MDMA

Optimi Health To Host MDMA Educational Quality Assurance Webinar For Clinicians And Practitioners

Retrieved on: 
Tuesday, February 6, 2024
PTSD, Chase, Research, FRA, Quality assurance, Safety, Psilocybin, PST, FDA, MDMA, Food, Trust, Health, Lycus, GMP, NDA, Pharmacist, Pharmaceutical industry

VANCOUVER, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi”), a licensed Canadian drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, is announcing an informative webinar titled “Know Your Drug Candidate: Safeguarding Quality in Psychedelic Therapy.” This event, scheduled for Tuesday, February 13, 2024, at 2:00 p.m. Pacific Standard Time (PST), is a crucial opportunity for clinicians, scientists, researchers, therapists, pharmacists, and regulators involved or interested in the GMP manufacturing of psychedelic drug substances.

Key Points: 
  • Optimi Chief Science and Quality Assurance experts to provide in-depth access into the Company’s safety and quality standards.
  • Optimi experts will address critical inquiries which still exist on the definition of validated GMP psilocybin, MDMA, and other psychedelic substances.
  • Optimi is the only end-to-end, publicly listed psychedelics company currently offering its drug candidates at scale to address accessibility through lower costs.
  • Both individuals, considered experts in their respective fields, currently lead the Company's cutting-edge science and quality assurance divisions.

Clarion Clinics Open for Psychedelic-Assisted Treatments

Retrieved on: 
Thursday, February 1, 2024
PTSD, Post-traumatic stress disorder, Clarion, TGA, Prohibition of drugs, Therapeutic Goods Administration, Clinical trial, Environment, Patient, Safety, Depression, Psilocybin, TRD, MDMA, Authorization, Psychotherapy, Schedule, Pharmaceutical industry

MELBOURNE, Australia and NEW YORK, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc (Nasdaq: IXHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs is pleased to announce that Clarion Clinic’s co-Founder and Head of Psychiatry, Professor Suresh Sundram, has received Authorised Prescriber approval from the Therapeutic Goods Administration (TGA) to prescribe MDMA in the treatment of Post-traumatic Stress Disorder (PTSD) and psilocybin for Treatment-resistant Depression (TRD) at its first built-for-purpose clinic based in Melbourne, Australia, a city of approximately 5.2M people.

Key Points: 
  • Clarion Clinics’ built-for-purpose clinic in Melbourne is now open for treatment, and will begin screening patients immediately.
  • Clarion Clinics is a collaboration between Australia’s leading psychedelic-assisted therapy professionals and scientists, and Incannex.
  • Clarion Clinics, Abbottsford, will be the first dedicated psychedelic-assisted therapy clinic in Australia.
  • Clarion is at the leading edge of mental healthcare, has the right protocols, and an experienced team ready to help people through these challenging conditions,” Peter Widdows, Incannex Director responsible for Clarion Clinics, said.

PharmAla releases Profitable Q1 Interim Financial Statement and Business Update

Retrieved on: 
Wednesday, January 31, 2024
PTSD, Prohibition of drugs, Research, History, Substance, CDSL, MDXX, Patient, FDA, Authorization, OTC, MDMA, Health Canada, IP, Post-traumatic stress disorder, Bank statement, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.
  • PharmAla showed a quarterly profit for the first time in its history, validating its low-overhead manufacturing business model.
  • PharmAla believes that this is the first quarterly profit for any publicly-traded psychedelics company.
  • PharmAla will be hosting an investor webinar on Friday the 2nd to further elaborate on its financial report as well as discuss their recent achievement of obtaining a Controlled Drugs & Substances Dealer’s License (CDSL) from Health Canada.

PharmAla granted a Controlled Drugs & Substances Dealer’s License by Health Canada

Retrieved on: 
Thursday, January 25, 2024
Psilocybin, MDMA, Patient, Research, Science, SAP, Prohibition of drugs, Sale, Substance, OTC, Special access program, CDSL, Access, MDXX, Health Canada, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 25, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has been granted a Controlled Drugs & Substances Dealer’s License (CDSL) by Health Canada, Canada’s federal health regulator.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 25, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it has been granted a Controlled Drugs & Substances Dealer’s License (CDSL) by Health Canada, Canada’s federal health regulator.
  • The CDSL allows PharmAla to offer for sale both 3,4 Methylenedioxymethamphetamine (MDMA) and Psilocybin to those authorized to legally hold these materials.
  • “PharmAla is breaking new ground in the Canadian market.
  • “This license could drive revenue growth for the Company, and allow us to educate potential prescribers on the relevant science behind LaNeo™ and MDMA Therapy.

PharmAla receives new “MDXXF” ticker from FINRA for OTCQB Listing

Retrieved on: 
Wednesday, January 24, 2024
Attention, MDMA, OTC, Research, FDA, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 24, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel derivatives of MDMA (MDXX class molecules), is excited to announce its new OTC ticker, “MDXXF”, which will go into effect on January 24th.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 24, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel derivatives of MDMA (MDXX class molecules), is excited to announce its new OTC ticker, “MDXXF”, which will go into effect on January 24th.
  • “The new ticker symbol more closely aligns with our business model, the research, development and manufacturing of MDXX class molecules,” said Nick Kadysh, CEO, PharmAla Biotech.
  • “With less than a month to go before FDA is set to announce its assessment approach for MDMA as a therapeutic molecule, and with PharmAla’s globally leading position as an MDMA and MDXX developer, we are more excited than ever for the attention we will be receiving from US audiences in the next few months.”
    PharmAla will release its Q1 financial statements on January 29th, 2024.
  • For more information, please visit www.PharmAla.ca , where you can sign up to receive regular new updates.

Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence

Retrieved on: 
Friday, January 19, 2024
MDMA, DMF, Health, Part, Annual Review, Documentation, API, GMP, Communication, Food, Drug Master File, MDA, Health Canada, Ground substance, DEL, FRA

Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Key Points: 
  • Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.
  • Terms of the amendment now permit the following increases:
    N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE (MDMA) – from 2kg to 20kg.
  • It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances."
  • Optimi now has Health Canada approval to manufacture the following controlled substances:

VA Signals Historic Policy Shift By Funding First-Ever Psychedelic Studies for Veterans

Retrieved on: 
Monday, January 8, 2024
Veteran, Public policy, Policy, Research, Depression, FDA, Hope, Psilocybin, Member, Congress, MDMA, PTSD, Investment, RFA, Diagnosis, Skin, Suicide, House, Pharmaceutical industry

WASHINGTON, Jan. 8, 2024 /PRNewswire/ -- Last Friday, the Department of Veterans Affairs issued a Request for Applications (RFA) to study the use of FDA-designated Breakthrough Therapies, including MDMA-Assisted Therapy and psilocybin, to treat veterans who suffer from PTSD and depression. This announcement marks the VA's first-ever direct investment in support of these studies, and signals a significant policy shift in favor of MDMA and psychedelic-assisted therapies within the VA health care system. The VA's announcement marks a huge victory for the leading federal veteran advocacy group for MDMA-Assisted Therapy, Healing Breakthrough.

Key Points: 
  • VA issues Request for Applications (RFA) to study the efficacy of psychedelic compounds in treating veterans who suffer from PTSD and depression.
  • This announcement marks the VA's first-ever direct investment in support of these studies, and signals a significant policy shift in favor of MDMA and psychedelic-assisted therapies within the VA health care system.
  • The VA's announcement marks a huge victory for the leading federal veteran advocacy group for MDMA-Assisted Therapy, Healing Breakthrough.
  • The VA's decision to put skin in the game by funding veteran-specific studies on MDMA and psychedelics is more than just a historic event for those like me who recognize these compounds' life-saving potential.

PharmAla-1 Molecule Receives US Patent Prosecution Highway Acceptance

Retrieved on: 
Monday, January 8, 2024
MDXX, Conference, Partnership, PPH, PCT, Research, Patent, MDMA, University, Innovation, Patient, Safety, P-1, OTC, United States patent law, Pharmacology, Patent Cooperation Treaty, Pharmaceutical industry

“The dawn of MDMA as a therapeutic molecule is just beginning, and while we are actively working to treat patients with that molecule, we are also looking towards a future with novel molecular assets,” said Nick Kadysh, CEO, PharmAla Biotech.

Key Points: 
  • “The dawn of MDMA as a therapeutic molecule is just beginning, and while we are actively working to treat patients with that molecule, we are also looking towards a future with novel molecular assets,” said Nick Kadysh, CEO, PharmAla Biotech.
  • “P-1 is one of a number of next-generation assets which we are developing, and which promise to bring together both increased safety, and highly beneficial effects like increased neuroplasticity.”
    The Patent Prosecution Highway (PPH) speeds up the examination process for corresponding applications filed in participating intellectual property offices.
  • Under PPH, participating patent offices have agreed that when an applicant receives a ruling from a first patent office indicating that at least one claim is allowable, the applicant may request fast track examination of corresponding claims.
  • Proof-of-concept testing for P-1 showed significant efficacy and pro-social effect at dosage levels far lower than MDMA, PharmAla’s primary comparator molecule, as well as excellent safety pharmacology.

SciSparc and Clearmind Medicine Reflect on Successful Collaboration in 2023 Aiming to Upgrade Wide Range of Psychedelic-Based Treatments

Retrieved on: 
Thursday, January 4, 2024
TEL, Psilocybin, Patent, CWY, MDMA, LSD, Lysergic acid diethylamide, IP, PEA, Central nervous system, Patient, Safety, Therapy, Disorder, DMT, Pharmaceutical industry

TEL AVIV, Israel, Jan. 04, 2024 (GLOBE NEWSWIRE) --  SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, reflects on the successful collaboration in 2023 with  Clearmind Medicine Inc. (“Clearmind") (Nasdaq: CMND) (CSE: CMND) (FSE: CWY), a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems. Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office (USPTO) for unique combinations of future psychedelic-based compounds, as part of its ongoing collaboration with SciSparc.

Key Points: 
  • Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office (USPTO) for unique combinations of future psychedelic-based compounds, as part of its ongoing collaboration with SciSparc.
  • The patent applications are for novel proprietary combinations of lysergic acid diethylamide (LSD), psilocybin, N,N-dimethyltryptamine (DMT) and Palmitoylethanolamide (PEA) and novel proprietary combinations of 3,4-Methylenedioxymethamphetamine (MDMA), Ibogaine, Ketamine, and PEA.
  • PEA is the active ingredient of SciSparc’s proprietary CannAmide™.
  • As part of the collaboration agreement between SciSparc and Clearmind, originally announced on March 8,2022, any assets generated from the collaboration shall be jointly owned by SciSparc and Clearmind.

Clearmind Medicine and SciSparc Reflect on Successful Collaboration in 2023 Aiming to Upgrade Wide Range of Psychedelic- Based Treatments

Retrieved on: 
Thursday, January 4, 2024
Psilocybin, Patent, CWY, MDMA, LSD, Lysergic acid diethylamide, IP, PEA, Central nervous system, Patient, Safety, Therapy, DMT, Pharmaceutical industry

Tel Aviv, Israel / Vancouver, Canada, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), (FSE: CWY) (“Clearmind” or “the company"), a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, reflects on the successful collaboration with SciSparc Ltd. (Nasdaq: SPRC) ("SciSparc") in 2023. Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office for unique combinations of future psychedelic-based compounds. The patent applications were filed as part of Clearmind’s ongoing collaboration with SciSparc, a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system.

Key Points: 
  • Tel Aviv, Israel / Vancouver, Canada, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), (FSE: CWY) (“Clearmind” or “the company"), a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, reflects on the successful collaboration with SciSparc Ltd. (Nasdaq: SPRC) ("SciSparc") in 2023.
  • Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office for unique combinations of future psychedelic-based compounds.
  • The patent applications were filed as part of Clearmind’s ongoing collaboration with SciSparc, a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system.
  • As part of the collaboration agreement between Clearmind and SciSparc, originally announced on March 8,2022, any assets generated from the collaboration shall be jointly owned by Clearmind and SciSparc .