European Academy of Neurology

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Friday, December 15, 2023
Pharmaceutical, Science, Health, Research, Peripheral nervous system, European Commission, European Academy of Neurology, Research and development, Chronic inflammatory demyelinating polyneuropathy, European Medicines Agency, Disease, Clinical trial, EMA, Patient, European, CHMP, Marketing, Committee, Caregiver, Advanced Therapy Medicinal Product, CIDP, Neurology, Recombinant, IGS, IVIG, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
  • This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.
  • HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.

BrainTale Has Presented at the European Academy of Neurology and the World Parkinson Congress the Interest of Its Digital Biomarker Platform for the Early and Differential Diagnosis of Parkinson's Disease

Retrieved on: 
Friday, July 7, 2023
Health, Neurology, General Health, Research, Science, Pharmaceutical, Biotechnology, EAN, CET, PD, Hospital, Ageing, European Academy of Neurology, Multiple system atrophy, Brain, Biomarker, Incidence, Neuroscience, Professor, Parkinson's disease, Patient, Myenteric plexus, Neuroradiology, Parkinsonism, White matter, Diffusion, Basal ganglia, Tauopathy, PSP, Disease, Medical imaging

Vincent Perlbarg, co-founder, scientific director and president of BrainTale, has presented the results supporting the interest of BrainTale’s digital biomarker platform for the care of patients suffering from the disease and the development of new therapies.

Key Points: 
  • Vincent Perlbarg, co-founder, scientific director and president of BrainTale, has presented the results supporting the interest of BrainTale’s digital biomarker platform for the care of patients suffering from the disease and the development of new therapies.
  • Accordingly, since its creation in 2018, BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools for patients suffering from brain diseases.
  • These preliminary data highlight the relevance and sensitivity of BrainTale’s white matter biomarkers to Parkinsonian syndromes, including early stages of Parkinson's disease.
  • The entire BrainTale team is highly committed to providing our solutions to all stakeholders," adds Vincent Perlbarg, co-founder, president and Chief Scientific Officer of the company.

Mitsubishi Tanabe Pharma America Highlights Latest Research in Parkinson's Disease at EAN and WPC 2023 Congresses

Retrieved on: 
Wednesday, July 5, 2023
Mitsubishi Tanabe Pharma, Abstract, EAN, Medical Affairs Bureau, PD, Convention, European Academy of Neurology, Boundless, Beyond, WPC, Hospice, Congress, MTPA, Parkinson's disease, National Primate Research Exhibition Hall, Patient, CEST, World Parkinson Congress, L-DOPA, Safety, Pharmaceutical industry

"We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations."

Key Points: 
  • "We're excited to share our progress with the global scientific community, including the presentation of key findings from a number of clinical trials evaluating ND0612 in people with Parkinson's disease experiencing motor fluctuations."
  • Clinical development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), MTPA's parent company.
  • If regulatory approval for ND0612 is obtained, MTPA intends to commercialize the therapy in the U.S.
  • Onset of efficacy with continuous, subcutaneous levodopa/carbidopa infusion in patients with PD experiencing motor fluctuations

New Analysis of MRI Findings Shows UPLIZNA® (inebilizumab-cdon) Reduced the Formation of Subclinical Spinal Cord Lesions in People With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Friday, June 30, 2023
Research, Radiology, Pharmaceutical, Optical, Medical Devices, Clinical Trials, Science, Biotechnology, Neurology, FDA, Other Science, Health, EAN, OLP, Civil service commission, ANVISA, Spinal cord, RCP, European Academy of Neurology, Prognosis, NMOSD, MRI, Congress, European Academy of Allergy and Clinical Immunology, European Commission, Patient, Physician, Optic nerve, Brazilian Health Regulatory Agency, Horizon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry, Medical imaging

This analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.

Key Points: 
  • This analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.
  • Results from this post-hoc analysis demonstrate that UPLIZNA effectively reduced the formation of subclinical MRI lesions, while also showing an association between subclinical spinal cord lesions and future attacks.
  • Subsequent MRI findings showed that the formation of these lesions decreased as treatment with UPLIZNA continued.
  • Interestingly, these findings showed that subclinical lesions were associated with domain-specific attacks in the following year.

TG Therapeutics Announces Presentation of Exploratory Analyses from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at the 8Th Congress of the European Academy of Neurology

Retrieved on: 
Monday, June 27, 2022
FDA, Multiple sclerosis, Patient, Publication, Disability, RMS, GLOBE, San Francisco, II, University of California, MAS, Food, European Academy of Neurology, SPA, University, Doctor of Philosophy, Pediatrics, NASDAQ, Congress, EAN, PDUFA, ARR, Stanford University, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TG, Therapy, Pharmaceutical industry, MD, Neurology, Neuroscience

The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries.

Key Points: 
  • The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries.
  • Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity.
  • We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
  • The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

SwanBio Presents Design of Innovative Natural History Study Aimed to Evolve Understanding of Adrenomyeloneuropathy and Inform Future Treatments

Retrieved on: 
Monday, June 27, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Genetics, FDA, Patient, Hereditary spastic paraplegia, Falls, AMN, ABCD1, Research, Tissue, HIV disease progression rates, Trial of the century, Incontinence, Man, AAV, Disease, Quality of life, Pain, Endpoint security, European Academy of Neurology, Mass, Sexual dysfunction, Clinical trial, Learning, Congress, Drug development, EAN, Primate, Safety, Intention, Mutation, Therapy, Pharmaceutical industry, Medical imaging, Medical device, Adrenoleukodystrophy, Myelopathy

CYGNET is the first AMN clinical study to feature wearables, which may help us identify sensitive outcomes related to clinically relevant changes early in men with AMN.

Key Points: 
  • CYGNET is the first AMN clinical study to feature wearables, which may help us identify sensitive outcomes related to clinically relevant changes early in men with AMN.
  • SwanBio anticipates recruiting approximately 80 patients for the CYGNET natural history study; as of early June, the study was over 40% enrolled across five different global sites.
  • Clinicians or patients interested in learning more about this study can review SwanBios CYGNET flyer or contact SwanBio at [email protected] .
  • SwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, inherited neurological conditions.

European Academy of Neurology (EAN 2022) – Braintale to Present Promising Results on Amyotrophic Lateral Sclerosis Biomarker Potential of Its Digital Platform

Retrieved on: 
Monday, June 27, 2022
Research, Hospitals, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Diagnosis, Death, Ageing, Patient, Amyotrophic lateral sclerosis, Neurological disorder, Research, MDR, HIV disease progression rates, Brain, Evaluation, Epidemiology, Biomarker, Eupales, European Medical Writers Association, Neuroscience, ALS, White matter, Respiration (physiology), Cramp, Decision-making, CSO, Poster, Motor neuron, Smart contract, Risk, European Academy of Neurology, Hospital, ISO, Solution, Degenerative disease, EAN, Physician, Congress, MRI, Neurodegeneration, Medical imaging, Medical device, Neurology

The Braintale platform includes AI-processed CE-marked digital solutions, deployed across two modules.

Key Points: 
  • The Braintale platform includes AI-processed CE-marked digital solutions, deployed across two modules.
  • ALS is characterized by a progressive and irreversible degeneration of motor neurons that allow the bodys movements to be controlled.
  • *( Epidemiology of amyotrophic lateral sclerosis: an update of... : Current Opinion in Neurology (lww.com) , What is ALS?
  • With noninvasive, sensitive and reliable measurements of white matter microstructure alterations, Braintale offers a digital biomarkers platform to support clinical decision-making.

EAN Congress 2022: COVID-19 positive patients at higher risk of developing neurodegenerative disorders, new study shows

Retrieved on: 
Friday, June 24, 2022
Department, Department of Neurology, Xuanwu hospital, Patient, New Brunswick neurological syndrome of unknown cause, Narcolepsy, Sex, Neurodegeneration, Lists of diseases, Urinary tract infection, COVID-19, Multiple sclerosis, Parkinson's disease, Stroke, Association, Rigshospitalet, Risk, European Academy of Neurology, Pneumonia, Guillain–Barré syndrome, Incidence, Myasthenia gravis, Congress, EAN, Intracranial hemorrhage, Alzheimer's disease, Pharmaceutical industry, Vaccine

VIENNA, June 24, 2022 /PRNewswire/ -- The study, which analysed the health records of over half of the Danish population, found that those who had tested positive for COVID-19 were at an increased risk of Alzheimer's disease, Parkinson's disease, and ischaemic stroke.

Key Points: 
  • While neuroinflammation may contribute to an accelerated development of neurodegenerative disorders, the authors highlighted implications of the scientific focus on long-term sequelae after COVID-19.
  • The study analysed Danish in- and outpatients between February 2020 and November 2021, as well as influenza patients from the corresponding pre-pandemic period.
  • The increased risk of most neurological diseases was, however, no higher in COVID-19 positive patients than in people who had been diagnosed with influenza or other respiratory illnesses.
  • COVID-19 patients did have a 1.7 times increased risk of ischaemic stroke in comparison to influenza and bacterial pneumonia in patients over 80 years of age.

EAN Congress 2022: COVID-19 positive patients at higher risk of developing neurodegenerative disorders, new study shows

Retrieved on: 
Friday, June 24, 2022
Department, Department of Neurology, Xuanwu hospital, Patient, New Brunswick neurological syndrome of unknown cause, Narcolepsy, Sex, Neurodegeneration, Lists of diseases, Urinary tract infection, COVID-19, Multiple sclerosis, Parkinson's disease, Stroke, Association, Rigshospitalet, Risk, European Academy of Neurology, Pneumonia, Guillain–Barré syndrome, Incidence, Myasthenia gravis, Congress, EAN, Intracranial hemorrhage, Alzheimer's disease, Pharmaceutical industry, Vaccine

VIENNA, June 25, 2022 /PRNewswire/ -- The study, which analysed the health records of over half of the Danish population, found that those who had tested positive for COVID-19 were at an increased risk of Alzheimer's disease, Parkinson's disease, and ischaemic stroke.

Key Points: 
  • COVID-19 positive outpatients are at an increased risk of neurodegenerative disorders compared with individuals who tested negative for the virus, a new study presented today at the 8th European Academy of Neurology (EAN) Congress has shown.
  • The study analysed Danish in- and outpatients between February 2020 and November 2021, as well as influenza patients from the corresponding pre-pandemic period.
  • The increased risk of most neurological diseases was, however, no higher in COVID-19 positive patients than in people who had been diagnosed with influenza or other respiratory illnesses.
  • COVID-19 patients did have a 1.7 times increased risk of ischaemic stroke in comparison to influenza and bacterial pneumonia in patients over 80 years of age.

New Analysis Finds UPLIZNA® (inebilizumab) Effective Among European Populations with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Friday, June 24, 2022
Health, Pharmaceutical, Loss of Sensation, Science, Patient, NMOSD, EC, Union, Aquaporin 4, B cell, All European Academies, Royal commission, European Academy of Neurology, Quality of life, Attack, NMO, CD19, Optic nerve, Astrocyte, Pain scale, Spinal cord, Woman, Autoimmunity, Safety, Risk, Instagram, Congress, Twitter, Forward-looking statement, LinkedIn, Experiment, Brain, Poster, Severe cognitive impairment, European Commission, Central nervous system, Neuromyelitis optica spectrum disorder, Autoantibody, Inflammation, Nasdaq, Cell, EMEA, Courage, Adult, Head, Paralysis, U.S. Securities and Exchange Commission, Spectrum disorder, EAN, Physician, Pharmaceutical industry, Medical device, Vaccine, Wood drying, EU, Facebook

These data are being presented during the 8th Congress of the European Academy of Neurology (EAN), June 25-28 in Vienna.

Key Points: 
  • These data are being presented during the 8th Congress of the European Academy of Neurology (EAN), June 25-28 in Vienna.
  • Fewer NMOSD-related hospitalisations were reported among those receiving UPLIZNA compared to those treated with placebo (mean, EU: 1.0 vs 2.0; non-EU: 1.0 vs 1.33).
  • NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes.
  • Baranello RJ, Avasarala, JR. Neuromyelitis optica spectrum disorders with and without aquaporin 4 antibody: Characterization, differential diagnosis, and recent advances.