MDD

BetterLife Announces Closing of $1.168 Million Convertible Debentures to Further Advance IND-enabling Studies of its Non-hallucinogenic LSD-based Drug Candidate BETR-001

Retrieved on: 
Wednesday, April 3, 2024
GAD, Metabolism, MDD, LSD, Patient, Research, Lysergic acid diethylamide, DSM-IV codes, IND, Hallucination, Safety, GLP, Multilateral, Medical device

The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.

Key Points: 
  • The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.
  • Dr. Ahmad Doroudian, CEO of BetterLife, commented, “We are very encouraged with FDA’s recent decision to grant breakthrough therapy designation to LSD for generalized anxiety disorder (GAD) patients.
  • In simple words, we believe BETR-001 will deliver all the therapeutic benefits of LSD without its side effects.”
    BetterLife issued a total of $1.168 million 10% convertible debentures (the “Convertible Debentures”).
  • $800,000 of the Convertible Debentures mature on March 27, 2026 and $368,000 mature on April 1, 2026.

BrainsWay Announces Positive Results in Late-Life Depression Post-Marketing Analysis

Retrieved on: 
Thursday, March 28, 2024
Depression, Deep, Brainsway, Medicine, Safety, MDD, Patient, Ageing, TMS, Journal, Doctor of Philosophy, DSM-IV codes, Efficacy, Mixed anxiety–depressive disorder, Atrophy, Scalp, FDA, Pharmaceutical industry

The post-marketing study demonstrated real-world outcomes for older adults (60-91 years of age) suffering from major depressive disorder (MDD).

Key Points: 
  • The post-marketing study demonstrated real-world outcomes for older adults (60-91 years of age) suffering from major depressive disorder (MDD).
  • In the study, data was analyzed from 247 depression patients at 16 clinical sites in this age group who had been treated with BrainsWay’s proprietary H1 Coil.
  • The outcomes were comparable to those reported in a post-marketing analysis of over 1,350 patients published in 2023.
  • This can make it challenging for certain non-invasive technologies to reach the brain areas involved in depression,” said Colleen Hanlon, PhD, Vice President of Medical and Clinical Affairs at BrainsWay.

Healis Therapeutics announces collaboration with Massachusetts General Hospital (MGH) and affiliates of Harvard Medical School to advance clinical-stage neuroscience research

Retrieved on: 
Tuesday, March 26, 2024
MGH, Harvard Medical School, Public health, Mass General Brigham, Massachusetts General Hospital, MDD, Patient, Public, Roche, Research, Merck, Social anxiety disorder, DSM-IV codes, Bristol Myers Squibb, Clinical trial, Neuropsychiatry, HMS, World Health Organization, Therapy, Hospital, Safety, WHO, SAD, Major depressive disorder, PTSD, Mass, Pharmaceutical industry

Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).

Key Points: 
  • Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).
  • “We continue to observe very significant need in the neuropsychiatric patient population,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics.
  • “MDD remains a public health challenge around the world,” said Erik Van Widenfelt, Head of Clinical Trials at Healis Therapeutics.
  • General Hospital (MGH) and Harvard Medical School,” said Sebastian De Beurs, Co-Founder of Healis Therapeutics.

Denovo Biopharma Announces a Major Breakthrough in Treatment‑Resistant Depression with Precision Medicine

Retrieved on: 
Tuesday, April 9, 2024
Professional Services, Mental Health, Health, Venture Capital, Clinical Trials, Pharmaceutical, Biotechnology, Dopamine, Depression, Liafensine, SDS, Serotonin, MDD, Patient, CNS, Biomarker, DSM-IV codes, Overalls, Medicine, TRD, Safety, Norepinephrine, MADRS, Pharmaceutical industry

Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced positive results for its biomarker‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD).

Key Points: 
  • Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced positive results for its biomarker‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD).
  • More than 23 million people in the U.S. alone suffer from major depressive disorder (MDD).
  • TRD remains a highly unmet medical need indication as there are few approved pharmacological agents for TRD and overall, outcomes remain poor.
  • Using its unique big data based Denovo Genomic Marker (DGM™) biomarker platform, Denovo discovered a novel genetic biomarker, termed DGM4™, which was hypothesized to predict liafensine’s efficacy in TRD patients.

NeuroStar® Advanced Therapy Receives FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression

Retrieved on: 
Monday, March 25, 2024
Depression, Prevalence, Data analysis, MDD, COVID-19, Patient, Education, Ageing, Transcranial magnetic stimulation, TMS, DSM-IV codes, Quality of life, Adolescence, Safety, Marketing, STIM, FDA, Parent, Food, Pharmaceutical industry

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.

Key Points: 
  • NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.
  • "The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic.
  • "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults.
  • This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."

ABVC BioPharma, Inc. CEO Selected as 2024 Top 10 CEO in CEO Insights Asia Magazine

Retrieved on: 
Tuesday, March 19, 2024
Organization, Growth, ADHD, MDD, CNS, Social media, Patent, Ophthalmology, Management

FREMONT, CA, March 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, proudly announced today that its CEO, Dr. Uttam Patil, was selected as one of the Top 10 CEOs in Taiwan 2024 by CEO Insights Asia Magazine .

Key Points: 
  • FREMONT, CA, March 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, proudly announced today that its CEO, Dr. Uttam Patil, was selected as one of the Top 10 CEOs in Taiwan 2024 by CEO Insights Asia Magazine .
  • Dr. Patil is confident in the Company's prospects, so he owns stock options without claiming a salary.
  • CEO Insights Asia writes that Dr. Patil, "a unique amalgamation of scholarly acumen and practical insight fuels a forward-thinking approach, steering companies toward sustained success and pioneering innovation ( CEO Insight Asia 19) ".
  • ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, March 19, 2024
Depression, MDD, Central nervous system, Patient, CNS, DSM-IV codes, Therapy, Safety, MADRS, Pharmaceutical industry

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

Key Points: 
  • NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).
  • PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults.
  • Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks.
  • The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS).

ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update

Retrieved on: 
Thursday, March 14, 2024
SIV, Data, Combination, EGFR, Property, SPI, Patient, Sale, Attention deficit hyperactivity disorder, Syndrome, Lung cancer, IND, Myelodysplastic syndrome, Bank statement, Investment, Note, European, TNBC, ADHD, GAP, BioLite, DSM-IV codes, GMP, Investigational New Drug, MDS, Common stock, UCSF, NSCLC, Dietary supplement, Research, Good manufacturing practice, Cancer, University, Security (finance), Pancreatic cancer, Drug development, TGA, FDA, Map, Consultant, Variable, Toxicity, Metastasis, Patent, MDD, Triple-negative breast cancer, License, Long-term care, Net, US FDA, Pharmaceutical industry

As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).

Key Points: 
  • As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).
  • The Company entered a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd. (“Zhonghui”).
  • On February 06, 2024, ABVC acquired an additional real estate asset via an equity transfer of 703,495 shares at $3.50 per share to develop plant factories for ABVC’s botanical pipeline.
  • ABVC hopes the property will ultimately be used as an integrated platform for the global development of the Asian healthcare business and the medical, pharmaceutical, and biotechnology industries.

Alto Neuroscience Announces Initiation of Phase 2 Study of ALTO-203 in Patients with Major Depressive Disorder

Retrieved on: 
Wednesday, April 3, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Alertness, Depression, EEG, Motivation, ClinicalTrials.gov, MDD, Patient, Neuroscience, Anhedonia, H3, Pleasure, Alto, Cognition, Safety, Pharmacokinetics, Pharmaceutical industry

Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced the initiation of its Phase 2 double-blind, single- and multiple-dose study to determine the pharmacodynamic effects of ALTO-203 in MDD patients as well as assess its safety, tolerability, and pharmacokinetics.

Key Points: 
  • Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced the initiation of its Phase 2 double-blind, single- and multiple-dose study to determine the pharmacodynamic effects of ALTO-203 in MDD patients as well as assess its safety, tolerability, and pharmacokinetics.
  • The present study will evaluate these effects in patients with MDD to determine the potential of ALTO-203 as an antidepressant.
  • “In a Phase 1 study, ALTO-203 demonstrated an acute increase in positive emotion relative to placebo and across several dosage levels.
  • This Phase 2 study consists of two sequential double-blind, placebo-controlled treatment periods and examines two doses of ALTO-203 and placebo given as monotherapy in patients with MDD.

Cathy Nguyen Named Provider of the Month at Relief Mental Health in Chicago

Retrieved on: 
Tuesday, April 2, 2024
Men, Research, General Health, LGBTQ+, Pharmaceutical, Consumer, Mental Health, Science, Neurology, Biotechnology, Women, Seniors, Health, Depression, Mental health, Brain, MDD, Empathy, Patient, Transcranial magnetic stimulation, TMS, Bipolar disorder, Anxiety, OCD, Cathy, Month, DSM-IV codes, Provider, MSN, TRD, Suicidal ideation, Field line, Esketamine, FDA, Nursing

Relief Mental Health , a leading outpatient provider of transcranial magnetic stimulation (TMS), psychedelic therapy, psychiatric medication management, and talk therapy, is thrilled to announce Psychiatric Nurse Practitioner Cathy Nguyen, MSN APRN PMHNP-BC as its esteemed Provider of the Month.

Key Points: 
  • Relief Mental Health , a leading outpatient provider of transcranial magnetic stimulation (TMS), psychedelic therapy, psychiatric medication management, and talk therapy, is thrilled to announce Psychiatric Nurse Practitioner Cathy Nguyen, MSN APRN PMHNP-BC as its esteemed Provider of the Month.
  • Nguyen has exhibited exceptional dedication and expertise in providing innovative mental health care to the community at Relief’s West Loop clinic in Chicago.
  • Susan Mueller, CEO of Relief Mental Health, expressed her admiration for Nguyen’s commitment to the organization’s core values.
  • To make an appointment with Nguyen or for more information about the innovative services offered at Relief Mental Health, call 855.205.4764, email [email protected] or visit reliefmh.com .