Issue 163

Europe to establish regulatory guidance on psychedelics in 2024

The European Medicines Agency (EMA) is set to hold a multi-stakeholder workshop on medical psychedelics in April 2024 to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.

In what marks an important next step for psychedelics in Europe, the workshop – Towards an EU regulatory framework – will bring together patients, healthcare professionals, academia, regulators and industry.

The workshop will cover research methodology, regulatory processes and requirements and the relevance of real-world data, and aims to:

  • Hear the views of stakeholders and experts on the therapeutic potential of psychedelics;
  • Provide further clarity on defining the safe and effective use of psychedelics;
  • Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
  • Define areas for which further regulatory guidance is required.
READ MORE

PSYCHEDELIC THERAPY MAY HELP BREAK THE CHAINS OF GAMBLING ADDICTION

Researchers at Imperial’s Centre for Psychedelic Research are using brain imaging to understand addictions and devise new approaches to treating them.

The researchers are looking at new ways of setting the hijacked brain free, using psychedelic substances such as psilocybin.

Read More

PSYCHEDELICS GAVE TERMINAL PATIENTS RELIEF FROM THEIR INTENSE ANXIETY

End-of-life cancer patients in a therapy group in Canada used psilocybin to reduce their fears. It helped some find peace.

The Washington Post explores the experiences of patients who have been given access to psychedelic-assisted psychotherapy under Canada’s Special Access Programme.

Read More

BUSINESS AND INVESTMENT

Compass Pathways has entered into a research collaboration with Hackensack Meridian Health to develop an optimal clinical model for investigational COMP360 psilocybin treatment, if FDA-approved.

MAPS has reintroduced its Fiscal Sponsorship Program which will provide support for grassroots organisations within the psychedelic ecosystem.

Psyence Group subsidiary, Psyence Biomedical, has entered into a securities purchase agreement for up to US$10 million through issuing up to four senior secured convertible notes with a US-based investment firm.

Red Light Holland has received a building permit for AEM Farms 80,000 square foot mushroom farm, adding substantial future production capacity.

SCIENCE AND RESEARCH

Medicinal chemists at Usona Institute have designed a series of new compounds inspired by norpsilocin, a tryptamine natural product found in psychedelic mushrooms.

Singularity Hub discusses findings from a new study that has offered insights into how psychedelics can rapidly fight depression.

A systematic review of Modern Psychedelic Microdosing Research on Mental Health has been published which aims to understand if microdosing can improve mental well-being.

NPR explores how pioneering anthropologist Margaret Mead’s research into utopias helped usher in the psychedelic era.

REGULATION AND LEGISLATION

A California bill is paving the way for psychedelic therapy after failure to legalise ‘magic mushrooms’, reports the Los Angeles Times.

Politico explores how state legislatures are considering bills this year to decriminalise psychedelics or legalise them for therapeutic use.

ARTICLES OF INTEREST

More than 40,000 people with mental health problems are being supported back into employment thanks to an NHS programme.

A new paper has found an ancient polymorphic regulatory region within the BDNF gene associated with obesity modulates anxiety-like behaviour.

Partner with us