Depression

Kaya Enters Jamaica’s Legal Psilocybin Market

Retrieved on: 
Wednesday, January 11, 2023
Psilocybin, Major depressive disorder, Attention, University, OTC, Depression, Anxiety, Government, Safety, LOS, FDA, University of California, Johns Hopkins University, Marketing, Food, Capsule, Post-traumatic stress disorder, Research, Food and Drug Administration, Pharmaceutical industry, Tourism, New York University

KINGSTON, Jamaica and LOS ANGELES, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Kaya Group ("Kaya" or "the Company") (OTC: NUGL), the first medicinal Ganja herb house in the Caribbean and holistic, wellness-focused ecosystem, announced today its Kaya Extracts subsidiary plans to enter the legal psilocybin market in Jamaica where the laws are relaxed, targeting the multibillion-dollar industry for the development, marketing and distribution of psilocybin mushrooms.

Key Points: 
  • KINGSTON, Jamaica and LOS ANGELES, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Kaya Group ("Kaya" or "the Company") (OTC: NUGL), the first medicinal Ganja herb house in the Caribbean and holistic, wellness-focused ecosystem, announced today its Kaya Extracts subsidiary plans to enter the legal psilocybin market in Jamaica where the laws are relaxed, targeting the multibillion-dollar industry for the development, marketing and distribution of psilocybin mushrooms.
  • This will include Kaya's current rollout of traditional Jamaica Psilocybin Mushroom and Capsules at its Herbhouse locations in Falmouth, Ocho Rios, and Kingston.
  • The first milestone includes developing and launching our nutraceuticals' range of psilocybin concentrations from micro-doses to hallucinogenic levels of dosing.
  • As a leader in the plant-based wellness industry, Kaya is committed to providing high-quality, responsibly sourced psilocybin products.

PharmaTher Holdings Provides Update for KETARX™ (Racemic Ketamine) Development Programs and Expected Milestones for 2023

Retrieved on: 
Wednesday, January 11, 2023
IND, Pump, Brain, R, Sour Patch Kids, Patent, Pharmacology, Pain, CMC, Substance abuse, Mental health, Depression, Levodopa-induced dyskinesia, Amyotrophic lateral sclerosis, CSE, Trial of the century, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Amyotrophy, Chronic pain, Safety, Type, FDA, Risk, Ketamine, Irritation, Neuromuscular disease, Health, Maintenance, ANDA, NDA, IV, Diagnosis, History, Food, Metabolism, Post-traumatic stress disorder, Motor disorder, Life expectancy, Disorder, Chemistry, Suicidal ideation, Movement, USD, Degenerative disease, CGMP, Analgesic, ALS, Pharmaceutical industry, CRPS

TORONTO, Jan. 11, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today provided an update for its clinical development programs and milestones for 2023 with KETARX™ (racemic ketamine) as a potential treatment for mental health, neurological and pain disorders.

Key Points: 
  • Of the three forms of ketamine, only racemic ketamine and S-ketamine products have been approved by FDA.
  • The Company recently completed the development of the microneedle patch system for the intradermal delivery of sustained low-dose ketamine.
  • This milestone has enabled progression toward process validation and the manufacturing of cGMP clinical materials to support ongoing clinical development.
  • Upon completion of the study, PharmaTher aims to seek guidance from the FDA to determine the final clinical development plan.

BrainsWay Announces Extended Private Insurance Coverage in Washington State for the Treatment of OCD and Depression Utilizing Deep TMS™

Retrieved on: 
Wednesday, January 11, 2023
Brainsway, Cigna, Brain, Tic disorder, TMS, Deep, OCD, Depression, FDA, MDD, Medicare, Palmetto, Policy, Patient, Transcranial magnetic stimulation, TASE, Health insurance

This policy extension provides coverage of Deep TMS for OCD to approximately 2.2 million members.

Key Points: 
  • This policy extension provides coverage of Deep TMS for OCD to approximately 2.2 million members.
  • The policy change also reduces major depressive disorder (MDD) TMS coverage criteria from four failed medication trials to only three.
  • In 2021, only 52.6 million U.S. lives were covered for OCD treatment with TMS.
  • Last year, insurers such as Cigna, Highmark BCBS, and Palmetto GBA Medicare extended coverage, increasing the total covered lives to 90.5 million.

National Nonprofit Can’d Aid Serves 85,000 People With Over 100 Local Community Events In 2022

Retrieved on: 
Wednesday, January 11, 2023
Aluminium, Tire tread, Recycling, Steep Canyon Rangers, Ball Corporation, Depression, Anxiety, Ambassador, Movement, Volunteering, Dream, Plastic, School, Toy

Can’d Aid hosted more than 100 projects across the US in 2022 that supported sustainability, disaster relief, and physical health and mental wellness.

Key Points: 
  • Can’d Aid hosted more than 100 projects across the US in 2022 that supported sustainability, disaster relief, and physical health and mental wellness.
  • This year, with the help of 6,000 volunteers and generous corporate sponsors, Can’d Aid was able to serve more than 85,000 people.
  • Since Can’d Aid’s inception in 2013, the nonprofit has built and donated thousands of bikes and skateboards through its Treads + Trails program.
  • Thanks to ongoing fundraising efforts, corporate partnerships, and continued community engagement, Can’d Aid donated 45% more bikes and skateboards year-over-year in 2022.

Psycheceutical Announces Julian Bailes, M.D. as Board Member and Chief Medical Officer

Retrieved on: 
Tuesday, January 10, 2023
Administration, University, Senior advisor, NFL, Pop Warner Little Scholars, Neck, Depression, Anxiety, DEA, NorthShore University HealthSystem, FDA, Matthew Bailes, Intellectual property, NFL Head Coach, TBI, Chronic traumatic encephalopathy, PTSD, Drug discovery, Post-traumatic stress disorder, Research, Barrow Neurological Institute, Traumatic brain injury, Acquisition, NFLPA, CTE, Pharmaceutical industry, Management, Neurosurgery

MIAMI, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) ("Psycheceutical" or the "Company"), a bioscience company dedicated to developing cutting-edge brain delivery technologies for the next generation of mental health treatments, today announced that Dr. Julian Bailes has accepted the role of Chief Medical Officer and will also join the company’s Board of Directors.

Key Points: 
  • MIAMI, Jan. 10, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) ("Psycheceutical" or the "Company"), a bioscience company dedicated to developing cutting-edge brain delivery technologies for the next generation of mental health treatments, today announced that Dr. Julian Bailes has accepted the role of Chief Medical Officer and will also join the company’s Board of Directors.
  • Bailes is an esteemed leader in the fields of neurosurgery and traumatic brain injuries.
  • His expertise in the understanding of CTE was showcased in the 2015 film “Concussion,” starring Will Smith, where Bailes was portrayed by actor Alec Baldwin.
  • The Medical Advisory Board works in tandem with the company’s scientific team in identifying and reviewing outstanding molecules to bring through the drug discovery and development process to clinical application.

Irwin Naturals and Braxia Scientific Announce Partnership for In-Human Clinical Studies Supporting Pharmaceutical Companies in the US

Retrieved on: 
Tuesday, January 10, 2023
Invictus, OTC, LOI, Mental health, Depression, CSE, Government, FRA, FDA, Partnership, Psychiatry, Patient, Letter, Science, Pharmaceutical industry, Emergence

The partnership will bring together Braxia’s expertise, track record of leadership in innovative mental health treatments and current comprehensive clinical research capabilities to 12 Emergence clinics in 5 US states.

Key Points: 
  • The partnership will bring together Braxia’s expertise, track record of leadership in innovative mental health treatments and current comprehensive clinical research capabilities to 12 Emergence clinics in 5 US states.
  • Under the terms of the LOI, Irwin will invest up to $2 million over the next 12 months to launch initial clinical research services beginning with at least 5 clinics in Florida.
  • Irwin and Braxia’s partnership will create a leading mental health focused clinical research platform designed to streamline and accelerate the process of in-human clinical development of new therapies, including seamless patient recruitment through to FDA application.
  • Having an outstanding reputation for scientific expertise, quality clinical research in depression and other mental health disorders areas that will enable us to further develop our US clinical footprint."

Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2023

Retrieved on: 
Monday, January 9, 2023
OLE, Ageing, SCN8A, Depression, Seizure, Icahn School of Medicine at Mount Sinai, Safety, FDA, FOS, MADRS, MPC, MDD, NDA, Grammatical mood, DBP, EPIK, Patient, Neurocrine Biosciences, Epilepsy, MRI, KCNQ2, Anhedonia, Magnetic resonance, Neurocrine, Mount Sinai, Medical imaging, Pharmaceutical industry, Xenon

BURNABY, British Columbia, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined recent progress in its clinical programs and key milestones for 2023.

Key Points: 
  • BURNABY, British Columbia, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today outlined recent progress in its clinical programs and key milestones for 2023.
  • Xenon has initiated a Phase 3 clinical trial, called X-ACKT, to support potential regulatory submissions in an additional epilepsy indication of primary generalized tonic clonic seizures (PGTCS).
  • The primary efficacy endpoint is the MPC in monthly PGTCS frequency from baseline through the DBP of XEN1101 compared to placebo.
  • Pursuant to the terms of the agreement, Xenon has the potential to receive certain clinical, regulatory, and commercial milestone payments, as well as future sales royalties.

Bright Minds Biosciences Announces Resignation of Board Member

Retrieved on: 
Monday, January 9, 2023
Depression, CSE, PTSD, Therapy, Epilepsy, Pain, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced that Dr. Doug Williamson has resigned from its Board of Directors.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced that Dr. Doug Williamson has resigned from its Board of Directors.
  • Dr. Williamson has accepted a new full-time role that precludes his participation on the Bright Minds Board.
  • We wish him well in his new endeavors,” stated Ian McDonald, CEO and Co-founder of Bright Minds Biosciences.
  • “It has been an honor to serve on the Bright Minds Board.

Reunion Neuroscience Inc. Completes Interim Data Analysis for Phase 1 Clinical Trial with Novel Serotonergic Psychedelic RE104

Retrieved on: 
Monday, January 9, 2023
Psilocybin, IND, Psychopharmacology, Data, ACS, Emmanuel Berl, Depression, Mental health, Anxiety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacokinetics, Safety, Reunion, TSX, FDA, SRC, The New England Journal of Medicine, Food, Patient, Drug discovery, Data analysis, Pharmaceutical industry

RE104 is a proprietary, novel serotonergic psychedelic compound that Reunion is developing as a potential fast-acting and durable treatment for patients suffering from postpartum depression and other mental health conditions.

Key Points: 
  • RE104 is a proprietary, novel serotonergic psychedelic compound that Reunion is developing as a potential fast-acting and durable treatment for patients suffering from postpartum depression and other mental health conditions.
  • In this first-in-human, Phase 1 study, RE104 was shown to be safe and well tolerated, with no serious or severe adverse events.
  • The interim analysis included 32 healthy volunteers across four ascending dose cohorts, with two of the eight subjects in each cohort receiving placebo.
  • While completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee (SRC), Reunion has continued with dose escalation and initiated a fifth cohort.

First Patient Dosed in Small Pharma’s Phase I Study Exploring Intramuscular Administration of SPL026

Retrieved on: 
Monday, January 9, 2023
IM, United Kingdom, Mental health, Depression, Pharmacokinetics, Safety, IV, Patient, Chief scientific officer, Phase, Physician, Pharmaceutical industry

This study seeks to identify a target dose of SPL026, administered via IM injection, that is well tolerated and delivers a consistent breakthrough psychedelic experience.

Key Points: 
  • This study seeks to identify a target dose of SPL026, administered via IM injection, that is well tolerated and delivers a consistent breakthrough psychedelic experience.
  • It is reflected in our decision to focus on short-duration psychedelics delivered through different administration routes, with the goal of maximizing patient reach and convenience.
  • With the Phase IIa study of IV SPL026 in Major Depressive Disorder now completed, and results anticipated very soon, we are a step closer to understanding the potential efficacy of SPL026 as a depression treatment.
  • These proof-of-concept results, combined with the results of our other SPL026 studies, will help guide our future clinical development and commercialization strategy.”