Cannabis Law Report

NOVEMBER 19, 2021

“These additional patent filings are key as PsyBio moves towards the initiation of appropriately approved safety and efficacy clinical trials for our selected compounds within the production and manufacturing arena, for the Company as well as for our investors.” ” About PsyBio Therapeutics Corp.

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Cannabis Law Report

AUGUST 17, 2021

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. The condition is caused by inherited mutations in either the TSC1 gene or the TSC2 gene. RADNOR, Pa.–(BUSINESS

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Pharmaceutical Clinical Trials Treatment Patients 98

The Cannigma

MARCH 7, 2022

CBN’s ability to target CB2 receptors, in comparison to THC (which prefers the CB1 receptor), gives it better credibility in treating autoimmune conditions such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. What can the current clinical trials tell us?

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THC Sleep Clinical Trials Cannabinoids 140

Cannabis Law Report

APRIL 21, 2022

The availability of larger quantities of cGMP-compliant MDMA will facilitate ongoing clinical trials 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.

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Clinical Trials Research and Development Therapy Media 52

Cannabis Law Report

AUGUST 3, 2021

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 clinical trials are needed.

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Clinical Trials Events Treatment Banking 105

Canna Care Docs

OCTOBER 3, 2023

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.”

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Cannabis Law Report

OCTOBER 13, 2021

Continued innovation, as demonstrated by our expanding IP portfolio, positions Cybin as a leading innovator in the development of putative psychedelic treatments for a variety of mental health conditions,” said Doug Drysdale, the company’s CEO. Vigorous scientific research and clinical trials are needed. About Cybin.

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Clinical Trials Research and Development Treatment Conditions 52

Cannabis Law Report

JULY 29, 2021

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.

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Research and Development Clinical Trials Events Cannabinoids 105

MMJ Recs

NOVEMBER 30, 2023

Medical marijuana has shown potential in treating a wide range of medical conditions, including epilepsy. Epilepsy and MMJ: A Patient’s Perspective For individuals living with epilepsy, finding an effective treatment is often a journey marked by trial and error.

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Cannabis Law Report

OCTOBER 9, 2021

A coalition of Pennsylvania lawmakers introduced a bill this week that’s meant to promote research into the therapeutic potential of psilocybin mushrooms for mental health conditions such as post-traumatic stress disorder (PTSD)—the latest example of how the psychedelics reform movement is gaining momentum. Led by Rep.

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Therapy Clinical Trials Treatment Legislation 52

Cannabis Law Report

JULY 7, 2021

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

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Pharmaceutical Data Clinical Trials Research and Development 105

Veriheal

APRIL 11, 2022

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 clinical trials.

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Pharmaceutical Research and Development DEA Clinical Trials 104

Cannabis Law Report

FEBRUARY 9, 2022

There’s also concern about a rare condition known as wood lover’s paralysis , a condition that produces muscle weakness a few hours after hallucinogenic mushrooms are consumed. Scientists don’t know why this condition occurs, but it isn’t believed to happen with Psilocybe cubensis. Other species might be introduced later.

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Clinical Trials Microdosing Safety Conditions 52

Cannabis Law Report

NOVEMBER 9, 2021

As an institution dedicated to diagnosing and treating serious blood diseases and with the ability to pursue investigational medicines from development to manufacture and clinical trial for patients who have exhausted all approved treatment options, having a cost-effective and rapid production chain is integral to ÚHKT’s mission.

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Clinical Trials Research and Development Therapy Supply Chain 52

Cannabis Law Report

NOVEMBER 16, 2021

(Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced today that it has received U.S. The secondary measures will be the safety, tolerability, and pharmacokinetics in this population of patients. Chapman continued.

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Pharmaceutical Clinical Trials Research and Development Therapy 52

Cannabis Law Report

JULY 4, 2021

Clinical trials 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. With CBD, though, the “high” feeling is not created.

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The Cannigma

JUNE 15, 2021

More and more CBD products on the market promise relief from pain, depression, anxiety, neurodegenerative conditions, and a plethora of other symptoms and conditions. Amy Abernethy clarified that CBD products may not be marketed as food or food supplements. Easy access. But that doesn’t make it completely risk free.

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SpeedWeed

MARCH 18, 2021

Given the topical nature of the current trial and its relevance for public policy on medical cannabis, participants might have been biased to report positive effects regardless of condition. for the production of cannabis used in federally-regulated clinical trials.

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Clinical Trials THC Strains Cannabis 40

Cannabis Law Report

JUNE 7, 2021

Food and Drug Administration (U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the U.S.

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Clinical Trials Research and Development Therapy Supply Chain 64

Cannabis Law Report

MAY 29, 2022

Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the therapeutic effects of psychedelic drugs. [1] Clinical Trials and Human Subject Protections. Zachary Fuchs.

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Research and Development DEA Clinical Trials Therapy 52

Cannabis Law Report

JULY 9, 2021

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 clinical trials are currently under way. See Usona Institute, A Study of Psilocybin for Major Depressive Disorder (MDD) , Clinical Trial ID NCT03866174, available at [link].

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Law Therapy Clinical Trials Research and Development 105

Cannabis Law Report

JANUARY 11, 2019

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.

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Hemp CBD Law Seed-To-Sale 49

The Joint Blog

JULY 25, 2020

organic food market by 2025 is at $70.4 FDA is the government agency that ensures the safety and quality of foods, drugs, cosmetics, and other like products marketed in the United States. CBD Legal and Safety Issues An FDA report presented to the U.S. It has been predicted that the U.S CBD Products and the FDA The U.S.

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CBD Clinical Trials Safety Media 33

Cannabis Law Report

JULY 24, 2019

Food and Drug Administration sent a warning letter to the company for selling CBD-based products that claim to treat serious diseases. can be used to help manage a wide range of health conditions, such as. Mental conditions like anxiety, depression, and PTSD.”. Full report at. Full Letter. Source: [link]. July 22, 2019.

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CBD Tincture Pets Chronic Pain 51

Cannabis Law Report

SEPTEMBER 24, 2019

Epidyolex has been approved as a treatment option for children as young as two with Lennox-Gastaut syndrome or Dravet syndrome – difficult-to-treat conditions that can cause multiple seizures a day. The medication, developed by GW Pharmaceuticals, will be used in combination with another epilepsy medication called clobazam.

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Pharmaceutical Epilepsy Research and Development Medicine 55

SpeedWeed

AUGUST 3, 2021

Food and Drug Administration (FDA). If it went through the normal process of being tested for toxicology in animals, and then went through the usual processes of studying it in humans in clinical trials, it might have an application. This is a serious condition. Photo courtesy of Ethan Russo Dr. Ethan Russo, M.D.

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THC Vaping Blood Pressure Hemp 58

SpeedWeed

AUGUST 5, 2021

Food and Drug Administration (FDA). If it went through the normal process of being tested for toxicology in animals, and then went through the usual processes of studying it in humans in clinical trials, it might have an application. This is a serious condition. Photo courtesy of Ethan Russo Dr. Ethan Russo, M.D.

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THC Vaping Cannabinoids Blood Pressure 52

SpeedWeed

AUGUST 4, 2021

Food and Drug Administration (FDA). If it went through the normal process of being tested for toxicology in animals, and then went through the usual processes of studying it in humans in clinical trials, it might have an application. This is a serious condition. Photo courtesy of Ethan Russo Dr. Ethan Russo, M.D.

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THC Marijuana Vaping Blood Pressure 52

SpeedWeed

AUGUST 4, 2021

Food and Drug Administration (FDA). If it went through the normal process of being tested for toxicology in animals, and then went through the usual processes of studying it in humans in clinical trials, it might have an application. This is a serious condition. Photo courtesy of Ethan Russo Dr. Ethan Russo, M.D.

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THC Vaping Blood Pressure Hemp 52

Project CBD

FEBRUARY 28, 2023

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.

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CBD Seed-To-Sale Food Access 144

SpeedWeed

AUGUST 4, 2021

Food and Drug Administration (FDA). If it went through the normal process of being tested for toxicology in animals, and then went through the usual processes of studying it in humans in clinical trials, it might have an application. This is a serious condition. Photo courtesy of Ethan Russo Dr. Ethan Russo, M.D.

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THC Vaping Blood Pressure Hemp 52

Veriheal

JUNE 29, 2022

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 clinical trial.

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Clinical Trials Blood Pressure Treatment Therapy 103

Canna Law Blog

NOVEMBER 6, 2021

To acknowledge its impressive safety record and potential for treating depression more effectively than existing therapies, the Food and Drug Administration designated psilocybin a breakthrough therapy in 2018 and 2019 for treating drug-resistant depression and major depressive disorder.

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Clinical Trials DEA Research and Development Therapy 98

Cannabis Law Report

OCTOBER 26, 2019

The TG Act also applies to foods, cosmetics, chemicals and general consumer products in respect of which therapeutic claims are made. One such circumstance is a clinical trial. A clinical trial in Australia must have an Australian sponsor (whether it be an individual (e.g.,

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Clinical Trials Medicine Research and Development Compliance 45

CannaMD

MARCH 8, 2021

Food & Drug Association’s role in H.B. Authorizing the department to sample marijuana delivery devices from a dispensing facility to determine safety [p. What is Florida House Bill 1455? Florida H.B. 1, line 14]. 1, line 17]. 1, line 19]. 1, line 24]. 1455: Other THC Issues.

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Canna Law Blog

MARCH 4, 2020

Similar to ketamine, psilocybin has shown great promise in clinical trials 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.

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Therapy Legalization Chronic Pain DEA 90

Cannabis Law Report

SEPTEMBER 22, 2021

Food and Drug Administration. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S.

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