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M&A outlook for pharma in 2025
For a strong 2025, dealmaking should be central to the life sciences strategy, says EY’s annual M&A report.
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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
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.
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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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Natural allopregnanolone made orally bioavailable
Designed to treat anxiety and postpartum depression, a biotherapeutics company has made natural allopregnanolone orally bioavailable without permanent chemical modification.
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
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.
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Canadian and US developers to trial psychedelic medicines in UK
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.
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Live from CPhI: ‘Gut microbiome therapy to be approved in the next two years’
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.
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Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
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How can evidence-based medicine (EBM) methodology support drug withdrawals?
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…
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EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
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Why it’s high time for psychedelic drug development
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.
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Positive effects of psychedelic microdosing likely due to placebo effect, finds study
The largest placebo-controlled psychedelics study to date concluded that the psychological benefits of microdoses of psychedelics are likely due to the placebo effect.
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Partnership to develop a microneedle patch for delivering psychedelic pharmaceuticals
The Terasaki Institute is partnering with PharmaTher to adapt a microneedle drug delivery patch for the micro-dosing of psychedelics.
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Fluvoxamine may prevent severe COVID-19 onset, suggests trial
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
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Cannabinoid series: developing a synthetic CBD tablet
Aubrey Dan explains how EmpowerPharm developed its synthetic CBD tablet and why a novel formulation could help combat a range of indications.
