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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

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

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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

The publication confirms that Ozempic accounted for 41% of Novo’s total sales in 2023, equivalent to nearly $14 billion, with two-thirds of the drug’s sales coming from the United States. billion DKK ($11.97 Wegovy brought in sales of about $4.5 When this was launched in September 2021, it was supported by a grant of up to $47.5

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Advances in neuroscience drug discovery

Drug Discovery World

Lu Rahman looks at neuroscience drug discovery – advances and challenges – and how breakthroughs in this field are helping address areas of unmet need. Recent advances in biomarkers, research into the central nervous system and breakthroughs in human iPSC cell models, have bolstered neuroscience drug discovery research.

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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.