The agency aims to adopt human-relevant and technologically advanced testing methods to improve safety evaluations, reduce research costs and accelerate drug development timelines.

The FDA’s new approach, outlined in a roadmap released on Thursday, encourages drug developers to integrate New Approach Methodologies (NAMs), including AI-driven simulations and laboratory-based human models.

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These alternatives are expected to provide more accurate predictions of human responses and toxicities, which can be difficult to detect through animal testing alone.

One key strategy promoted in the roadmap is the use of advanced computer modeling.

AI-based simulations can mimic how monoclonal antibodies travel through the human body and predict potential side effects based on the drug’s structure. The FDA believes this could significantly reduce the reliance on animals in preclinical studies.

In addition, the agency is supporting ...

https://www.benzinga.com/government/regulations/25/04/44764201/whats-going-on-with-charles-river-certara-simulations-plus-stocks-on-friday