Psilocybin

Optimi Health Signs Psilocybin Supply Agreement With New Zealand-Based Mātai Medical Research Institute

Retrieved on: 
Tuesday, April 9, 2024
Psilocybin, First Nations, Wharerātā, Certificate, Patient, Ethics, FRA, COA, Synthetic, Health Canada, Trial of the century, GMP, Clinical trial, Ground substance, Safety, MDMA, Medsafe, Medicine, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.
  • This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts.
  • Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract.
  • Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance.

HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

Retrieved on: 
Tuesday, April 9, 2024
Certification, Therapeutic Goods Administration, DEL, Sale, Psilocybin, IND, GMP, Cannabis, Investigational New Drug, Drug development, TGA, FDA, PIC/S, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.
  • The audit, which aims to expand the Company's Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN's Kelowna production facility by Australia's Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
  • Securing a DEL will enhance HYTN's current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations.
  • HYTN has demonstrated its ability to manufacture these products according to GMP guidelines.

Optimi Health Receives Finished Product Test Results and Certificate Of Analysis for GMP Natural Psilocybin Extract

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, Psilocybe, Organization, Documentation, Learning, Certificate, Patient, Research, Good manufacturing practice, FRA, COA, International Council, Health Canada, GMP, Data collection, Quality, Harmonization, Ground substance, GACP, Water, Safety, ICH, MDMA, Good

Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.

Key Points: 
  • Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.
  • The third-party COA confirms critical information regarding potency, water content, microbial content, and heavy metal content, ensuring that the Natural Psilocybin Extract meets the predetermined specifications.
  • The completion of both extract validation and finished product testing aligns with Optimi's goal of advancing the drug candidate, marking significant progress toward its eventual release for human consumption.
  • “Obtaining successful results on the validation batches of psilocybin extract speaks to Optimi’s dedication to developing a repeatable, quality focused manufacturing process.

Revive Therapeutics Provides Update on Psilocybin Clinical Study for Methamphetamine Use Disorder

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, Methamphetamine, Public health, Psychotherapy, Research, Mortality, University, RVV, DSM-IV codes, IND, Safety, Therapy, Disorder, OTCQB, Study, School, Pharmaceutical industry

The Study has enrolled nearly 50% of its intended study sample, with initial efficacy being encouraging.

Key Points: 
  • The Study has enrolled nearly 50% of its intended study sample, with initial efficacy being encouraging.
  • The clinical data generated from the Study may provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support a potential pivotal clinical study and commercial initiatives in countries, such as Australia, where psilocybin can be available to licensed psychiatrists to prescribe for certain conditions.
  • Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical, and social harms and increasing rates of mortality.
  • At present, there are no approved medications to treat methamphetamine use disorder.

PsyCan Welcomes Expansion of Insurance Coverage for Psychedelic-Assisted Therapy in Alberta

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, FAQ, Therapy, LSD, COVID-19, Patient, PAT, DMT, Private sector, Doctor of Philosophy, Insurance, Psychology, MDMA, FDA, Nursing

OTTAWA, April 02, 2024 (GLOBE NEWSWIRE) -- PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine industry, welcomes the expansion of insurance coverage for psychedelic-assisted therapy (PaT) led by the Alberta Blue Cross.

Key Points: 
  • OTTAWA, April 02, 2024 (GLOBE NEWSWIRE) -- PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine industry, welcomes the expansion of insurance coverage for psychedelic-assisted therapy (PaT) led by the Alberta Blue Cross.
  • “We welcome Alberta Blue Cross as the first major provincial insurer to cover Psychedelic-Assisted Therapy in all of its forms,” said Philippe Lucas, PhD, President of SABI Mind, a psychedelic clinic group based in Alberta.
  • In fall 2022, Alberta became the first province to regulate psychedelic-assisted therapy for mental health treatments, and in a recent FAQ to healthcare providers, the Alberta Blue Cross explained that claims for psychedelic therapy in Alberta are eligible for reimbursement under plan members’ drug and psychology benefits.
  • We call on other insurers, both in the public and private sector to follow the example set by Alberta Blue Cross.”

atai Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate and Clinical Highlights

Retrieved on: 
Thursday, March 28, 2024
Research, Depression, Congress, PD, Patient, OUD, CIAS, Sale, G&A, DMT, Șaeș, Pivotal, Psilocybin, Atai, TRD, Investment, Ibogaine, Pharmacokinetics, Safety, PTSD, OTF, Pharmaceutical industry

“In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need.

Key Points: 
  • “In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need.
  • In November 2023, atai acquired all remaining outstanding shares of its subsidiary, DemeRx IB, Inc., streamlining clinical, general and administrative operations.
  • atai realized operational efficiencies by simplifying and optimizing its organizational structure in line with its revised business and pipeline priorities.
  • In August 2023, the Phase 1 study results demonstrated that 9 mg/kg of oral ibogaine leads to robust psychedelic experiences.

Compass Pathways Board Chair and Co-Founder George Goldsmith and Co-Founder Ekaterina Malievskaia Step Down from Board of Directors

Retrieved on: 
Thursday, March 28, 2024
Patient, Chairperson, CNS, Mental health, Innovation, CMPS, Psilocybin, TRD, Johnson & Johnson, Operation, Pain, KCL, Frustration, J&J, Food, Nursing

David Norton, lead independent director on the Compass board of directors, will become interim chair.

Key Points: 
  • David Norton, lead independent director on the Compass board of directors, will become interim chair.
  • Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
  • “When we started Compass eight years ago, we could not have imagined how the company would grow and mature,” said George Goldsmith, outgoing board chair of Compass Pathways.
  • He has been a member of the Compass board of directors since 2018, serving as lead independent director.

Psyence Group Announces the Closing of the Previously Announced Strategic Restructuring of Its Non-Clinical Business

Retrieved on: 
Tuesday, March 26, 2024
The Company, Disease, Research, News, Nature, Health Canada, Psilocybin, OTC, Safety, Transaction, Food

Psyence has built a network of potential clients and customers, and successfully and lawfully distributed psilocybin internationally, both itself and via its strategic partners.

Key Points: 
  • Psyence has built a network of potential clients and customers, and successfully and lawfully distributed psilocybin internationally, both itself and via its strategic partners.
  • Psyence will play a vital role in ensuring the commercial success of the Transaction target non-clinical assets and business and will continue exploring new markets for medical grade psilocybin and active pharmaceutical ingredients.
  • Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively the "Company") are forward-looking statements and are prospective in nature.
  • If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

Synaptogenix Increases Stake in Innovative Psilocybin Drug Discovery Company through its Partnership with Cannasoul Analytics

Retrieved on: 
Tuesday, April 9, 2024
Psilocybin, Alzheimer's disease, Partnership, Research, Parkinson's disease, Inflammatory bowel disease, Therapy, Intellectual property, Bryostatin, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that it has increased its stake in psilocybin drug discovery company PsygaBio through its previously announced partnership with Cannasoul Analytics ("Cannasoul"). Synaptogenix acquired a 25% stake in Cannasoul during November of 2023 in support of research and development for psilocybin mushroom and cannabinoid-based therapeutics. Cannasoul is founded by the Technion Research & Development Foundation, the commercialization arm of The Technion—Israel Institute of Technology ("the Technion").

Key Points: 
  • NEW YORK, April 9, 2024 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that it has increased its stake in psilocybin drug discovery company PsygaBio through its previously announced partnership with Cannasoul Analytics ("Cannasoul").
  • Synaptogenix acquired a 25% stake in Cannasoul during November of 2023 in support of research and development for psilocybin mushroom and cannabinoid-based therapeutics.
  • Cannasoul is founded by the Technion Research & Development Foundation, the commercialization arm of The Technion—Israel Institute of Technology ("the Technion").
  • Synaptogenix, through its partnership with Cannasoul, expanded its stake in PsygaBio, enabling Synaptogenix Chairman Josh Silverman and Director Bruce Bernstein to join PsygaBio's board of directors.

HYTN Secures GMP Certification

Retrieved on: 
Thursday, March 21, 2024
Certification, Growth, Therapeutic Goods Administration, Good manufacturing practice, Psilocybin, GMP, Cannabis, TGA, Drug

VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.

Key Points: 
  • VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.
  • Effective March 15th, 2024, this certification enables HYTN to manufacture cannabis dried flower into bulk and finished GMP medical products.
  • Although the company has previously serviced limited export opportunities, compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products through this new GMP certification now enables HYTN to engage in broader international trade.
  • It also coincides with the emergence of a brand new and sizable market in Germany, also requiring GMP certification for medicinal cannabis products.