Psychedelic News

Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration
MAPS Public Benefit Corporation (MAPS PBC) announced today that it has selected the contract research organisation (CRO), MMS Holdings (MMS), as its CRO for the development of a New Drug Application (NDA) for MDMA-assisted therapy for PTSD. MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project ...

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Published: 2022-06-27
Type: Press Release
A Psychedelic Renaissance at the V.A.
Psychedelics’ latest feature in The New York Times explores the work of four Veterans Affairs clinicians, frustrated with existing treatments for addiction and PTSD, and have turned to psychedelic medicine to help veterans get the treatment they need.
Published: 2022-06-24
Type: Popular Press
Cybin Receives FDA IND Clearance for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Potential Treatment of Major Depressive Disorder
Cybin has announced that it has received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analogue that is being developed for the potential treatment of major depressive disorder. This milestone marks the industry’s first-ever ...

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Published: 2022-06-27
Type: Press Release
Enosis Therapeutics Generates Positive Results from World's First Study of the Synergistic Application of Virtual Reality and Psychedelics
Enosis Therapeutics has announced the successful completion of the world’s first study on the synergistic application of VR and psychedelics. The study, led by researchers and co-founders of Enosis Therapeutics, Agnieszka Sekula and Prash Puspanathan, was conducted in the Netherlands and in collaboration with Swinburne University of Technology and the Psychedelic Society Belgium.
Published: 2022-06-15
Type: Press Release
U.S. FDA Clears MYCO-001 for Multi-Site Government Funded Trial in Smoking Cessation
Mydecine has announced that the U.S. Food and Drug Administration has cleared MYCO-001 in a recent Investigational New Drug (IND) application, marking the first clearance of the company’s drug product.
Published: 2022-06-17
Type: Press Release
Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression
Braxia Scientific has announced positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for treatment-resistant depression. Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study and clinically meaningful improvements in ...

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Published: 2022-06-02
Type: Press Release
Launch of the Psychedelic Access and Research European Alliance – PAREA
PAREA is a non-profit, multistakeholder and multidisciplinary partnership bringing together patient organizations, medical associations, scientific societies, psychedelic foundations, and the for-profit sector in an effort to change perceptions about psychedelic-assisted therapies, raise awareness of the scientific advances and, ultimately, bring better health to European citizens.
Published: 2022-06-13
Type: Healthcare
Cybin Receives Institutional Review Board Approval for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder
Cybin has announced that it has received Institutional Review Board approval to begin the first-in-human Phase I/IIa clinical trial evaluating CYB003, its proprietary deuterated psilocybin analogue, for the treatment of major depressive disorder.
Published: 2022-06-09
Type: Scientific / Research
How psychedelic drugs might treat depression
Psychedelics feature in the BBC yet again. This time, Clare Tweedy dissects how psychedelics can help to treat depression.
Published: 2022-06-07
Type: Popular Press
Let doctors use MDMA to treat veterans with PTSD and depression, former ADF boss says
The former chief of the Australian defence force, Chris Barrie, is campaigning to remove barriers stymying doctors from using MDMA to treat veterans suffering post-traumatic stress disorder and depression, saying he hopes “common sense is going to prevail”.
Published: 2022-06-03
Type: Popular Press
Tripp Raises Another $11 Million; Unity CEO's Metaverse Messaging
Tripp has raised $11.2 million in funding to help it continue to create meditation apps that power the “mindful metaverse.”
Published: 2022-06-01
Type: Scientific / Research
Cybin Announces Roster of 28 Expert Faculty and Advisors for its EMBARK Psychedelic Facilitator Training Program
Cybin has announced the team of 28 esteemed faculty and advisors who will lead the Company’s EMBARK Psychedelic Facilitator Training Program. Recognizing the crucial importance of supporting psychedelic study facilitators with quality training, Cybin has brought together recognized leaders and senior psychedelic-assisted psychotherapy trainers from leading universities and psychedelic research and training organizations.
Published: 2022-06-03
Type: Press Release
Awakn Life Sciences Initiates Follow-on Behavioral Study to Focus on Gambling Disorder
Awakn Life Sciences has announced that they have initiated a larger behavioral addiction study investigating ketamine as a treatment for Gambling Disorder. The larger study announced today will include 42 patients who are suffering from Gambling Disorder and will see participants undergo a memory reactivation procedure, which is designed to weaken the link between reward and ...

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Published: 2022-06-02
Type: Press Release
Ehave Inc. Announces Psychedelics Precision Medicine Platform For Clinical Research
Ehave Inc. has announced that its KetaDASH subsidiary will begin using precision medicine to improve patient outcomes through its partnership with Entheon Biomedical Corp.’s wholly-owned subsidiary, HaluGen Life Sciences. KetaDASH will become one of the first psychedelic companies to use precision medicine to test patients by using HaluGen’s expanded psychedelics genetic testing panel, which analyzes ...

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Published: 2022-06-01
Type: Press Release
Lennham Pharmaceuticals Announces Issuance of U.S. Patent Covering Methods of Administering Psilocybin and Psilocin
Lennham Pharmaceuticals has announced that the United States Patent & Trademark Office issued U.S. Patent No. 11,344,564 with an expiration date of December 2041. This patent covers methods of treating neurological or psychiatric disorders in patients having reduced monoamine oxidase A (MAO-A) activity by administering a below-normal dose of psilocybin or psilocin.
Published: 2022-05-31
Type: Press Release
Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder
Cybin has announced that it has submitted an Investigational New Drug application to the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003, a proprietary deuterated psilocybin analogue, for the treatment of major depressive disorder.
Published: 2022-05-31
Type: Press Release
Optimi Health Enters Into Psilocybin Supply Agreement With Filament Health
Optimi Health has been engaged by Filament Health to supply psilocybin mushrooms cultivated in Optimi’s recently inaugurated 20,000 square foot EU-GMP Princeton, British Columbia facility in the form of whole, dried mushroom fruiting bodies for potential drug development, testing, and analysis by Filament’s research team.
Published: 2022-05-31
Type: Press Release
‘We spark curiosity’: how the psychedelics industry is taking on Davos
In this piece for The Guardian, Josiah Hesse gives us an insight into exactly what went on at “The Psychedelic House of Davos.”
Published: 2022-06-01
Type: Popular Press
Albert Labs Appoints Principal Investigator for Real World Evidence Study for KRN-101
Albert Labs has announced Sara Tai, Senior Lecturer in Clinical Psychology from Manchester University, as Principal Investigator for its upcoming trial. The trial will evaluate the safety and efficacy of KRN-101, a psilocybin-based medicine, for the treatment of cancer-related distress.
Published: 2022-05-26
Type: Press Release
Ceruvia Lifesciences Submits FDA Investigational New Drug Application for Psilocybin Obsessive-Compulsive Disorder Program
Based on a positive pre-IND meeting with the U.S. FDA, Ceruvia Lifesciences has submitted an Investigation New Drug (IND) application to begin a Phase II clinical trial for the treatment of obsessive-compulsive disorder with psilocybin Preliminary results from the Ceruvia funded pilot Phase II study taking place at Yale School of Medicine demonstrate rapid and robust improvement ...

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Published: 2022-05-24
Type: Press Release
Clerkenwell Health Taps Top Academics and Expands Pan-European Scientific Advisory Board
Clerkenwell Health has announced the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone to its advisory board from Danish, Dutch and British universities.
Published: 2022-05-26
Type: Press Release
Oregon Psilocybin – Administrative Rules
The Oregon Health Authority (OHA) has adopted the first subset of rules related to psilocybin products, testing and training programs. These rules are needed to implement ORS chapter 475A, the Oregon Psilocybin Services Act. The rules specify curriculum requirements for programs planning to train people interested in facilitating psilocybin services in Oregon, as well as initial ...

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Published: 2022-05-23
Type: Regulatory
Psychedelics In Davos? Jason Silva Explains What’s Happening During The World Economic Forum
This great article from Jason Silva for Forbes details what exactly is happening at the World Economic Forums’ annual meeting in Davos in relation to psychedelic medicine.
Published: 2022-05-20
Type: Popular Press
$2.7M Grant to UC Davis to Find New Addiction Treatments Related to Psychedelics
Researchers at the University of California, Davis, and the University of Colorado Anschutz Medical Campus plan to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. The research is funded by a $2.7 million grant from the US National Institute on Drug Abuse.
Published: 2022-05-23
Type: Scientific / Research
COMPASS Pathways presents the largest ever study of psilocybin therapy, at the American Psychiatric Association annual meeting
COMPASS Pathways has presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after ...

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Published: 2022-05-23
Type: Press Release
THE FIRST-EVER MEDICAL PSYCHEDELICS SERIES AT DAVOS 2022 hosted by Energia Holdings Incorporated
As world leaders come together to discuss the global economy at the World Economic Forum’s annual gathering, the world’s most prominent psychedelic industry leaders, drug development experts, clinicians, nonprofit organizations, advocates, and influencers will gather separately in Davos at the inaugural Medical Psychedelic Series to help shape the future of mental health.
Published: 2022-05-18
Type: Press Release
MAPS Completes Enrollment, as Planned, for the Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD
MAPS has announced that a blinded administrative interim analysis has confirmed no changes to the planned sample size are necessary to provide sufficient statistical power to detect the efficacy of MDMA-assisted therapy for PTSD in the second of two Phase III trials. Per their agreement with the FDA, the Phase III trial was designed to ...

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Published: 2022-05-09
Type: Press Release
Emotional Intelligence Ventures and Mycotopia enter a Definitive Agreement on $382M merger transaction
Ei Ventures has executed a definitive agreement with Mycotopia bringing the two entities together under PSLY.com as the companies move forward with their plan of uplisting to the NASDAQ stock exchange. Ei shareholders will receive shares in PSLY.com based upon a valuation of $360 Million at the close of the transaction. Mycotopia shareholders will receive ...

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Published: 2022-05-19
Type: Press Release
CSIRO starts work on medicinal psychedelics
CSIRO, Australia’s national science agency, is aiming to develop new psychedelics to help people with a variety of mental health issues including depression, addiction, end of life anxiety and PTSD. Under a new license, CSIRO will work with local MedTech companies to improve existing psychedelic products and develop new ones.
Published: 2022-05-18
Type: Scientific / Research
Inside the Dispute Over a High-Profile Psychedelic Study
The latest article from Shayla Love at Vice gives us an insight into a very public dispute on the methods and claims made in this recent study by some prolific psychedelic scientists.
Published: 2022-05-16
Type: Popular Press

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