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In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
Designed to treat anxiety and postpartum depression, a biotherapeutics company has made natural allopregnanolone orally bioavailable without permanent chemical modification.
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
Canadian and US developers of psychedelic medicines for complex mental health conditions have signed with a UK-based CMO to trial their drugs in London.
The promise of microbiome-based therapeutics is rapidly progressing towards real world applications as treatment of recurrent Clostridium difficile using faecal microbiota transplant edges towards a BLA.
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
Here, Dr Matthew McMurray and Dr J Andrew Jones of Miami University explain why psychedelic drugs are attracting R&D as potential treatments for neuropsychiatric and degenerative disorders and how their discovery of an in vivo production technique could enable further advancement.
The largest placebo-controlled psychedelics study to date concluded that the psychological benefits of microdoses of psychedelics are likely due to the placebo effect.
The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
Aubrey Dan explains how EmpowerPharm developed its synthetic CBD tablet and why a novel formulation could help combat a range of indications.
During the COVID-19 pandemic, when many are in lockdown or self-isolating, mental health could suffer. This article suggests some ways to stay healthy over this period.
