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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.

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Highs and lows of drug repurposing 

Drug Discovery World

It’s common knowledge that drug discovery and development is costly, lengthy and has no guarantee of success. It’s why pharmaceutical companies will often spend up to 10 years and upwards of $1 billion before receiving regulatory approval for a drug.

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The Race for Ozempic Alternatives: Unlocking the Future of Weight Loss Medication

DrugBank

The Quest for Ozempic-Like Alternatives Ozempic, a GLP-1 receptor agonist developed by Novo Nordisk, has demonstrated remarkable efficacy in promoting weight loss and improving metabolic health. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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Pioneering access to complex generic products 

Drug Discovery World

For instance, the development team would have to perform a deep characterisation study to understand the goalpost and which formulation might be successful or which characteristics might influence the pharmacokinetic (PK) study while determining how the body handles the substance. Other significant challenges include: 1.

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Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

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Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

The Pharma Data

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. is a leading global pharmaceutical company headquartered in Japan. About Alzheimer’s Disease. About Eisai Co.,

Disease 40
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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. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.