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The future of medical cannabis development in Europe

European Pharmaceutical Review

1 Europe, however, is well placed to become a leader in driving the clinical translation of medications that display significant promise in laboratory-based studies. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

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Zydus receives USFDA approval to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

Express Pharma

Zydus has previously completed a Phase 2(a) randomised, double-blind, placebo-controlled clinical trial in 24 ALS patients across 7 clinical trial sites in India. It is planned to present this Phase 2(a) trial data in an upcoming medical conference and publish in a medical journal. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318.

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Developing new treatment regimens for HIV

European Pharmaceutical Review

For more than 15 years, integrase strand transfer inhibitors (INSTIs) have served as the foundation of ART regimens in HIV treatment guidelines around the world and our present portfolio is built on them. With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety.

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FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

FDA Law Blog: Biosimilars

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. When a comprehensive neurodevelopmental evaluation is needed, it should include an evaluation of physical, mental, and social health.