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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 131
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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults.

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

Lenacapavir for PrEP was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in October. This newly released data was presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103
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Two novel biosimilars approved in EU and US

European Pharmaceutical Review

Eculizumab biosimilar gets positive CHMP opinion The post Two novel biosimilars approved in EU and US appeared first on European Pharmaceutical Review.

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Patents: a necessary evil?

European Pharmaceutical Review

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.