Special access program

Cortexa Leads the World in First Supply of Psilocybin Under the TGA’s Authorized Prescriber Scheme

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月曜日, 3月 18, 2024

Psilocybin, Depression, Patient, Research, MDXX, Sale, BHC, Ahmad Adaya, Prescription, GMP, Clinical trial, OTC, Authorization, MDMA, Special access program, Pharmaceutical industry

Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.

Key Points:

Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.
The patient was being treated with Psilocybin for treatment resistant depression.
In doing so, Cortexa is now established as the only Australian company able to immediately supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s Authorised Prescriber Scheme.
Cortexa has created a national network of relationships with research institutes, key opinion leaders and emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.

Accenture Federal Services Partners with Microsoft to Launch Cloud Modernization and Migration Factory on Azure

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水曜日, 3月 27, 2024

Accenture Federal Services is partnering with Microsoft to launch a first-of-its-kind, end-to-end, Cloud Modernization and Migration Factory on Microsoft Azure Government to meet the stringent security standards required for those operating across the national security space, including the Special Access Program community.

Key Points:

Accenture Federal Services is partnering with Microsoft to launch a first-of-its-kind, end-to-end, Cloud Modernization and Migration Factory on Microsoft Azure Government to meet the stringent security standards required for those operating across the national security space, including the Special Access Program community.
“We’re thrilled to have Accenture Federal Services serve as a key federal systems integrator partner for Microsoft’s classified clouds.
Staffed by cleared cloud engineers, architects, and data scientists, all steeped in DevSecOps, the Cloud Modernization and Migration Factory features an operationalized, SECRET factory floor, purpose-fit for securely migrating on premise workloads into the cloud in compliance with federal guidelines.
Accenture Federal Services and Microsoft will also jointly build and use migration tools harnessing the power of Generative AI to accelerate modernization.

ATMA CENA Psychedelic Healthcare Solutions Opens Psychedelic-Assisted Therapy Clinic in Calgary and Provides Update of its Clinic Network

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木曜日, 3月 14, 2024

CALGARY, AB, March 14, 2024 /PRNewswire/ - ATMA CENA Psychedelic Healthcare Solutions (PHS) is a collaboration of ATMA Journey Centers Inc. ("ATMA"), Cena Life Inc ., and partners across Canada to advance and expand access to psychedelic-assisted therapy (PaT) through the establishment of a clinic network.

Key Points:

CALGARY, AB, March 14, 2024 /PRNewswire/ - ATMA CENA Psychedelic Healthcare Solutions (PHS) is a collaboration of ATMA Journey Centers Inc. ("ATMA"), Cena Life Inc ., and partners across Canada to advance and expand access to psychedelic-assisted therapy (PaT) through the establishment of a clinic network.
ATMA CENA PHS is pleased to announce commencement of the Calgary Clinic operations and its new location in Edmonton.
ATMA CENA Psychedelic Therapy Edmonton – 5555 Calgary Trail NW, Edmonton, AB
ATMA CENA Psychedelic Therapy Calgary – 742 – 42nd Ave SE, Calgary, AB
ATMA CENA Psychedelic Therapy Toronto – Woodbridge, Vaughan
Utilizing Alberta's Psychedelic Drug Treatment Service Standards and the College of Physicians and Surgeons of Alberta Accreditation Program as foundational principles, ATMA CENA clinics will aim to support the establishment of the necessary infrastructure that enables standardized care.
In the delivery of PaT across Canada, ATMA CENA PHS aims to support care that is safe, operationally consistent, efficient, effective, and regulation compliant.

PharmAla and Red Light Holland to Collaborate on Medical Psilocybin Development

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金曜日, 2月 9, 2024

VANCOUVER, British Columbia, Feb. 09, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”) (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 that it has entered into a consulting relationship with Red Light Holland Corp. (“Red Light”), (CSE: TRIP) to consult on the development of clinical-grade Psilocybin Drug Product extracted from Red Light Holland’s mushroom portfolio.

Key Points:

VANCOUVER, British Columbia, Feb. 09, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”) (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 that it has entered into a consulting relationship with Red Light Holland Corp. (“Red Light”), (CSE: TRIP) to consult on the development of clinical-grade Psilocybin Drug Product extracted from Red Light Holland’s mushroom portfolio.
“As we have seen in the past number of months, the market for Psychedelic drug products is rapidly evolving.
PharmAla will also help Red Light with Regulatory Support and we are confident their knowledge, expertise and leadership, will help increase the efficiency of Red Light Holland in achieving our goal of supplying our psilocybin capsules to those in need, and creating positive change.”
Under the terms of the contract, PharmAla’s manufacturing experts have been retained by Red Light to consult and provide their expertise to Red Light in an all-cash consulting contract for one year, with the goal of developing GMP and regulatory documentation of Red Light’s Psilocybin capsule products.
The agreement also includes the provision that, upon completion of the Drug Product to specification, PharmAla and Red Light may enter into a sales agreement, where PharmAla would sell the products or provide them to its affiliates in global markets as Red Light’s exclusive sales agent.

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

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木曜日, 1月 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.

MaaT Pharma to Host Virtual KOL Event on MaaT013 and MaaT033 Following ASH 2023 Presentations

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火曜日, 12月 12, 2023

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Key Points:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, announced that it will host a virtual KOL (Key Opinion Leader) event on data presented during the 2023 ASH annual meeting including efficacy and safety results for its lead drug candidate, MaaT013, currently in development for acute Graft-versus-Host Disease (aGvHD) and details on MaaT033, developed as an adjuvant therapy to improve patients’ survival following allogeneic hematopoietic stem cell transplantation (allo-HSCT), on Monday, December 18, 2023, at 6:00 pm CET (12:00 pm EST).
The event will feature presentations from the Company’s CEO and co-founder, Hervé Affagard as well as the following KOLs:
Mohamad Mohty, M.D., Ph.D., Professor of Hematology at Sorbonne University, and head of the Clinical Hematology and Cellular Therapy Department at Saint-Antoine Hospital, Paris, France will comment on the positive data on MaaT013 presented for the Early Access Program; and
Florent Malard, M.D., Ph.D., Professor of Hematology at the Saint-Antoine Hospital and Sorbonne University, Principal investigator of Phase 2b trial evaluating MaaT033 in patients receiving allo-HSCT, will provide detailed information on the ongoing trial.
Registration & link to access the event: https://app.livestorm.co/newcap-1/maat-pharma-presentation?type=detailed
A replay will be made available on the Company’s website for at least 90 days.

MaaT Pharma Presents Positive Results with Lead Product MaaT013 and Provides Insights on Ongoing Phase 2b Trial with MaaT033 at ASH 2023

Retrieved on:

月曜日, 12月 11, 2023

“It reinforces our approach based on restoring patients’ immune systems through gut microbiome ecosystem therapies.

Key Points:

“It reinforces our approach based on restoring patients’ immune systems through gut microbiome ecosystem therapies.
OS was 56% at 6 months and 47% at 12 months with a median follow up of 355 days.
A Phase 3 trial is currently ongoing in Europe to confirm these results in ruxolitinib-refractory patients ( NCT04769895 ) with ORR expected in mid-2024.
MaaT Pharma also presented its ongoing Phase 2b trial design for MaaT033, its second candidate, at the 2023 ASH Annual Meeting.

ATMA and Cena Life Launch Nationwide Psychedelic-Assisted Therapy Healthcare Network

Retrieved on:

木曜日, 12月 7, 2023

CALGARY, AB, Dec. 7, 2023 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA") and Cena Life , forefront leaders in advancing psychedelic-assisted therapy (PaT) are pleased to announce the opening of a licensed Calgary Clinic and the establishment of the Psychedelic-Assisted Therapy Healthcare Network, a national clinical network for the emerging psychedelic-assisted therapy sector.

Key Points:

CALGARY, AB, Dec. 7, 2023 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA") and Cena Life , forefront leaders in advancing psychedelic-assisted therapy (PaT) are pleased to announce the opening of a licensed Calgary Clinic and the establishment of the Psychedelic-Assisted Therapy Healthcare Network, a national clinical network for the emerging psychedelic-assisted therapy sector.
Like the evolving services in the Cena Life practice in Edmonton, the Calgary clinic will offer KaT, rTMS, SAP application support as well as regular psychological counselling services.
Together, we aim to create a network that prioritizes patient well-being while fostering a collaborative and supportive environment for practitioners.
Practitioners wishing to join The Psychedelic Healthcare Network are encouraged to take the required training for PaT in advance of practice.

World’s First Observational Trial to Assess Real-World Efficacy of MDMA Treatment

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木曜日, 11月 9, 2023

The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.

Key Points:

The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.
This trial will generate Real World Evidence (“RWE”) on the efficacy of MDMA in the treatment of Post-Traumatic Stress Disorder which may be submitted to Health regulators, including Health Canada and Veterans Affairs Canada.
As the trial is Observational in nature, no patients will be dosed as part of the trial’s protocol.
The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program.

Biological Dynamics Announces Early Access Program to Its ExoVerita™ Pro Platform

Retrieved on:

水曜日, 11月 8, 2023

Biological Dynamics, Inc. , the leader in exosome-isolation technology, today announced the first opportunity for external users to access the company’s ExoVerita Pro, a cost-efficient, automated exosomal enrichment platform that delivers samples with best-in-class yields, purity, and reproducibility.

Key Points:

Biological Dynamics, Inc. , the leader in exosome-isolation technology, today announced the first opportunity for external users to access the company’s ExoVerita Pro, a cost-efficient, automated exosomal enrichment platform that delivers samples with best-in-class yields, purity, and reproducibility.
“Technology is revolutionizing our understanding and management of some of our most challenging diseases,” said Paul R. Billings, M.D., Ph.D., CEO and Director of Biological Dynamics.
Biological Dynamics’ ExoVerita technology platform offers an automated workflow for successfully detecting and recovering exosomes that have benefits over other methods, such as ultracentrifugation and column purification.
Biological Dynamics will showcase its Early Access Program and products at the Association for Molecular Pathology (AMP) Annual Meeting in Salt Lake City, Utah, Nov. 14-18, and will debut ExoVerita Pro at the SelectBio Conference in Laguna Hills, Calif., Nov. 28-30.