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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect.

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Scaling up: The need for human cells to give better access to cell therapies

Drug Discovery World

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

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From cradle to grave: Novo Nordisk Foundation and cardiometabolic diseases 

Drug Discovery World

million) over a five-year period for Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity (the PRE-STORK Trial). million) was awarded over a five-year period for the Pre-pregnancy Weight Loss and Reducing Childhood Overweight project (PREPARE CHILD), a randomised controlled trial. billion DKK ($11.97 million ($3.4

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Sequana Medical Appoints Two Additional Experts as Heart Failure Scientific Advisors

The Pharma Data

Pre-clinical and clinical proof-of-concept data from a first-in-human single dose DSR study demonstrated that single dose DSR therapy was safe and well-tolerated and the positive results were published in the high impact peer-reviewed cardiovascular journal, Circulation. and EU5 by 2026. About Dr. Udelson James E.

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Advances in neuroscience drug discovery

Drug Discovery World

For example, it can take up to it three years to recruit enough participants for a dementia clinical trial. years it takes to complete an entire cancer clinical trial. The organisation also notes that only 1% of the people that can take part in dementia clinical trials actually do so. This compares to the 2.3

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