Acetylcholine

Vagus nerve activation of the spleen shows promise to treat infections, Feinstein Institutes research

Retrieved on: 
Friday, April 26, 2024
Biotechnology, Managed Care, Health, General Health, Pharmaceutical, Health Technology, Other Science, Research, Hospitals, Science, Clinical Trials, Diamond, Autoantibody, Cancer, Bangladesh Technical Education Board, Inflammation, Biomedical engineering, National academy, National Academy of Sciences, Mouse, Crohn's disease, Pulmonary hypertension, Map, Science Advances, Vagus nerve stimulation, Inflammatory Bowel Diseases, Diabetes, Interface (computing), Neuroscience, Acetylcholine, Doctor of Philosophy, Spleen, VNS, DRS, Disease, Anatomy, Human, Sensation, Autoimmune disease, Nervous system, Arthritis, Molecular medicine, Physiology, Medicine, Immunology, Medical research, Multimedia, Lupus, Immune system, Antibody, Paralysis, Immunity, Credit, Autoimmunity, Sepsis, Vagus nerve, Vaccine

New research published in Science Advances by The Feinstein Institutes for Medical Research scientists shows that activation of the vagus nerve triggers the spleen, thereby regulating the production of antibodies.

Key Points: 
  • New research published in Science Advances by The Feinstein Institutes for Medical Research scientists shows that activation of the vagus nerve triggers the spleen, thereby regulating the production of antibodies.
  • This research highlights how the nervous system regulates immunity and suggests potential for non-pharmalogical, vagus nerve modulation to treat a variety of diseases, like lupus and sepsis.
  • Dr. Zanos’s research focus is on understanding the anatomy and physiology of the vagus nerve and the effects vagus nerve stimulation has in inflammation and cardiovascular diseases.
  • At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury.

Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q4 and FY2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Janus, Research, MMN, Myasthenia gravis, Dianthus, GMG, CIDP, Half-life, Form, Patient, Complement component 1s, Magenta, Acetylcholine, American Academy, CMC, G&A, YTE, Drug, AAN, Investment, Therapy, PIPE, Magic, Multifocal motor neuropathy, Annual general meeting, Pharmaceutical industry

NEW YORK and WALTHAM, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the fourth quarter and full year ending December 31, 2023, and provided an update on recent business achievements.

Key Points: 
  • DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need.
  • Initial top-line results from this trial are anticipated to be available in the second half of 2025.
  • Dianthus successfully completed a private investment in public equity (“PIPE”) financing in January 2024 that resulted in gross proceeds of approximately $230 million.
  • Additional Information – For additional information on the Company’s financial results for the year ended December 31, 2023, please refer to the Form 10-K filed with the SEC.

Dianthus Therapeutics Announces Initiation of Phase 2 MaGic Trial of DNTH103 In Generalized Myasthenia Gravis (gMG)

Retrieved on: 
Monday, February 26, 2024
Therapy, QMG, FDA, Dianthus, Food, Acetylcholine, Magic, Neurology, Safety, Myasthenia, University, GMG, Food and Drug Administration, Myasthenia gravis, Patient, Complement component 1s, Half-life, IND, Pharmaceutical industry

NEW YORK and WALTHAM, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced the initiation of the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis. The initiation follows U.S. Food and Drug Administration (FDA) clearance of the Phase 2 Investigational New Drug (IND) application for DNTH103. Top-line results from this trial are anticipated in the second half of 2025.

Key Points: 
  • The initiation follows U.S. Food and Drug Administration (FDA) clearance of the Phase 2 Investigational New Drug (IND) application for DNTH103.
  • Top-line results from this trial are anticipated in the second half of 2025.
  • “Following our encouraging Phase 1 data demonstrating a 60-day half-life and potent, specific classical pathway inhibition, we are excited to rapidly advance DNTH103, our investigational active C1s inhibitor, into a Phase 2 study in generalized Myasthenia Gravis,” said Simrat Randhawa, M.D., Chief Medical Officer of Dianthus Therapeutics.
  • Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

TauRx to Present Two-Year Data from Phase III Trial of HMTM in Alzheimer’s Disease at the AD/PD™ 2024 Conference in March

Retrieved on: 
Monday, February 5, 2024
Research, Mental Health, Neurology, Clinical Trials, Other Health, General Health, Pharmaceutical, Health, Science, Other Science, Multimedia, Memory, Acetylcholine, Tau, Pathology, Entrepreneurship, Disease, Brain, Abstract, Dementia, Conference, Pharmaceutical industry

TauRx Pharmaceuticals Ltd., a global leader in Tau-based research in Alzheimer’s disease (AD), announced today that the company will present the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM) at the upcoming AD/PD™ 2024 Alzheimer's & Parkinson's Diseases Conference from 5-9 March 2024, in Lisbon, Portugal.

Key Points: 
  • TauRx Pharmaceuticals Ltd., a global leader in Tau-based research in Alzheimer’s disease (AD), announced today that the company will present the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM) at the upcoming AD/PD™ 2024 Alzheimer's & Parkinson's Diseases Conference from 5-9 March 2024, in Lisbon, Portugal.
  • If approved, HMTM will be the first oral, anti-tau therapy with a robust safety profile requiring minimal testing and treatment monitoring.
  • HMTM is primarily a tau aggregation inhibitor, which effectively crosses the blood brain barrier to target the source of this damaging process.
  • Its secondary pharmacological action is symptomatic through increasing acetylcholine levels in parts of the brain essential for memory functions.

Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vyvgart, efgartigimod alfa, Date of authorisation: 10/08/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Nuceiva, botulinum toxin type a, Date of authorisation: 27/09/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Nuceiva, botulinum toxin type a, Date of authorisation: 27/09/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nuceiva, botulinum toxin type a, Date of authorisation: 27/09/2019, Revision: 6, Status: Authorised

COVID-19’s impact on the vagus nerve, inflammatory reflex & long COVID: Feinstein Institutes & Karolinska Institutet study outlines potential therapies

Retrieved on: 
Wednesday, November 29, 2023
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View the full release here: https://www.businesswire.com/news/home/20231129335345/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231129335345/en/
    Dr. Kevin J. Tracey co-authored a new paper on the relationship between SARS-CoV-2 and the vagus nerve.
  • They also discussed potential therapies, particularly to reduce the progression of COVID-19 in infected patients as well as long COVID-19 treatment options.
  • “Studying the connection between COVID-19 and the vagus nerve is an important research avenue that needs further study,” said Dr. Andersson.
  • At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury.

Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE®

Retrieved on: 
Friday, October 13, 2023
Lambert–Eaton myasthenic syndrome, Physician, Antibody, Food, Malignancy, Calcium, Shanda, Comorbidity, Nerve, Acetylcholine, Amifampridine, Disease, CORAL, FDA, LEMS, Catalyst Pharmaceuticals, New Drug Application, Carcinoma, Agency, PDUFA, Tablet, Patient, Muscle weakness, Catalysis

CORAL GABLES, Fla., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today announced that the U.S. Food and Drug Administration ("FDA" or "Agency") has accepted for review the Company's supplemental New Drug Application ("sNDA") to increase the indicated maximum daily dosage of FIRDAPSE® (amifampridine) Tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024. FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to seventeen.  

Key Points: 
  • The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024.
  • FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to seventeen.
  • We look forward to working collaboratively with the Agency during the application review process."
  • These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine.

Global Royal Jelly Market Report 2023: Size, Market Share, Applications, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2021-2031 - ResearchAndMarkets.com

Retrieved on: 
Monday, October 16, 2023
Retail, Health, Agriculture, Natural Resources, Pharmaceutical, Vitamins, Supplements, Food, Beverage, Infection, Asthma, Obesity, Cholesterol, Anxiety, Prevalence, Hypotension, Wound healing, Nervous system, Growth, Allergy, Vitamin, Immune system, Acetylcholine, Dicarboxylic acid, Mineral, Infertility, Anaphylaxis, Drug, Food preservation, Marketing, Royal jelly

The "Royal Jelly Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2023 to 2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Royal Jelly Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2023 to 2031" report has been added to ResearchAndMarkets.com's offering.
  • The global royal jelly market is experiencing significant demand driven by various factors.
  • What are the key micro and macro environmental factors that are impacting the growth of Royal Jelly market?
  • Who are the key competitors and what are their key strategies to enhance their market presence in the Royal Jelly market worldwide?