Featured content in this Issue: Companies, organisations and drug candidates mentioned in this Bulletin: EQUULUS Therapeutics; EQL-101; EQL-201; Gilgamesh Pharmaceuticals; DemeRx; atai Life Sciences; Delix Therapeutics; CaaMTech; Lykos Therapeutics; Beckley Psytech; BPL-003; Compass Pathways; Clairvoyant Therapeutics. This is the first issue of our Psychedelic Bulletin that’s exclusively… Source ..read more

On Tuesday the 16th and Wednesday the 17th of April, the European Medicines Agency (EMA) hosted a meeting in Amsterdam, “Multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework”. Heavy rain and strong winds earlier in the week stunted Schiphol Airport’s capacity, making it a bad trip for some. Still, those attendees that made it to Amsterdam included academics… Source ..read more

Featured content in this Issue: Companies, organisations and drug candidates mentioned in this Bulletin: Numinus Wellness; The Dales Report; Algernon Pharmaceuticals; AP-188; Seyltx; atai Life Sciences; IBX-210; DMX-1002; Seaport Therapeutics; Karuna; SPT-348; Otsuka; Click Therapeutics; Rejoyn; Lykos Therapeutics. This is the first issue of our Psychedelic Bulletin that’s exclusively… Source ..read more

Psychedelic Alpha’s Josh Hardman sits down with Jaskaran (‘Jaz’) Singh, Vice President Psychiatry Development at Neurocrine Biosciences. For the purposes of this conversation, however, we focus on Singh’s role in spearheading the development of esketamine for treatment-resistant depression, now marketed as Spravato. Here, we discuss how Singh’s early work assessing ketamine’s antidepressant… Source ..read more

Written by the Vicente LLP team as part of our Colorado Natural Medicine Health Act Tracker. On April 4, 2024, the Colorado General Assembly introduced Senate Bill 24-198, the first legislative update since the passing of SB 23-290 in 2023, which implemented the Natural Medicine Health Act. This relatively short bill clarifies… Source ..read more

Last month, psychedelic drug developer MindMed scored an FDA breakthrough therapy designation for its LSD-D-tartrate candidate (MM120) in the treatment of generalised anxiety disorder (GAD). The company is preparing to launch a Phase 3 program by year-end. (See FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder….) Notably… Source ..read more

Written by the Vicente LLP team as part of our Colorado Natural Medicine Health Act Tracker. The primary focus of the March 15th meeting of the Natural Medicine Advisory Board (“NMAB”) was to review, and provide its input on, stakeholder feedback received on draft rules for Facilitator licensing and training… Source ..read more

This is a special version of our Psychedelic News Feed to mark April 1st, 2024. ∎ Coming Soon: Interdimensional Patent Tracker Our friends at Calyx Law are involved in the first US patent application from a… Source ..read more

In this issue of the Psychedelic Patent Analysis, we look at IP and exclusivity in MDMA drug development across Lykos, atai, MindMed, Arcadia, and PharmAla. We also look at Terran’s allowed claims to certain psilocybin solid forms. We added 22 PCTs and 21 US patent applications focused on psychedelics to our tracker in February 2024. New entries came from the likes of Johns Hopkins… Source ..read more

Yesterday, the Institute for Clinical and Economic Review (ICER) published its draft evidence report on MDMA-assisted psychotherapy (which it abbreviates to ‘MDMA-AP’) for the treatment of PTSD. ICER is a nonprofit organisation that, in its own words, collaborates “with stakeholders across the US healthcare system [to] assess how much better a health intervention is, and what a fair price could be. Source ..read more