Elementor #8561 - Psychedelic Alpha

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Insights from the European Medicines Agency’s Psychedelics Workshop: A Pα+ DispatchApril 23, 2024
Last week, the EMA hosted a meeting in Amsterdam, “Multi-stakeholder workshop on psychedelics - Towards an EU regulatory framework”. In this Pα+ Dispatch, Josh explores some of the key themes discussed at the workshop: from regulatory remits and rescheduling through to disentangling pharmacotherapy from psychotherapy, standardisation and its discontents, blinding, and much more.
Pα+ Psychedelic Bulletin #161: Numinus Shifts Focus to US; Algernon Makes DMT for Stroke Lead Asset; atai Pivots to IV IbogaineApril 17, 2024
Numinus’ Shifting Focus Toward U.S. Market Revealed via “Unauthorized Disclosure” • Algernon Pharmaceuticals Makes DMT Stroke Research Program Its Lead Asset • atai Pivots to IV Formulation of Ibogaine • Seaport Therapeutics Launches with $100m Series A, Pipeline Includes ‘Prodrug of a Non-Hallucinogenic Neuroplastogen’ • and more...
Developing Esketamine (Spravato) and Lessons for Psychedelic Drug Developers with Jaskaran SinghApril 12, 2024
Josh Hardman sits down with Jaskaran (‘Jaz’) Singh, who spearheaded the development of esketamine for treatment-resistant depression, now marketed as Spravato. We discuss how Singh’s early work assessing ketamine’s antidepressant effects at the National Institute of Mental Health (NIMH) encouraged him to move into industry; how his team decided to pursue esketamine; lessons learned that might be relevant for psychedelic drug developers; and his broader outlook on the field.
Natural Medicine Advisory Bulletin 10.1: Legislative UpdateApril 9, 2024
Vicente LLP reviews Senate Bill 24-198, the first legislative since the passing of SB-23-290 in 2023, which implemented the Natural Medicine Health Act.
MindMed’s ‘Total Elimination’ of Psychotherapy in LSD Study Stokes Debate Around Its Role in Psychedelic TherapiesApril 5, 2024
In March, MindMed scored an FDA Breakthrough Therapy Designation for its LSD-D-tartrate candidate (MM120) for generalised anxiety disorder (GAD). Here, Josh takes a closer look at the company's claim to have ‘eliminated’ psychotherapy from its Phase 2b study of MM120 and explores how a ‘Spravato-isation’ of psychedelic therapies is stoking broader debates around the contribution of psychotherapy in psychedelic therapies or ‘treatments’.

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