Cannabis Law Report

NOVEMBER 17, 2022

The Finnish Medicines Agency (Fimea) has granted Clairvoyant Therapeutics, a Canadian drug company, permission to study the effects of psychedelic drug therapies for the treatment of alcohol addiction. Fimea’s approval marks the first time psychedelic drug trials will be carried out in Finland.

Therapy 52

Therapy Clinical Trials Treatment Medicine 52

Puff Puff Post

MARCH 10, 2020

INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. About INM-755: INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases.

Clinical Trials 84

Clinical Trials Pharmaceutical Research and Development Cannabinoids 84

Canna Law Blog

NOVEMBER 10, 2020

I was talking to another lawyer about last week’s vote by Oregonians to legalize psilocybin therapy here in the state. Public Law 115-176 (“Right to Try”) is a federal law enacted in 2018 that creates a uniform system for terminal patients seeking access to investigational treatments.

Therapy 78

Therapy Clinical Trials Decriminalization Patients 78

Cannabis Law Report

MARCH 18, 2022

Husch Blackwell has launched its Psychedelics and Emerging Therapie s team, an interdisciplinary, cross-office group of lawyers capable of addressing the challenges faced by innovators that seek to research, develop and commercialize novel therapies based on psychedelic drugs. Steve Levine.

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Therapy Research and Development Clinical Trials Environment 52

Cannabis Law Report

JULY 13, 2022

Their position as therapeutic practitioners, as well as their work in conducting the kind of clinical trials necessary to advance regulatory outcomes for psychedelic medicines, make them ideal partners in alignment with Optimi’s strategic goals.”. VANCOUVER, British Columbia, July 13, 2022 (GLOBE NEWSWIRE) — Optimi Health Corp. (

Therapy 52

Therapy Clinical Trials Microdosing Research and Development 52

Cannabis Law Report

MAY 19, 2022

This is Numinus’ first psilocybin-assisted therapy treatment outside of ongoing clinical trials, and among the first to use of this regulatory mechanism through Health Canada’s Special Access Program (“SAP”), which was amended January 5 th , 2022 to include access to psychedelic compounds on a case-by-case basis.

Therapy 52

Therapy Treatment Clinical Trials Access 52

Cannabis Law Report

FEBRUARY 24, 2022

Canada recently amended its Controlled Drugs and Substances Act (CDSA) to allow for psilocybin and MDMA therapy in limited circumstances. Each request is decided on a patient-by-patient basis and approval is usually only given to drugs with successful phase II or phase II clinical trials. Subsection 56(1) Exemption. Conclusion.

Therapy 52

Therapy Access Clinical Trials Treatment 52

Cannabis Law Report

DECEMBER 14, 2021

IGC” or the “Company”) today announced positive primary endpoint data for its Phase 1 clinical trial for IGC-AD1, which is a proprietary cannabinoid-based investigational new drug candidate for patients who have Alzheimer’s disease. The primary endpoint of our Phase 1 clinical trial was to test and demonstrate safety and tolerability.

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Clinical Trials Safety Data Patients 52

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.

Therapy 52

Therapy Research and Development Pharmaceutical Treatment 52

Veriheal

JUNE 7, 2021

Always consult a physician before attempting alternative therapies. However, Molly that has been seized by law enforcement has been found to contain other types of drugs too, some also contained no MDMA at all despite supposedly being the crystalline form of MDMA. . Conditions That Could Benefit from MDMA Therapy .

Therapy 85

Therapy Treatment Conditions Clinical Trials 85

Cannabis Law Report

JULY 9, 2021

The state of the law on psychedelic substances is in flux. The use of psychedelic substances to treat mental illness and physical disorders is known as “psychedelic therapy.” Psychedelic therapy is not a fringe phenomenon. Some of the most promising substances, and the law applicable to each, are outlined below: Psilocybin.

Law 105

Law Therapy Clinical Trials Research and Development 105

Cannabis Law Report

DECEMBER 2, 2021

(IGC) is excited to present preliminary positive secondary end point findings from its Phase 1 clinical trial for IGC-AD1. The results of the clinical trial 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.

Clinical Trials 52

Clinical Trials Data Patients THC 52

Cannabis Law Report

MARCH 7, 2023

Incannex Healthcare Limited, a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for unmet medical needs, announced that it has engaged Catalent (Catalent) to develop and manufacture a cGMP-grade psilocybin drug product for: (1) use in Incannex’s proprietary psilocybin-assisted psychotherapy (..)

Clinical Trials 52

Clinical Trials Therapy Pharmaceutical Medicine 52

Cannabis Law Report

SEPTEMBER 13, 2021

(Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced that it intends to initiate dosing for a Phase 2 trial of MYMD-1’s function in delaying aging early in the fourth quarter of 2021. in the blood. No approved TNF inhibitor has ever been dosed orally.

Clinical Trials 52

Clinical Trials Pharmaceutical Research and Development Therapy 52

Puff Puff Post

MARCH 10, 2020

INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. About INM-755: INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases.

Clinical Trials 40

Clinical Trials Pharmaceutical Research and Development Cannabinoids 40

Cannabis Law Report

MAY 19, 2022

Before January, people could only access psychedelic-assisted psychotherapy through clinical trials or medical exemptions. In April, a clinic called Roots To Thrive, in Nanaimo, B.C., became the first health centre in Canada to offer a legal psilocybin group therapy program, in which Hartle took part.

Therapy 52

Therapy Patients Treatment Clinical Trials 52

Cannabis Law Report

JULY 1, 2021

The Project on Psychedelics Law and Regulation (POPLAR). The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is engaged in a three-year initiative to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics. Background. The Project.

Law 59

Law Policy Research and Development Clinical Trials 59

Cannabis Law Report

MAY 6, 2021

EMDMA-001 has been modelled on a major Phase III clinical trial developed by the Multidisciplinary Association for Psychedelic Studies (MAPS).… … Read More.

Clinical Trials 59

Clinical Trials Therapy Programs Medicine 59

SpeedWeed

JULY 6, 2021

Harvard Law School is planning to open the first US policy center focused on the legalization and regulation of psychedelics like psilocybin, MDMA, and LSD. . Professor of Law at Harvard Law School. “By Harvard’s new center will be the first to focus solely on psychedelics policy and laws rather than research, though.

Policy 52

Policy Law Research and Development Therapy 52

Cannabis Law Report

NOVEMBER 23, 2021

Psychedelic patents should be limited, according to Harvard Law School experts, who are also warning patent reform is necessary for the psychedelics sector to reach its full potential in addressing the global mental health crisis. Harvard Law Review Forum, Vol. Harvard Law School. 135, 2022 (Forthcoming). Mason Marks.

Law 52

Law Research and Development Therapy Clinical Trials 52

Cannabis Law Report

AUGUST 10, 2022

According to CAMH’s lead investigator, clinical trials suggest that psilocybin, combined with psychotherapy, can produce “ sustained antidepressant effects” in individuals living with severe depression.

Clinical Trials 52

Clinical Trials Research and Development Therapy Microdosing 52

Veriheal

MARCH 20, 2023

Alternative medicine is becoming more widely acknowledged and practiced than ever before, opening the door for therapies like psychedelics to enter the world of mainstream healthcare. Psilocybin therapy is both studied and used by highly legitimate medical establishments. Ned Lamont signed a bill (HB 5506) to fund psychedelic therapy.

Clinical Trials 98

Clinical Trials Therapy Decriminalization Treatment 98

Cannabis Law Report

NOVEMBER 1, 2021

Harvard Law School; Yale Law School; University of New Hampshire Franklin Pierce School of Law; Leiden Law School, Center for Law and Digital Technologies. Harvard Law School. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics.

Research and Development 52

Research and Development Law Clinical Trials Therapy 52

Cannabis Law Report

DECEMBER 5, 2021

Revenue share payments will be based on North America sales of MDMA for use in MDMA-assisted therapy, will terminate after 8 years, and include a reciprocity payment structure that reduces payments once certain financial milestones are met. The safety and efficacy of MDMA-assisted therapy is currently under investigation.

Therapy 52

Therapy Access Research and Development Clinical Trials 52

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. There are also illicit sales of psychedelic drugs separate from any therapeutic or ceremonial use.

Clinical Trials 52

Clinical Trials Legalization Therapy Decriminalization 52

Cannabis Law Report

JULY 15, 2021

Halucenex to progress phase II clinical trial to test the efficacy of psilocybin when used to treat Post Traumatic Stress Disorder (PTSD). ? Halucenex’s operation progress continues – USP 61 test protocols complete providing additional validation of psilocybin compounds ahead of Clinical Trial Application. ? 02395733.

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Clinical Trials Therapy Treatment Access 96

Cannabis Law Report

FEBRUARY 28, 2022

Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. 11 × 11. In 2017, the FDA designated MDMA a breakthrough therapy for PTSD.

Research and Development 52

Research and Development Therapy Law Clinical Trials 52

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.

Clinical Trials 105

Clinical Trials Research and Development Compliance Compliance 105

Cannabis Law Report

AUGUST 12, 2021

Highlights: Phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression (TRD) close to completion; on track to report data by end of 2021. This is the largest trial ever conducted in psilocybin therapy, and it was done amid the lockdowns and challenges of the COVID pandemic. million, or $0.79

Clinical Trials 98

Clinical Trials Therapy Research and Development Data 98

NewsMunchies

NOVEMBER 12, 2021

In clinical trials, psilocybin (the psychoactive substance in mushrooms) has shown tremendous promise in treating severe depression, post-traumatic stress disorder, and other mental illnesses. The War on Drugs is a failure and continuing to focus law enforcement resources on people using cannabis and psilocybin doesn’t make sense.

Clinical Trials 90

Clinical Trials Therapy Decriminalization DEA 90

Cannabis Law Report

SEPTEMBER 10, 2021

Nick Milne PhD, Co-founder and CSO of Octarine said: “Our core ambition at Octarine is to advance psychedelic therapy across Europe and the world in a way that is consistent with sustainability principles while ensuring patient accessibility.

Research and Development 104

Research and Development Clinical Trials Therapy Environment 104

Cannabis Law Report

MAY 28, 2022

Husch Blackwell is the the first Am Law 100 firm to offer counsel for companies in the emerging psychedelic industry. Natasha Sumner, Kimberly Chew and Karen Luong are attorneys in Husch Blackwell LLP’s virtual office, The Link, and lead the firm’s Psychedelics & Emerging Therapies practice. Here’s the introduction.

Research and Development 52

Research and Development Therapy Clinical Trials Legalization 52

Cannabis Law Report

JULY 28, 2021

The Company and Its Subsidiary KGK Science Have Also Completed the Pre-Qualification Audits of Its Canadian Facilities to Enable Clinical Trials in an Arrangement with Aleafia Health. The audits will enable KGK to conduct clinical trials in the areas of psychedelics and nutraceuticals, among other substances of study.

Clinical Trials 81

Clinical Trials Research and Development Treatment Therapy 81

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. MEDIA CONTACT .

Clinical Trials 52

Clinical Trials Research and Development Therapy Media 52

Cannabis Law Report

OCTOBER 19, 2021

Unlike other therapies, MYMD-1 has been shown to selectively block TNF-? In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. a driver of chronic inflammation. No approved TNF inhibitor has ever been dosed orally.

Pharmaceutical 52

Pharmaceutical Therapy Clinical Trials Chronic Pain 52

Cannabis Law Report

JUNE 24, 2022

The leader of the New Jersey Senate filed a bill on Thursday that would legalize the possession, home cultivation and gifting of psilocybin mushrooms for adults 21 and older—with provisions that give adults even more freedoms for the psychedelic than are afforded under the state’s current marijuana laws. Full story at.

Clinical Trials 52

Clinical Trials Legalization Research and Development Therapy 52

Cannabis Law Report

APRIL 27, 2022

MDMA-assisted therapy has already shown incredible results in the stage three clinical trials for individuals suffering from severe PTSD,” Ginal told committee members. “I The bipartisan and bicameral legislation is being sponsored by Reps. Patrick Neville (R) and David Ortiz (D), along with Sens.

Clinical Trials 52

Clinical Trials Legalization Therapy Food 52