Insights

Read our independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

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The latest

Pα+ Psychedelic Bulletin #182: Psychedelics Insiders’ Trump 2.0 Wishlist; Doblin Reflects on Lykos’ Strategy; Polish Psilocybin Study Scores $4M in Funding

December 10, 2024

Psychedelics Insiders Draw Up Trump 2.0 Wishlist • Rick Doblin Reflects on Lykos’ Strategy as MAPS Settles with FDA • Polish Medical Research Agency Set to Provide PLN 16M ($4M) to Psilocybin Study • VA Issues Note on Psychedelics for PTSD; Officially Funds Psychedelics Study • Alleged Killer of UnitedHealth CEO Apparently Interested in Psychedelics • and more…

Inside the FDA’s Psychedelics Journey: Javier Muniz, MD on Breakthroughs, Challenges, and the Future of the Field

December 5, 2024

In our latest Pα+ interview, our Editor Josh Hardman speaks with Javier Muniz, MD, who recently left his post as Associate Director at the FDA’s Division of Psychiatry. In that role, Muniz was at the heart of the agency’s psychedelics learning journey and helped formulate its view on thorny topics in psychedelic drug development like functional unblinding and the role of psychotherapy. This interview is far-reaching and provides a unique look into both the mind of the regulator, but also Muniz’s own views on psychedelics, now that he is unencumbered by his position in the agency.

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The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

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Pα+ Library: Bifurcated Scheduling

December 6, 2023

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

November 15, 2023

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

The Psychedelic News Feed Archives

Archived versions of our Psychedelic News Feed.

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