Neurodegeneration

Quanterix Expands Laboratory Developed Test Menu with Launch of Neurofilament Light Chain Test

Retrieved on: 
Monday, January 9, 2023
Health, Neurology, Other Science, Research, Science, Biotechnology, Simoa, Multiple sclerosis, RUO, Blood, Neurodegeneration, CSF, CLIA, Ageing, RRMS, SLAC National Accelerator Laboratory, MS, Laboratory developed test, AFL, HIV, Amyotrophic lateral sclerosis, Corporation, Microangiopathy, LDT, FDA, Risk, Neurology, Plasma, TBI, ISO 15189, Protein, Diagnosis, Central nervous system, CAR, Therapy, Patient, HIV/AIDS, Research, ISO, Stroke, Serum, Nerve, Concussion, Traumatic brain injury, Clinical trial, Cerebrospinal fluid, ALS, Medical device, Pharmaceutical industry, Medical imaging, Parkinsonism

NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.

Key Points: 
  • NfL is a well-studied biomarker for neuro-axonal injury with wide applicability to different neurological disorders.
  • Any disorder or injuring force resulting in neuronal damage can lead to the release of NfL into the interstitial fluid and cerebrospinal fluid (CSF).
  • A fraction of these proteins diffuses into the blood, where concentrations are typically 50- to 100-fold lower than in CSF and difficult to measure with conventional immunoassay technologies.
  • “Assessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging.

FSD Pharma Inc Incorporates New Subsidiary to Capitalize on Drug Development Incentives in Australia

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Monday, January 9, 2023
Mental Health, Health, Research, Pharmaceutical, Science, Biotechnology, Government, Mental health, Multiple sclerosis, Royal College of Physicians and Surgeons of Canada, Faculty, Associate, CAMH, Drug development, London Olympics, FSD, Neurodegeneration, University Hospitals Plymouth NHS Trust, Neurology, University, Liaquat National Hospital, University of Oxford, Science, Nicotine, DRS, CSE, Neuroscience, University of Bristol, Liver transplantation, Special interest group, Medicine, Scientist, Interest group, European Association for the Study of the Liver, University of Melbourne Faculty of Science, Royal college, Senior, Bachelor of Medicine, Bachelor of Surgery, British, University of Cambridge, FRA, University College London, National Hospital for Neurology and Neurosurgery, Fine chemical, Medical device, Pharmaceutical industry, Philosophy, Neurosurgery, Pharmacology

“We are excited about the incorporation of FSD Pharma Australia, where we have an excellent opportunity to advance our pipeline,” said Mr. Zeeshan Saeed, President of FSD Pharma.

Key Points: 
  • “We are excited about the incorporation of FSD Pharma Australia, where we have an excellent opportunity to advance our pipeline,” said Mr. Zeeshan Saeed, President of FSD Pharma.
  • “Australia is a hotbed for clinical stage biotech companies, and our drug development programs will be able to take advantage of facilities offered by various government incentives in Australia,” added Mr. Saeed.
  • Chataway, Dhanda and Lê have agreed to join our international panel to contribute to our current and new programs,” said Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals, a wholly owned subsidiary of FSD Pharma.
  • Dr. Chataway received his Bachelor of Medicine & Surgery from Oxford University, and Doctor of Philosophy from Cambridge University.

Myrtelle Announces Positive Interim Data in Phase 1/2 Clinical Trial of Its Proprietary Investigational Gene Therapy rAAV-Olig001-ASPA in Canavan Disease

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Monday, January 9, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, White matter, CSF, Clinical trial, MRI, Associate, Gross, N-Acetylaspartic acid, Food, Cerebrospinal fluid, Wright, European Medicines Agency, MD, Boonshoft School of Medicine, Inc., ASPA, CD, Metabolism, FIH, NAA, Patient, Myrtelle Canavan, Pediatrics, Classification, US Foods, Mutation, Canavan disease, Magnetic resonance imaging, Rita Raave, Orphan drug, Hospital, Fast Track, Neurodegeneration, Pharmaceutical industry, Medical imaging

Early data from the study, being conducted at Dayton Children’s Hospital (Dayton, Ohio), at three months following gene therapy treatment have shown encouraging results to date.

Key Points: 
  • Early data from the study, being conducted at Dayton Children’s Hospital (Dayton, Ohio), at three months following gene therapy treatment have shown encouraging results to date.
  • The observed improvements following gene therapy are in contrast to the continuous clinical decline expected for untreated CD patients.
  • The first three patients treated with the gene therapy in cohort one are now at least 18 months post therapy.
  • “The early results to date in patients treated in Myrtelle’s Phase 1/2 clinical trial are encouraging.

Life Molecular Imaging and Jubilant Radiopharma announce Neuraceq® availability in Southeast United States

Retrieved on: 
Tuesday, January 10, 2023
Partnership, Drug development, Government budget balance, Research, LMI, Brain, Alzheimer's disease, Dementia, Disease, Patient, SPECT, Physician, PET, Jubilant, Neurodegeneration, Medical imaging

BOSTON, Jan. 10, 2023 /PRNewswire-PRWeb/ -- Life Molecular Imaging (LMI) and Jubilant Radiopharma announce today that both companies have entered into a strategic partnership and licensing agreement providing Jubilant Radiopharma with rights to manufacture and distribute Neuraceq® in the Southeast Region of United States. Jubilant Radiopharma will manufacture Neuraceq® at their PET cyclotron facility which has an adjoining SPECT radiopharmacy in Norcross, GA. The first doses will be available from January 18th, 2023.

Key Points: 
  • BOSTON, Jan. 10, 2023 /PRNewswire-PRWeb/ -- Life Molecular Imaging (LMI) and Jubilant Radiopharma announce today that both companies have entered into a strategic partnership and licensing agreement providing Jubilant Radiopharma with rights to manufacture and distribute Neuraceq® in the Southeast Region of United States.
  • Jubilant Radiopharma will manufacture Neuraceq® at their PET cyclotron facility which has an adjoining SPECT radiopharmacy in Norcross, GA.
  • "With the addition of Jubilant's Norcross Radiopharmacy to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain.
  • "It is a great pleasure to have signed this important manufacturing and distribution agreement with Life Molecular Imaging" – declares Renato Leite, President at Jubilant Radiopharmacies.

Going Back to the Basics: Greenfilled Offers Simple Yet Comprehensive Nutritional Support

Retrieved on: 
Tuesday, January 10, 2023
Oxidative stress, Mental health, Sustainability, SOD, Research, Phytoplankton, Rheumatoid arthritis, Inflammation, Health, Superoxide dismutase, Philosophy, Enforcement actions against açaí berry supplement manufacturers, Ginkgo biloba, Quality of life, Mind, Neurodegeneration, Dietary supplement

FORT LAUDERDALE, Fla., Jan. 10, 2023 /PRNewswire/ -- Greenfilled is a supplement brand focused on one goal above all others: to enhance health through superoxide dismutase (SOD). The powerful enzyme provides bodily support on a cellular level by acting as an essential antioxidant defense against oxidative stress in the body. This means SOD has many proven and potential therapeutic benefits, including in the management of inflammatory diseases, rheumatoid arthritis, and neurodegenerative diseases.

Key Points: 
  • The powerful enzyme provides bodily support on a cellular level by acting as an essential antioxidant defense against oxidative stress in the body.
  • This means SOD has many proven and potential therapeutic benefits, including in the management of inflammatory diseases, rheumatoid arthritis, and neurodegenerative diseases.
  • It can help with an individual's physical and mental functionality in the here and now while also providing long-term health and anti-aging properties."
  • This is the philosophy behind Greenfilled, sweet and simple product selection.

BrainStorm Cell Therapeutics Partners with NEALS, The ALS Association, and I AM ALS to Provide Public Access to Biospecimens from NurOwn's Phase 3 ALS Study

Retrieved on: 
Tuesday, January 10, 2023
Housing, CSF, Brainstorm, Fluid mechanics, Serum, Cerebrospinal fluid, Drug development, Research, Organization, Biomarker, ALS, Patient, ALS Association, Biology, Therapy, Senior, MPH, Collection, Neurodegeneration, Pharmaceutical industry, MD

NEW YORK, Jan. 10, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that BCLI will donate biospecimens from NurOwn's placebo-controlled Phase 3 ALS trial to the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) biorepository for use by the research community. The specimens are being submitted to the biorepository in connection with a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS, to support biomarker research.

Key Points: 
  • The specimens are being submitted to the biorepository in connection with a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS, to support biomarker research.
  • The specimens submitted to the NEALS biorepository include serum and cerebrospinal fluid (CSF) samples collected from trial participants treated with placebo.
  • "We are pleased to have supported the NurOwn biomarkers study with I AM ALS, and are encouraged the scientific community will now have access to these biospecimens.
  • This will allow for independent replication and validation of the critical biomarkers data," said Kuldip Dave, Ph.D., Senior Vice President of Research for The ALS Association

Premier Research and CENTOGENE Launch Strategic Partnership to Accelerate and De-Risk Rare Disease Clinical Development

Retrieved on: 
Monday, January 9, 2023
Epigenomics, Partnership, Drug discovery, Metabolomics, CLIA, Disease, Research, Patient, Degenerative disease, Physician, Therapy, Epilepsy Phenome/Genome Project, CAP, History, CNTG, ISO, Neurodegeneration, Pharmaceutical industry, Proteomics

MORRISVILLE, N.C., and CAMBRIDGE, Mass., ROSTOCK, Germany, and BERLIN, Jan. 9, 2023 /PRNewswire/ -- Premier Research, whose mission is to help the most innovative biotech and medtech companies take their best ideas from concept to commercialization, and Centogene N.V. [Nasdaq: CNTG], the essential life science partner for data-driven answers in rare and neurodegenerative diseases, have announced a strategic partnership to provide end-to-end support in rare disease clinical trials. The collaboration aims to improve patient identification, stratification, recruitment, and enrollment, thereby increasing the likelihood of study success.

Key Points: 
  • Inherently small patient populations coupled with the complexities of disease diagnosis create significant challenges in enrolling rare disease clinical trial participants.
  • Combining Premier Research's deep expertise in rare disease product development with advanced insights generated from the CENTOGENE Biodatabank and multiomic reference laboratories will support the faster identification of eligible patients.
  • "The CENTOGENE Biodatabank and multiomic-based services will enhance how we design and recruit for rare disease clinical trials," Premier Research Senior Vice President, Project Delivery Angi Robinson said.
  • With extensive experience based on more than 240 rare disease studies in the past five years, Premier Research is constantly investing in new approaches that meet the complexities of rare disease research.

Pharnext strengthens its ties with Néovacs to secure the next steps in its development

Retrieved on: 
Sunday, January 22, 2023
Communication, Regulatory News Service, CET, Medtech, Research, CFO, Biotechnology, Patient, Degenerative disease, Confidentiality, Investment, FDA, Therapy, Sciences Po, EMA, Verney-Carron, Marketing, Neurodegeneration, Hugo, Security (finance), Pharmaceutical industry, Health insurance, Management, Euronext

Under the terms of the agreement, Néovacs could become a reference shareholder of Pharnext as of January 1, 2024.

Key Points: 
  • Under the terms of the agreement, Néovacs could become a reference shareholder of Pharnext as of January 1, 2024.
  • This new financing agreement is a partial or total complement to the OCEANE-BSA financing granted by Global Tech Opportunities 13 ("GTO 13").
  • However, Néovacs, through the trust managing its financing contract with Pharnext, has agreed to subscribe to the €1 million tranche scheduled for late December.
  • It was unbelievable that the Company would find itself in difficulty and that is why Néovacs decided to support it.

Pharnext strengthens its Senior Leadership Team with the appointment of Scott Johnson as VP, Head of Quality

Retrieved on: 
Sunday, January 22, 2023
General counsel, Warner Chilcott, CMC, Regulatory News Service, Master of Pharmacy, CET, United States Department of the Navy, Pharmacovigilance, MD, Johnson & Johnson, Pfizer, Good laboratory practice, Good manufacturing practice, Capsule, Eastern University, Sri Lanka, NDA, BA, Good clinical laboratory practice, Patient, Organization, Regulatory affairs, SLT, Therapy, Charcot–Marie–Tooth disease, Cellectis, Eastern University, Master of Science, Quality assurance, Tablet, Scott, Bachelor of Science, Gan, Doctor of Philosophy, Neurodegeneration, Hugo, Management, Pharmaceutical industry, Medical device, Sanofi, Quality

Pharnext strengthens its Senior Leadership Team with the appointment of Scott Johnson as VP, Head of Quality

Key Points: 
  • Pharnext strengthens its Senior Leadership Team with the appointment of Scott Johnson as VP, Head of Quality
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • Pharnext strengthens its Senior Leadership Team with the appointment of Scott Johnson as VP, Head of Quality
    PARIS, France, January 4th, 2023, 08:30 am CET – Pharnext SA (FR001400BV89 - ALPHA) (the “Company”), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces the appointment of Scott Johnson as VP, Head of Quality.
  • Prior to Oyster, Scott served as Director, Quality Assurance at Lupin Pharmaceuticals where he had overall responsibility for quality and compliance.
  • Hugo Brugière, Chairman and Chief Executive Officer of Pharnext, commented: “I look forward to working with Scott and am delighted to welcome him to the Pharnext Senior Leadership Team.

Annexon Highlights Strategic Focus to Advance Four Flagship Complement Programs through Late-Stage Development and Progress Across Three Therapeutic Franchises

Retrieved on: 
Sunday, January 8, 2023
Well, Severe cognitive impairment, SAD, Autoimmune disease, Complement component 1q, Autoimmune hemolytic anemia, Disease, Growth, LN, Plasma, Medicine, Neurodegeneration, Investment, The First Half of My Life, GA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brain, HIV disease progression rates, Lupus nephritis, HD, Nephritis, AFL, Physician, Eye, Pivotal trial, FDA, Autoimmunity, Geographic atrophy, GBS, Anemia, Food, ALS, Continuous Progress Mathematics, Time-invariant system, Therapy, Webcast, Nerve, Hemolysis, CAD, MAD, Multifocal motor neuropathy, Cold agglutinin disease, Nerve Damage, Patient, Ophthalmology, MMN, Conference, Pharmaceutical industry, Waiha, Amyotrophic lateral sclerosis

BRISBANE, Calif., Jan. 08, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today reported progress across its broad portfolio of complement therapies and outlined its focus on four flagship programs to support its advancement to a late-stage biopharmaceutical company developing first-in-class treatments for complement-mediated diseases of the body, brain and eye.

Key Points: 
  • Annexon has prioritized resources and execution of late-stage development of its four flagship programs: Guillain-Barré syndrome (GBS), Huntington’s disease (HD), geographic atrophy (GA) and its first-in-kind oral small molecule, ANX1502.
  • Our mission is to free the body, brain and eye from diseases driven by the classical complement cascade,” said Douglas Love, president and CEO of Annexon.
  • Following an assessment of the market opportunity in wAIHA and a range of additional autoimmune indications, Annexon has determined not to advance development in wAIHA.
  • A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.