Remove Animal Testing Remove Drug Development Remove Regulations
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FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. 7] This was a landmark change in philosophy.

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Altasciences and VoxCell Partner to Boost Preclinical Drug Development

The Pharma Data

This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.

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Time for change: non-human primates in drug research

Drug Target Review

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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Advanced 3D cell-based technologies

Drug Target Review

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.