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(“IGC”) (NYSE American: IGC) announces today that it has completed Cohort 2 of its Phase 1 clinicaltrial on IGC’s tetrahydrocannabinol (“THC”)-based investigational new drug, IGC-AD1, intended to alleviate the symptoms of individuals suffering from Alzheimer’s disease. This Phase 1 trial is currently testing IGC-AD1 for safety.
Nasdaq:HUGE) (CSE:HUGE) (FRA:0K9) (the “ Company ” or “ FSD ”) announced today that it intends to terminate the Phase 2 clinicaltrial of ultra-micronized palmitoylethanolamide (“PEA”), or FSD-201, for use in treating COVID-19. TORONTO–(BUSINESS WIRE)–FSD Pharma Inc.
There is an urgent need for objective, scientifically sound and robust clinicaltrials to support medicinal cannabis and psychedelics (psilocybin, MDMA, LSD, Ketamine). Extensive early phase experience with appropriate safety oversight and early phase clinic.
Safety Tips and Talking to Your Doctor Always read the label and make sure you’re getting your cannabinoids from a trusted source. It can happen because of injuries, infections, or even things like stress and unhealthy food. Legal and Safety Stuff Don’t forget, laws about cannabinoids are different depending on where you live.
The announcement is riddled with disingenuous doublespeak, starting with the wordy title: “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.” So it’s passing the buck to Congress.
Clinicaltrials into cannabis’ potential as an opioid replacement are well underway in South Africa. Quite frankly, the clinicaltrials couldn’t have come at a better time. About the Opioid Epidemic. This process involves feeding the nutrient-dense aquaculture water to hydroponically cultivated plants.
This includes First Time in Human (“FTiH”) clinicaltrials, which are expected to commence in 2022, for the Group’s lead compound OCT461201, a selective cannabinoid receptor type 2 (“CB2”) agonist with initial indications in the areas of post herpetic neuralgia and visceral pain caused by irritable bowel syndrome.
In quick succession, the Food & Drug Administration (FDA) announced yesterday, December 22 nd , that it issued five warning letters to companies for selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Actions Speak Louder Than Words.
Psilocybin , a psychedelic compound found in a variety of mushrooms, has long been used as a tool to mitigate depression despite the limited amount of research on its efficacy and safety. While 233 participants might sound low, it is still the largest number of humans to participate in a psilocybin-based clinicaltrial.
A 2012 study in rats compared the effects of CBD, CBG, and CBN on food consumption and showed that unlike the others, CBN increased feeding. What can the current clinicaltrials tell us? Regardless of where or what you purchase, it is important to check the laboratory results for potency and safety parameters.
Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. Vigorous scientific research and clinicaltrials are needed.
For their analysis, researchers conducted qualitative interviews with 13 individuals who had participated in a psilocybin clinicaltrial. The 13 individuals were chosen because of their reported improvements in negative drinking behavior following the clinicaltrial. Let us know in the comments!
(IGC) is excited to present preliminary positive secondary end point findings from its Phase 1 clinicaltrial for IGC-AD1. The results of the clinicaltrial have been submitted in the Clinical/Statistical Report (“CSR”) filed with the FDA, and relevant data is also available on Form 8-K filed with the SEC on December 2, 2021.
Under section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act — in what some refer to as the “drug preclusion clause” 4 — any substance that is an active ingredient in an approved drug product, or that is being publicly investigated as such, is excluded from the definition of a legal dietary supplement ingredient. 2021;56:530-543.
Brains is one of a few companies in the world producing CBD as an API for pharmaceutical applications, research, development, and clinicaltrials. The Brains partnership with DSM Venturing will allow the company to take advantage of strategic partnerships that DSM has developed since their initial inception in 1902.
Phase 3 planning for TrustTSC trial ongoing with first patient expected to be enrolled in Q4 2021. Food and Drug Administration (FDA) has granted orphan drug designation to ganaxolone in TSC. Conference call and webcast to be held today at 4:30 p.m. RADNOR, Pa.–(BUSINESS The primary endpoint showed a median 16.6
(NASDAQ: FLGC) (“Flora” or the “Company”), a leading all-outdoor cultivator and manufacturer of global cannabis products and brands, is pleased to announce that it has signed an agreement to begin scientific clinicaltrials globally.
Food and Drug Administration for Generally Recognized as Safe (GRAS) is being pursued. GRAS status will allow for the broad application of this novel ingredient in foods as well as dietary supplements. PCT/CA2021/050886, with a filing date of June 28, 2021. Through the Tetra partnership with Thorne HealthTech, a submission to the U.S.
“The groundbreaking progress that we’ve seen from the Multidisciplinary Association for Psychedelic Studies (MAPS) in its Phase 3 clinicaltrials of MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder (PTSD), including receiving Breakthrough Therapy Designation from the Food and Drug Administration (FDA), shows great promise to date.
Phase IIb clinicaltrial of COMP360 psilocybin therapy for TRD close to completion. Danielle Schlosser PhD appointed Senior Vice-President, Clinical Innovation, to lead therapist research and training, bringing her clinical experience in behavioural health and expertise in digital health innovation. Business highlights.
Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week , “the CBD craze is getting out of hand. The FDA has provided clarity that hulled hemp seed, hemp protein powder, and hemp seed oil can be legally used in foods. CBD is “thriving” in the current regulatory environment, but is it doing so illegally?
In January, the US Food and Drug Administration (FDA) approved the Johnson & Johnson brand nasal spray, Spravato®, as the world’s first and only monotherapy for addressing treatment-resistant cases of major depressive disorder (MDD). What is Ketamine Nasal Spray? What are the negative side effects of ketamine nasal spray for depression?
Following the successful experiment into the potential safety and efficacy of using ketamine for Parkinson’s patients, the university proceeded to sign an exclusive licensing partnership with Pharmather Inc. , As many as 250 clinics across the U.S. ” The Future of Ketamine Use in the Medical Field .
Similar to ketamine, psilocybin has shown great promise in clinicaltrials for helping to effectively treat depression and PTSD (and we’ve written about psilocybin several times on this blog, including here and here ). Food and Drug Administration (FDA) to cities and counties. What are the exact legalities behind ketamine?
We remain encouraged as we continue our evaluations of MYMD-1 for efficacy and safety – especially as studies continue to suggest we may be able to address many of the concerns that are associated with the current drugs on the market today in these disease areas.”. President, Director and Chief Medical Officer of MyMD. “We
One study supporting the efficacy of cannabinoids is in the Journal of Pain and Symptom Management, titled, “Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract in Patients with Intractable Cancer-Related Pain.”
Food and Drug Administration (FDA) when offered in pill form to cancer chemotherapy patients, as well as people who endure appetite loss and/or wasting syndrome caused by AIDS. Additionally, numerous other cannabis-based medications have already gained approval or are in the process of being tested in clinicaltrials.
“These additional patent filings are key as PsyBio moves towards the initiation of appropriately approved safety and efficacy clinicaltrials for our selected compounds within the production and manufacturing arena, for the Company as well as for our investors.”
So just on safety alone, it’s worth using it. We rate levels of evidence, and a high level may be a controlled randomized clinicaltrial (RCT), but there are also observational studies. You can make wonderful foods from them. You really can’t kill people with cannabis. The seeds are very nutritious.
Following the execution of this work, cbdMD Therapeutics will perform the requisite toxicological studies with Ion Tox, a leading in vitro toxicology and ADME-PK testing company, to support the safety of the cannabinoids of interest.
Methods of Consumption Medical marijuana can be consumed in various forms, including smoking or vaporizing dried flowers, consuming edibles or beverages infused with cannabis extracts, or using oils and tinctures that are applied sublingually or added to food. Featured image by Thirdman on Pexels.
Amy Abernethy clarified that CBD products may not be marketed as food or food supplements. According to Abernethy’s testimony, there is no confusion — CBD products that are marketed as food and food supplements are not authorized by the FDA, and violate the federal regulations. “It Kevin McGovern/Shutterstock).
The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinicaltrials and provide for future therapeutic use following anticipated regulatory approvals. in each of the four validation trials with an acceptable yield, which is a noteworthy accomplishment.
Brains is one of a few companies in the world producing CBD as an API for pharmaceutical applications, research, development, and clinicaltrials. The Brains partnership with DSM Venturing will allow the company to take advantage of strategic partnerships that DSM has developed since their initial inception in 1902.
Clinicaltrials across the EU have also shown CBD oils and other hemp products to have a potential range of benefits. The Cannabis Trade Association works to improve and maintain health, safety and environmental regulations and practices around cannabis industries.
Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. Vigorous scientific research and clinicaltrials are needed.
Food and Drug Administration. Additionally, it would open up medical marijuana policies with “directives to conduct research on the impact of marijuana on the brain, the efficacy of medical marijuana, identification of additional medical benefits and uses of cannabis, and support highway safety research.”. Douglas Throckmorton, M.D.
Then, in November 2019, the FDA granted the designation to the nonprofit Usona Institute to study psilocybin’s effect on major depressive order, for which clinicaltrials are currently under way. See Usona Institute, A Study of Psilocybin for Major Depressive Disorder (MDD) , ClinicalTrial ID NCT03866174, available at [link].
Our mushrooms are some of the most tested products on the planet as we cross the lines between Pharmaceutical, Agriculture, Botanical, and Food testing quality assays,” said Optimi Chief Science Officer, Justin Kirkland. The harvest includes the following psilocybin-containing mushroom strains: Koh Samui. Penis Envy. Blue Pulaski.
DUBLIN–(BUSINESS WIRE)–The “Epilepsy – Pipeline Insight, 2021” clinicaltrials has been added to ResearchAndMarkets.com’s offering. It covers the pipeline drug profiles, including clinical and nonclinical stage products. For more information about this clinicaltrials report visit [link].
While anecdotal evidence and individual success stories have sparked interest in using MMJ for seizure control, scientific research plays a crucial role in establishing its safety and efficacy. Clinicaltrials and studies are underway to examine the potential benefits and risks of MMJ as a treatment option for epilepsy.
Food and Drug Administration (FDA) retains its authority to regulate ingestible and topical products, including those that contain hemp and hemp extracts such as CBD. Further, the primary motivation for the Warning Letters issued in 2015, 2016, and 2017 concerned the improper use of disease-remediation claims by supplement/food companies.
This “zero recall” standard, the team said, was attributed to the fact that their cannabis product standards with regard to foodsafety and health was high and involved documentation of over 100 pages. . These are the responsibility of the manufacturer. Setting Standards for Cannabis Research Studies .
Charles River Laboratories, a renowned CRO engaged by Virpax to perform Food and Drug Administration (FDA) required pre-clinical studies, has completed a single dose pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application (“IND”) enabling trials.
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