PharmAla Biotech Holdings Inc., a Toronto-based biotechnology company, has announced its role as a supplier of MDMA for a clinical trial at Johns Hopkins Medicine. The company's primary focus lies in the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives. CEO Nicholas Kadysh expressed optimism about their continued service to researchers both in the United States and globally, emphasizing that PharmAla's MDMA meets stringent regulatory quality standards set by bodies like the FDA.
PharmAla has developed a new tool available on their website, which allows researchers to access detailed drug product quality information. This tool is designed to aid researchers in swiftly converting their clinical trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing, and Control package. This move underscores PharmAla's commitment to providing rapid and effective support to its research customers.
In addition, PharmAla has announced the termination of its agreement with Red Light Holland, effective September 3, 2024. This strategic decision marks a shift in the company’s focus and partnerships.
On a separate note, PharmAla has been selected to present its novel proprietary molecule, APA-01, at the upcoming European Behavioural Pharmacology Society (EBPS) Workshop. Scheduled for September 26th, the presentation will highlight the development of APA-01, which boasts improved safety pharmacology compared to traditional MDMA. Dr. Harpreet Kaur, Vice President of Research at PharmAla, expressed enthusiasm about the recognition, noting that their work with the Fantegrossi lab continues to be highly regarded by the academic community.
PharmAla Biotech Holdings Inc., listed on the CSE under the ticker MDMA and on the OTCQB under MDXXF, is dedicated to alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials and commercial sales in selected regions. The company also focuses on developing novel drugs within the same class. It distinguishes itself as the sole provider of clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla's research and development division has made significant progress, especially with their lead drug candidate, ALA-002.
PharmAla's approach is built on the principle of maintaining excellent relationships with regulators, which they believe is crucial for success in the psychedelics industry. This regulatory-first philosophy underpins their operations and strategic decisions.
As a biotechnology company, PharmAla aims to bridge the gap between research and practical application, ensuring that high-quality MDMA is available for both clinical trials and treatment purposes. Their innovative approach and commitment to rigorous standards position them as a key player in the field of psychedelic research and development.
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