FDA
Proposed Menthol Ban Could Leave 22nd Century’s VLN® Menthol King as the Only Menthol Cigarette in the $26 Billion U.S. Menthol Market FDA to Advance Reduced Nicotine Content Standards for All Combustible Cigarettes in Q4 2023 Paradigm Shift in Tobacco Health Policy and Regulation Expected to Generate Major Gains for Public Health Buffalo, New York–(Newsfile […]
Committed to Supporting New Zealand’s Reduced Nicotine Law with Its Tobacco Biotechnology New Law Represents Significant Opportunity to Improve National Health through Well Designed Public Policy Framework Believes New Zealand Law Provides a Template for Similar Action in Other Countries, Including the United States Buffalo, New York–(Newsfile Corp. – December 13, 2022) – 22nd […]
Reduced nicotine cigarettes increase cessation, decrease consumption, decrease dependence, and reduce toxicants Study dispels common misconception that reduced nicotine cigarettes worsen general health and mental health problems BUFFALO, N.Y., Nov. 07, 2022 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, […]
POTOMAC, Md., December 02, 2021–(BUSINESS WIRE)–(NYSE American: IGC), India Globalization Capital, Inc. (IGC) is excited to present preliminary positive secondary end point findings from its Phase 1 clinical trial for IGC-AD1. The investigational new drug, IGC-AD1, is IGC’s proprietary Tetrahydrocannabinol (THC)-based candidate designed to treat certain symptoms of Alzheimer’s disease. The results of the clinical […]
Entheon Biomedical Provides Update on Clinical and Preclinical DMT Programs
Shipment of GMP DMT, In Vitro HERG and Genotox Assays Completed, and In Vivo Toxicity Assays Underway Vancouver, British Columbia–(November 24, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company”), a biotechnology company focused on developing psychedelic medicines to treat addiction, is pleased to provide an update on […]
Tryp Therapeutics Announces Phase 2a Clinical Trial for Fibromyalgia with the University of Michigan
The study is expected to be the world’s first Phase 2a clinical trial evaluating the efficacy of psilocybin and psychotherapy to treat fibromyalgia San Diego, California–(Newsfile Corp. – July 21, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp”), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs through accelerated regulatory […]
PharmaTher Announces FDA Approval of Ketamine IND In The Treatment of Parkinson’s Disease
TORONTO, May 17, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Investigational New Drug (“IND”) application to proceed with a Phase 2 clinical trial to evaluate the safety, […]
Revive Therapeutics Files for FDA Orphan Drug Designation for Psilocybin in Traumatic Brain Injury
TORONTO, April 27, 2021 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration (“FDA”) to […]
TORONTO, April 27, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (“PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, today announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office outlining the novel use of ketamine as a potential treatment for Type 2 diabetes and obesity, based on […]
OXFORD, Ohio and COCONUT CREEK, Fla., April 26, 2021 /CNW/ — PsyBio Therapeutics Corp. (TSXV:PSYB) (“PsyBio” or the “Company“), a biotechnology company pioneering the next generation of targeted psychoactive medications, announces today that it has amended its master sponsored agreement with Miami University based in Oxford, Ohio (the “Amended Agreement“) to extend and expand the research efforts of the laboratory of Dr. J. Andrew Jones in […]
VANCOUVER, British Columbia, April 26, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (“Algernon”) a clinical stage pharmaceutical development company, announces that it has filed an end of Phase 2 meeting request (EOP2) with the U.S. Food and Drug Administration (“FDA”), based on the completion of the Phase 2b part […]
Cybin Inc. (NEO:CYBN) (OTCQB:CLXPF) (“Cybin”), a biotechnology company focused on progressing psychedelic therapeutics, today announced that it has successfully demonstrated Proof of Concept for its deuterated tryptamine programs, CYB003 and CYB004, for the treatment of depression and addiction. Multiple long-acting psychedelic treatments have been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration […]
TORONTO, April 20, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (“PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, today announced it submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of […]
VANCOUVER, British Columbia, April 08, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it plans to formalize discussions with the U.S. Food and Drug Administration (“FDA”) by filing an End-of-Phase 2 meeting request (EOP2) based […]
CBD Innovator, HempFusion, Makes Successful Debut on TSX
HempFusion Wellness Inc. (TSX: CBD-U) shares soared over 65% following their successful debut on the Toronto Stock Exchange (TSX) on Wednesday, January 6, 2021. Cannabidiol, or CBD, has become one of the most popular health and wellness products in the world over the past couple of years. According to Research and Markets, the global […]
FDA Approves Landmark COVID/Heart/CBD Clinical Trial
The US Food and Drug Administration (FDA) recently announced a potentially major development in the quest to improve outcomes for COVID-19 patients. The agency approved an Investigational New Drug application by Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) that opens the door for Cardiol to conduct its Phase II/III trial. The trial, designed by leading […]
Trial will take place at major U.S. centers and examine the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease (CVD) Oakville, Ontario–(Newsfile Corp. – September 25, 2020) – Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (“Cardiol” or the “Company“), a clinical-stage biotechnology company focused […]
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In addition to his role as Founder and CEO at MAZAKALI, Sumit is a consultant to The Arcview Group and the Managing Partner of Emerald Ventures. A frequent speaker at investment seminars, Sumit acts as a mentor to Arcview and Canopy companies and serves on the Canopy Investment committee as well as the NCIA Finance […]
Tom Zuber is Zuber Lawler & Del Duca’s Managing Partner. He has a degree with highest honors in biomedical engineering and has advised some of the most iconic companies in the world on their patent and trademark portfolios. He is at the cutting edge of cannabis patent and trademark law. He holds degrees from Harvard University and Columbia Law […]
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