JAMA Neurology

Catalyst Pharmaceuticals Announces Publication of Santhera Pharmaceutical’s VISION-DMD Vamorolone (AGAMREE®) Study Results in the Peer-Reviewed Journal Neurology

Retrieved on: 
Wednesday, February 21, 2024
Vamorolone, Catalyst Pharmaceuticals, NSAA, Safety, Prednisone, DMD, Growth, Duchenne muscular dystrophy, Neurology, Biomarker, BMI, Patient, LSM, JAMA Neurology, Pharmaceutical industry

Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.

Key Points: 
  • Catalyst holds the exclusive rights to commercialize AGAMREE® (vamorolone) in North America.
  • Based on the published study, Santhera has reported that the results of the VISION-DMD study support the long-term efficacy and safety profile of vamorolone and conclude that vamorolone was generally well tolerated, consistent with the 24-week study findings, as published previously in JAMA Neurology [2].
  • This study [VISION-DMD] was conducted to determine the efficacy and safety of vamorolone over 48 weeks and to study crossover participants (prednisone to vamorolone; placebo to vamorolone).
  • Improvements of motor outcomes seen with 6 mg/kg/d of vamorolone at 24 weeks of treatment were maintained to 48 weeks of treatment.

Neurocode Launches Groundbreaking pTau217 Blood Test for Alzheimer's Disease Clinical Diagnosis

Retrieved on: 
Monday, March 4, 2024
Collection, Doctor of Philosophy, Research, MD, Blood, Pathology, Cerebrospinal fluid, Neurology, AUC, LDT, Laboratory developed test, Diagnosis, Simoa, Autopsy, Biomarker, Gold, Health, Patient, Radiation exposure, CSF, DSM-IV codes, Disease, PET, JAMA Neurology, Brain, Medical imaging

Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.

Key Points: 
  • Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.
  • Neurocode's new blood test is as accurate as brain imaging or CSF testing for diagnosing Alzheimer's, but is faster, more accessible, less expensive, and less invasive.
  • Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility.
  • Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site.

Alamar Biosciences and ALZpath, Inc. Announce Strategic Supply Agreement for pTau217 Antibody to Advance Alzheimer's Disease Research

Retrieved on: 
Thursday, February 29, 2024
Alzheimer's disease, Doctor of Philosophy, Dementia, Cerebrospinal fluid, Neurology, Neurodegenerative disease, Entrepreneurship, Biomarker, CNS, Proteomics, Disease, Plasma, Brain, Research, JAMA Neurology, Partnership

This collaboration marks a significant milestone in the advancement of novel tools for neurodegenerative disease research.

Key Points: 
  • This collaboration marks a significant milestone in the advancement of novel tools for neurodegenerative disease research.
  • The focal point of this partnership is the ALZpath pTau217 (phosphorylated tau at position 217) antibody, a crucial tool in the investigation of Alzheimer's disease and various other neurodegenerative disorders.
  • The ALZpath pTau217 antibody provides researchers with a highly sensitive and specific tool for the detection and analysis of pathological changes associated with Alzheimer's disease.
  • "We are excited to collaborate with ALZpath to provide this ultra-sensitive pTau217 assay," said Dr. Yuling Luo, Founder, Chairman & CEO of Alamar Biosciences.

Alamar Biosciences and ALZpath, Inc. Announce Strategic Supply Agreement for pTau217 Antibody to Advance Alzheimer's Disease Research

Retrieved on: 
Thursday, February 29, 2024
Alzheimer's disease, Doctor of Philosophy, Dementia, Cerebrospinal fluid, Neurology, Neurodegenerative disease, Entrepreneurship, Biomarker, CNS, Proteomics, Disease, Plasma, Brain, Research, JAMA Neurology, Partnership

This collaboration marks a significant milestone in the advancement of novel tools for neurodegenerative disease research.

Key Points: 
  • This collaboration marks a significant milestone in the advancement of novel tools for neurodegenerative disease research.
  • The focal point of this partnership is the ALZpath pTau217 (phosphorylated tau at position 217) antibody, a crucial tool in the investigation of Alzheimer's disease and various other neurodegenerative disorders.
  • The ALZpath pTau217 antibody provides researchers with a highly sensitive and specific tool for the detection and analysis of pathological changes associated with Alzheimer's disease.
  • "We are excited to collaborate with ALZpath to provide this ultra-sensitive pTau217 assay," said Dr. Yuling Luo, Founder, Chairman & CEO of Alamar Biosciences.

Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology

Retrieved on: 
Wednesday, February 14, 2024
Vamorolone, NSAA, Safety, Prednisone, DMD, Growth, Duchenne muscular dystrophy, Neurology, European, Biomarker, BMI, Patient, Disease, LSM, JAMA Neurology, Pharmaceutical industry

“Vamorolone is a dissociative corticosteroid that selectively binds to the glucocorticoid receptor and has shown similar efficacy and reduced safety concerns in comparison with prednisone in Duchenne muscular dystrophy (DMD) [3].

Key Points: 
  • “Vamorolone is a dissociative corticosteroid that selectively binds to the glucocorticoid receptor and has shown similar efficacy and reduced safety concerns in comparison with prednisone in Duchenne muscular dystrophy (DMD) [3].
  • This study [VISION-DMD] was conducted to determine the efficacy and safety of vamorolone over 48 weeks and to study crossover participants (prednisone to vamorolone; placebo to vamorolone).
  • There was an increase in BMI after 24 weeks of treatment that then stabilized for both vamorolone groups.
  • Improvements of motor outcomes seen with 6 mg/kg/d of vamorolone at 24 weeks of treatment were maintained to 48 weeks of treatment.

Awaken Hope, Embrace Healing: The Multiple Sclerosis and Neuroimmune Summit 2.0

Retrieved on: 
Friday, February 9, 2024
Knowledge, Hope, Education, Lupus, American College, Alzheimer's disease, Multiple sclerosis, Disability, Dementia, Disease, Exercise, Neurology, Empowerment, Health, Medicine, Internal medicine, Cognition, Movement, JAMA Neurology, Interview, FACN, Diet, Rheumatoid arthritis, Patient, Journal, Yoga, Functional medicine

CARLSBAD, Calif., Feb. 9, 2024 /PRNewswire/ -- DrTalks, a pioneering platform dedicated to advancing health, wellness, and medicine knowledge, is proud to announce Multiple Sclerosis and Neuroimmune Summit 2.0. This groundbreaking virtual event serves as an important platform for people grappling with multiple sclerosis and other neuroimmune conditions, offering a beacon of hope and a wealth of knowledge. Set to take place from August 20 to 26, 2024, this summit offers free online access to everyone interested in the latest breakthroughs in holistic and natural treatments for neuroimmune conditions.

Key Points: 
  • The Multiple Sclerosis and Neuroimmune Summit 2.0 is a premier virtual event that provides hope, knowledge, and support for people with multiple sclerosis and other neuroimmune conditions like lupus and rheumatoid arthritis.
  • CARLSBAD, Calif., Feb. 9, 2024 /PRNewswire/ -- DrTalks , a pioneering platform dedicated to advancing health, wellness, and medicine knowledge, is proud to announce Multiple Sclerosis and Neuroimmune Summit 2.0 .
  • This groundbreaking virtual event serves as an important platform for people grappling with multiple sclerosis and other neuroimmune conditions, offering a beacon of hope and a wealth of knowledge.
  • Dr. Wahls brings to the summit a unique perspective on neuroimmune conditions having been diagnosed with multiple sclerosis.

Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for the Indication of Amyotrophic Lateral Sclerosis

Retrieved on: 
Friday, January 26, 2024
Principal, ALS, Research, University of Tokushima, Biomedical sciences, Patient, Safety, Respiratory failure, Ministry, Neurodegenerative disease, Paralysis, Disease, MHLW, JAMA Neurology, Agonal respiration, Death, Eisai, Medication, PDMA, Muscle atrophy, NDA, Pharmaceutical industry

TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.

Key Points: 
  • TOKYO, Jan 26, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.
  • In May 2022, ultrahigh-dose mecobalamin received orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW).
  • The results of JETALS were published in the peer-reviewed journal JAMA Neurology.
  • ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction.

Xenon Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
Research, MADRS, Ageing, MDD, DBP, DSM-IV codes, Icahn School of Medicine at Mount Sinai, Neurocrine, Neurocrine Biosciences, JAMA Neurology, OLE, MPC, Mount Sinai, SCN8A, Webcast, Seizure, FOS, Safety, Epilepsy, Generalized tonic–clonic seizure, Patient, Grammatical mood, Pharmaceutical industry, Cryptocurrency, Xenon

VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024.
  • Other income for the quarter ended September 30, 2023 was $7.1 million, compared to $0.4 million for the same period in 2022.
  • Xenon will host a conference call and webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss its third quarter 2023 results.

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, November 6, 2023
Research, Mental Health, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Behavioral neuroscience, Attention, Headache, Incidence, CMAI, Food, Mini–Mental State Examination, DSM-IV codes, Brexpiprazole, OPDC, MD, Psychiatry, Food and Drug Administration Amendments Act of 2007, Deficit spending, Verbal aggression, Dementia, Multimedia, Medicine, Interview, Pneumonia, Somnolence, Lundbeck, Locomotion, Commercialization, JAMA Neurology, Cachexia, Screaming, Caregiver, Passive-aggressive behavior, Aggression, Saint Louis University School of Medicine, MMSE, Heart, Ōtsuka, Akathisia, Contra body movement, Agitation, Medication, Tearing, Anxiety, IPA, Patient, Diagnosis, Disease, Restless, Pharmaceutical industry, Nursing, Birth control

REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.
  • Participants also required a diagnosis that met The International Psychogeriatric Association’s (IPA) provisional definition of agitation in patients with cognitive impairment or dementia.
  • “Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them.
  • The trial had high rates of patients completing the trial: 86.8% of the brexpiprazole group and 88.9% of the placebo group.

Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b “X-TOLE” Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology

Retrieved on: 
Monday, October 9, 2023
Xenon, Food, JAMA Neurology, AES, Female, Death, American Epilepsy Society, Safety, Generalized tonic–clonic seizure, White, Epilepsy, SD, Neurology, Clinical trial, ASMS, IQR, Seizure, FOS, Patient, Pharmaceutical industry

VANCOUVER, British Columbia, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy.

Key Points: 
  • VANCOUVER, British Columbia, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy.
  • Importantly, the efficacy and safety findings of this clinical trial supported the further clinical development in epilepsy of XEN1101, which is currently being evaluated in Phase 3 clinical trials in patients with focal onset seizures (FOS) and primary generalized tonic-clonic seizures.
  • Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We are pleased to report that the peer-reviewed results from our Phase 2b X-TOLE study of XEN1101 in adults with focal epilepsy have been published in the prestigious JAMA Neurology journal.
  • The article entitled “Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy A Phase 2b Randomized Clinical Trial” was posted today on the JAMA Neurology website .