Cannabis Law Report
AUGUST 18, 2022
The firm’s deep expertise in pharmaceutical sciences, FDA regulatory compliance and pharmaceutical product liability litigation and risk management enables it to address complex legal hurdles faced by stakeholders seeking to research, develop, invest in and bring-to-market psychedelic therapies. BUFFALO, N.Y. , Aug. Tweet this.
Cannabis Law Report
AUGUST 7, 2021
We are currently focused on developing MDMA-assisted therapy as a Breakthrough Therapy for PTSD, with plans to submit for FDA approval in 2023. The results of our successful pivotal Phase 3 clinical trial were recently published in Nature Medicine and profiled on the front page of The New York Times. Key Responsibilities.
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Cannabis Law Report
MAY 31, 2022
Two approaches apply to commercial operations—the traditional medical path and the emerging non-medical state-regulated path, while the other two paths are better seen as non-commercial—underground therapy and religious use. 2022 Active FDA Clinical Trials and State-Regulated Systems. Active FDA Regulated Clinical Trials*.
Cannabis Law Report
NOVEMBER 19, 2021
MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD. MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. Key Responsibilities.
Cannabis Law Report
OCTOBER 2, 2021
We are currently focused on developing MDMA-assisted therapy as a Breakthrough Therapy for PTSD, with plans to submit for FDA approval in 2023. The results of our successful pivotal Phase 3 clinical trial were recently published in Nature Medicine and profiled on the front page of The New York Times.
Cannabis Law Report
MAY 29, 2022
FDA granted Breakthrough Therapy designation for Spravato in 2013 and ultimately approved it for adults who have not responded to treatment after trying other antidepressant medications. More recently, MDMA therapy has inched closer to FDA approval. Clinical Trials and Human Subject Protections.
Cannabis Law Report
JANUARY 12, 2022
The sale will accelerate the development of Gb Sciences’ proprietary Parkinson’s disease and COVID-related Cytokine-Release Syndrome therapies. “We can now concentrate all our energies on advancing our plant-inspired, biopharmaceutical research and development programs into human clinical trials.”
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