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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Worldwide Clinical Trials

Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials. Aside from the obvious complexities of managing a drug that alters the mind, the regulatory and ethical nuances can hold ill-prepared developers back.

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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s widespread support for the project. “We The Clamp2 trial group showed a 2.5-fold fold boost in neutralising ‘titres’ and it was 2.1

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Why are clinical trials struggling with diversity?

pharmaphorum

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go.

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What Drives Clinical Trial Costs? A Comprehensive Exploration

Cloudbyz

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Biogen licenses Denali’s amyloid beta programme for Alzheimer’s

Pharmaceutical Technology

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. Under the terms, Biogen will handle all the development and commercial activities of ATV: Aβ, along with the related expenses.

Licensing 130
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Can technology help diversify clinical trials?

pharmaphorum

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.