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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. Research using NHPs often requires detailed justification, approval by ethics committees and regular inspections.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

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AI Unleashed: Transforming Drug Discovery from Theory to Practice

Plenge Gen

When I last wrote about AI on this blog three years ago, I spoke of it being a tool with the potential to transform scientific discovery, but the application I described was primarily theoretical. … The post AI Unleashed: Transforming Drug Discovery from Theory to Practice appeared first on Plenge Gen @rplenge.

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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Altasciences at ARVO 2025: An Eye on the Future of Ophthalmic Drug Development by Gretchen Green

Alta Sciences

AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.

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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).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).