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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FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized.

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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) to the academy. On the other hand, the Novo Nordisk Foundation Center for Basic Metabolic Research aims to deliver world-class research in tackling some of today’s biggest health challenges. billion DKK ($11.97 Following its inception, the Novo Nordisk Foundation awarded a grant of DKK 150 million ($21.46 million).

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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.

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Advances in neuroscience drug discovery

Drug Discovery World

According to Alzheimer’s Research UK (ARUK): “In the UK, dementia was the leading cause of death in 2022 and has been the leading cause of death for women since 2011 – maintaining its position throughout the Covid-19 pandemic. Dementia is the only major cause of death without a treatment to prevent, slow or stop disease progression. “In

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