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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

What sponsors should know about psychedelic drug development. Although some psychedelics have a long history in traditional medicine, regulatory agencies must evaluate psychedelic compounds the same way they assess any other drug. Psychedelic compounds are assessed by regulators the same way as any other drug.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful.

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Drug Discovery and Development

RX Note

Introduction Drug development is an expensive and lengthy process , taking about 2-3 billion dollars and over 10 years to discover and develop a drug to commercialization. Drug Development Timeline Discovery and Development Research for a new drug begins in the laboratory.

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Why relationships are key in rare disease patient engagement

pharmaphorum

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards. He says he would like to see the industry engaging rare disease patients at every stage of drug development.

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Novartis licenses cocaine use disorder therapy to Stalicla

pharmaphorum

It also has potential in NDD, although it was discontinued as a treatment of fragile X syndrome in 2014 after disappointing phase 2b trial results. The market potential of the CUD and NDD indications alone could top 2 billion euros ($2.12 billion) globally, the company noted. Lynn Durham.

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014. The Role of Master Protocols in Pediatric Drug Development. Ther Innov Regul Sci.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author.