Health Canada

Cybin Announces FDA Investigational New Drug Authorization of Cybin’s Sponsored Feasibility Study Using Kernel Flow Technology

Retrieved on: 
Tuesday, October 26, 2021
Mental Health, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Safety, Magnetic resonance imaging, Head, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Goal, Electroencephalography, EDGAR, View, Psilocybin, NYSE, Food, Lists of diseases, Health Canada, U.S. Securities and Exchange Commission, Inc., Time, Brain, Forward-looking statement, Investigational New Drug, Company, Electrode, NEO, NYSE American, COVID-19, Growth, News, Acquisition, Therapy, Risk, Pharmaceutical industry, Medical imaging

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (Cybin or the Company), a biotechnology company focused on progressing psychedelic therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to proceed with the Companys sponsored feasibility study using Kernels Flow technology to measure ketamines psychedelic effect on cerebral cortex hemodynamics.

Key Points: 
  • Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (Cybin or the Company), a biotechnology company focused on progressing psychedelic therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to proceed with the Companys sponsored feasibility study using Kernels Flow technology to measure ketamines psychedelic effect on cerebral cortex hemodynamics.
  • With Kernel Flow, Cybin's researchers can start putting numbers and quantification to subjective states of mind, including altered ones.
  • As part of Cybins sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings.
  • If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Delic Announces Partnership with GT Research

Retrieved on: 
Tuesday, October 26, 2021
UBC, Compliance, Cannabis, Research, Biotechnology, Tripura Merger Agreement, University, DELC, Genome, Industry, Failure, IP, Canadian Securities Exchange, Quality control, Transaction, Person, Partnership, CSE, GTR, Patient, Legislation, Private Securities Litigation Reform Act, Psilocybin, Health Canada, Mergers and acquisitions, Nature, Company, Phrase, CEO, Regulation, COVID-19, Metabolomics, Growth, Multimedia, News, Health, Acquisition, Intellectual property, Reality Sandwiches, Education, FRA, Genetics, DNA, Drug, Pharmaceutical industry, Risk management, Bookkeeping

Delic Labs is a federally authorized psilocybin and cannabis research laboratory focused on extraction, analytical testing, and chemical process development.

Key Points: 
  • Delic Labs is a federally authorized psilocybin and cannabis research laboratory focused on extraction, analytical testing, and chemical process development.
  • Matt Stang, co-founder and CEO of Delic Corp, stated, "GT Research is a leader in biotechnology and one of the foremost experts on genetics," said Matt Stang, Delic CEO and co-founder.
  • Delic Labs is also a leading cannabis analytical and research company boasting clients that include some of the largest brands in the world.
  • Delic Labs is a federally licensed cannabis and psilocybin research laboratory focused on extraction optimization, analytical testing, and process development.

Antiviral Canadian Medical Products deactivate 99.9%+ of COVID-19 in 5 minutes: University of Toronto Testing Lab

Retrieved on: 
Tuesday, October 26, 2021
University, REAL, Atlas, Virus, Health Canada, Severe acute respiratory syndrome coronavirus 2, Time, Good Smartphone Activated Medics, COVID-19, Laboratory, CL3, GLOBE, Department, Vaccine

MIRABEL, Quebec, Oct. 26, 2021 (GLOBE NEWSWIRE) -- i3 BioMedical Inc. (www.i3biomedical.com) achieves the fastest and most efficient killing speed of SARS-CoV-2.

Key Points: 
  • MIRABEL, Quebec, Oct. 26, 2021 (GLOBE NEWSWIRE) -- i3 BioMedical Inc. (www.i3biomedical.com) achieves the fastest and most efficient killing speed of SARS-CoV-2.
  • TrioMed sets the unequalled standard of superiority in Active protection worldwide.
  • The Virucidal technology developed by i3 BioMedical Inc. was confirmed to deactivate more than 99.9% of SARS-CoV-2 the virus that causes COVID-19 on the outer surface of the TrioMed Active Medical products (including mask) in 5 minutes after 8 hours of simulated usage, according to independent virology tests conducted at the University of Toronto.
  • Scientists, led by Professor Scott Gray-Owen of the Department of Molecular Genetics at U of Ts Temerty Faculty of Medicine, used the Facultys high-tech containment level three (CL3) lab to test the efficacy of the protective layer of TrioMed Active Medical products.

Specialty Enzymes & Probiotics is pleased to announce SEBtilis™ received a No Objections Letter from the FDA for its GRAS submission. GRAS stands for Generally Recognized As Safe.

Retrieved on: 
Monday, October 25, 2021
Safety, Probiotic, Lipid metabolism, Research, Specialty, Disease, Bacillus subtilis, History, FDA, GRAS, Refrigeration, Food, Health Canada, Bacillus, Food and Drug Administration, Multimedia, Dietary supplement

A spore-forming, shelf-stable probiotic, SEBtilis (Bacillus subtilis), creates a protective endospore around itself that allows it to survive the journey to the gut, where it thrives.

Key Points: 
  • A spore-forming, shelf-stable probiotic, SEBtilis (Bacillus subtilis), creates a protective endospore around itself that allows it to survive the journey to the gut, where it thrives.
  • It is also able to withstand manufacturing and distribution practices without refrigeration, saving manufacturer resources.
  • *
    Studies show SEBtilis (Bacillus subtilis) promotes intestinal homeostasis, the production of antimicrobials targeting pathogenic organisms, lipid metabolism, normal oxidative stress levels, and immune health.
  • *
    SEBtilis (Bacillus subtilis) has also received approval as a natural health product by Health Canada.

Cardiol Therapeutics Receives Health Canada Approval for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis

Retrieved on: 
Monday, October 25, 2021
Safety, Death, Cancer, Heart, Research, Myocarditis, Chest pain, CVD, Prognosis, Degenerative disease, University, Vaccine, McGill University Health Centre, University of Pittsburgh Medical Center, Mayo Clinic, History, Infection, Patient, Adoption, NASDAQ, FDA, Cardiovascular disease, Food, Cleveland, Health Canada, TSX, Risk, Regulation of tobacco by the U.S. Food and Drug Administration, Cleveland Clinic, Investigational New Drug, Company, Steroid, CRDL, COVID-19, Inflammation, Muscle tissue, Clinical professor, IND, Cannabidiol, Program, News, Therapy, Mortality, Hospital, Holy Spirit Hospital (Berlin), University of Ottawa Heart Institute, Houston Methodist Hospital, Desun Hospital & Heart Institute, Heart failure, Pharmaceutical industry

In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation.

Key Points: 
  • In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation.
  • Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19.
  • Cardiol's acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe.
  • Given the risk of significant heart failure associated with acute myocarditis, current intervention includes drugs commonly administered for heart failure.

Spectral to Present at the Benzinga Global Small Cap Conference on October 27, 2021

Retrieved on: 
Monday, October 25, 2021
Market capitalization, RRT, Patient, FDA, Sepsis, Toronto Stock Exchange, Health Canada, TSX, Risk, SAMI, U.S. FDA, Conference, PMX, EDT, Federal Food, Drug, and Cosmetic Act, News, Septic shock, GLOBE, Renal replacement therapy, Medical device, Pharmaceutical industry

TORONTO, Oct. 25, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (Spectral or the Company) (TSX: EDT) and its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced that Chris Seto, Chief Executive Officer of Spectral, will present at the Benzinga Global Small Cap Conference which is being held virtually on October 27-28, 2021.

Key Points: 
  • TORONTO, Oct. 25, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (Spectral or the Company) (TSX: EDT) and its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced that Chris Seto, Chief Executive Officer of Spectral, will present at the Benzinga Global Small Cap Conference which is being held virtually on October 27-28, 2021.
  • Mr. Seto is scheduled to present on Wednesday, October 27th at 3:20 pm Eastern Time / 12:20 pm Pacific Time.
  • The Benzinga Global Small Cap Conference bridges the gap between Small Cap companies, investors, and traders.
  • Learn about small cap investing with clearly defined Educational Modules, take a look at a curated group of Small Cap investment opportunities, and connect with the global Small Cap audience in an intimate, virtual setting.

Catalyst Pharmaceuticals to Report Third Quarter 2021 Financial Results on November 9, 2021

Retrieved on: 
Monday, October 25, 2021
CORAL, United, Catalyst Pharmaceuticals, Myasthenia gravis, Amifampridine, New Drug Application, Patient, Investor, FDA, Health Canada, SEC, Adult, Annual report, Forward-looking statement, Company, Webcast, Degenerative disease, Tablet, Nasdaq, GLOBE, Orphan, LEMS, Pharmaceutical industry

Catalyst's management team will host a conference call and webcast the following morning, Wednesday, November 10, 2021, at8:30 AM EST to discuss the Company's financial results and provide a corporate update.

Key Points: 
  • Catalyst's management team will host a conference call and webcast the following morning, Wednesday, November 10, 2021, at8:30 AM EST to discuss the Company's financial results and provide a corporate update.
  • A replay of the webcast will be available on the Catalyst website for 30 days following the date of the event.
  • Catalyst Pharmaceuticalsis a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases.
  • Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Braxia Scientific Featured in National News, W5 Canada's Most-Watched Documentary Series, Providing Access and Promoting Use of Ketamine to Treat Brain-Based Illnesses

Retrieved on: 
Friday, October 22, 2021
Depression, Lists of diseases, Ketamine, Rapids, Controlled Drugs and Substances Act, TRD, Person, CSE, Psilocybin, Ta' Braxia Cemetery, Health Canada, Removal of cannabis from Schedule I of the Controlled Substances Act, Toronto Life, Forward-looking statement, Drug prohibition law, Company, CTV, OTC, Multimedia, FWB, News, Euro-Excellence Inc v Kraft Canada Inc, Risk, Chief scientific officer, Disorder, CDSA, Pharmaceutical industry, Audit

Braxia Scientific CEO Dr. Roger McIntyre will be featured on CTV's W5, Canada's most-watched current affairs and documentary program.

Key Points: 
  • Braxia Scientific CEO Dr. Roger McIntyre will be featured on CTV's W5, Canada's most-watched current affairs and documentary program.
  • Braxia Scientific and the Canadian Rapid Treatment Center of Excellence (CRTCE), a wholly owned subsidiary, are also highlighted in a recent article by Toronto Life , a monthly magazine.
  • Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders.
  • Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others.

U.K. Tobacco Wholesalers Enthusiastic About TAAT™ Following Arrival of First Commercial Shipment

Retrieved on: 
Friday, October 22, 2021
NOR, Taste, Disease, Tobacco, THE, Pedigree, Food, Health Canada, Regulation of tobacco by the U.S. Food and Drug Administration, United Kingdom, Company, Phrase, Intention, Growth, Environment, News, Tobacco industry, Risk, THIS, Legislation, Risk management

TAAT's base material is Beyond Tobacco, a proprietary blend which undergoes a patent-pending refinement technique causing its scent and taste to resemble tobacco.

Key Points: 
  • TAAT's base material is Beyond Tobacco, a proprietary blend which undergoes a patent-pending refinement technique causing its scent and taste to resemble tobacco.
  • Under executive leadership with "Big Tobacco" pedigree, TAAT was launched first in the United States in Q4 2020 as the Company seeks to position itself in the $814 billion1 global tobacco industry.
  • Forward-looking information in this news release includes statements regarding the anticipated performance of TAAT in the tobacco industry, in addition to the following: Potential outcomes from the Companys dialogues with tobacco wholesalers, and completion of the Companys first container shipment of TAAT to the United Kingdom.
  • Disclosures relating to investor relations firms retained by TAAT Global Alternatives Inc. can be found under the Company's profile on http://sedar.com .

Adtralza® (tralokinumab) Achieves Primary and Secondary Endpoints in Phase 3 Trial of Adolescents With Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, October 22, 2021
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Safety, Science, Atopic dermatitis, MD, Leo Pharma, Quality of life, Research, Disease, Poster, Dermatology, Tralokinumab, Ageing, Adolescence, Patient, Overalls, Chair, EASI, Health Canada, LEO, European Commission, Conference, Dermatitis, Royal commission, Adult, DKK, IGA, NRS, Skin, SCORAD, AES, Development, MHRA, Department, Pharmaceutical industry, Vaccine, Copper, Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, the ECZTRA 6 Trial, atopic dermatitis, LEO Pharma, THE ECZTRA 6 TRIAL, ATOPIC DERMATITIS, LEO PHARMA

These findings are encouraging, as moderate-to-severe atopic dermatitis can have major physical and psychosocial impacts on adolescents who have limited options for long-term treatment.

Key Points: 
  • These findings are encouraging, as moderate-to-severe atopic dermatitis can have major physical and psychosocial impacts on adolescents who have limited options for long-term treatment.
  • This is an important milestone for the overall ECZTRA clinical trial program as we expand studies to include younger patients.
  • Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial.
  • Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no.