On this second point, Kennedy elsewhere contradicts his own assertion that user fees lead reviewers to feel beholden to sponsors. Kennedy has stated that FDA’s recent denial of the psychedelic drug MDMA to treat PTSD constitutes “aggressive suppression of psychedelics” and has listed it as among...
"Although psychedelics have potential in mental health care, FDA approval of new drugs should always be based on rigorous evidence of safety and efficacy." "By rejecting the approval of MDMA, the FDA will encourage this company and other researchers of psychedelic drugs to conduct more rigorous ...
Psychedelics CHICAGO and TORONTO, Jan. 11, 2022 (GLOBE NEWSWIRE) —Wesana Health Holdings Inc.(“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pl...
3. A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis. ClincialTrials.gov identification: NCT04951622. Updated August 14, 2024. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT04951622 4. Antozzi C, Guptill J, Bril V, et al. Safety and Ef...
Also, MDMA has a direct effect on the amygdala that other psychedelics don’t seem to have. MDMA affects the part of the brain that’s mostly responsible for fear, the flight or fight response. With people who have PTSD, their amygdala is hyperactive. MDMA directly reduces that;...
In a 10 to 1 vote, the FDA advisory panel on MDMA therapy for PTSD decided that the benefits of the treatment do not outweigh the risks.
so the market may have already priced in the downside. arguments that the negative fda decision on mdma may actually be good news for compass pathways plc and peers are not persuasive. the fda decision is not the end of the road for the psychedelics sector, but compass pathways ...
Pharmacy Focus: World Psychedelics Day Ashley Gallagher, Associate Editor November 1st 2024 Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years Ashley Gallagher, Associate Editor June 7th 2024 Pharmacy Focus: The Role of Pharmacists in Promoting Mental Health Care...
Psychedelics Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (“Algernon”), a clinical stage pharmaceutical development company, is pleased to announce that it has filed a pre-IND (Investigational New Drug) meeting request with ...
the success of the companies’ research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the reg...