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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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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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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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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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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.