Optic neuritis

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

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星期五, 三月 1, 2024
Chorioretinitis, Natural history, Caregiver, New Drug Application, Ankylosing spondylitis, Optic neuritis, Education, FDA, Food, Adnexa, Shanda, Uveitis, Eye, Adrenocorticotropic hormone, Multiple sclerosis, Condylar resorption, Safety, Rheumatoid arthritis, Patient, Sclerosis, Disease, Keratitis, MRCP, Insurance, Pharmaceutical industry

DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as "SelfJect"), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3

Key Points: 
  • "We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions.
  • Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients.
  • Acthar Gel will continue to be available as an injection with a vial and syringe.
  • Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis.

The MOG Project, Pediatric Neurologist Secure CDC Approval to Adopt ICD-10 Code for Rare Disease MOGAD

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星期一, 十月 2, 2023
Insurance, Optic neuritis, General assembly, Disease, United Nations, Glycoprotein, CHLA, Neuroimmunology, ICD, Lou Ruvo Center for Brain Health, Knowledge Organization (journal), United Nations General Assembly, Centers for Disease Control and Prevention, Research, Brain, Children's Hospital, Multiple sclerosis, CDC, MOGAD, MD, Patient, Physician, Children's Hospital Los Angeles, Immune system, Optic nerve, Stockholm Environment Institute US Center, Transverse myelitis, Diagnosis, Knowledge, Neuromyelitis optica spectrum disorder, Barrow Neurological Institute, International Classification of Diseases, Video game–related health problems, FDA, Acute disseminated encephalomyelitis, WHO, World Health Organization, Medical device

OLNEY, Md., Oct. 2, 2023 /PRNewswire-PRWeb/ -- The MOG Project, a nonprofit organization committed to supporting the research and treatment of Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD) announced that its Executive Director Julia Lefelar, with support from The MOG Project Executive Board and Children's Hospital Los Angeles (CHLA) Pediatric Neurologist Jonathan Santoro, MD, secured approval to have the US Centers for Disease Control and Prevention (CDC) create an ICD-10 code for MOGAD. As of October 1, 2023, an official code for MOGAD is included in the 10th edition of the International Classification of Diseases (ICD) and Related Health Problems, which is relied upon by physicians and insurance providers to classify diagnoses and advise treatment.

Key Points: 
  • Without a CDC code, MOGAD patients had previously been grouped in with patients with similar diseases like neuromyelitis optica spectrum disorder, optic neuritis, acute disseminated encephalomyelitis, transverse myelitis and even multiple sclerosis.
  • "For the MOGAD community, this CDC code is more than a win for better health outcomes and fewer insurance delays, it gives our rare disease an identity and legitimizes it."
  • "The addition of a MOGAD specific ICD-10 code allows patients to better access the therapies that they need to treat their disease," said Santoro.
  • "Further, it allows for disease monitoring across the country, which will increase knowledge and research on this rare neuroimmunology disorder."

Globally Recognized Expert in Rare Neurologic Diseases, Dr. Michael Levy, Joins Trethera Scientific Advisory Board

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星期二, 九月 5, 2023
Demyelinating disease, DSM-IV codes, Optic neuritis, Central nervous system, University, Johns Hopkins Hospital, Myelin, Spinal cord, Cancer, Coronavirus Scientific Advisory Board, American Academy, Brain, Inflammation, Multiple sclerosis, Doctor of Philosophy, Associate, MS, Harvard Medical School, Nerve, CNS demyelinating autoimmune diseases, Patient, Division, Optic nerve, ADEM, Baylor College of Medicine, Hospital, Massachusetts General Hospital, American Academy of Neurology, Acute disseminated encephalomyelitis, Peripheral nervous system, Pharmaceutical industry, Philosophy, MD, Neurology

Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.

Key Points: 
  • Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.
  • When the myelin sheath is damaged, nerve impulses slow or even stop, causing neurological problems.
  • “We are honored to have Dr. Levy join our advisory board,” said Dr. Ken Schultz, Chairman and CEO of Trethera.
  • “He is a leading authority on rare neurologic autoimmune diseases and has expertise in both early and late-stage clinical trials.

A&W Canada Celebrates 15th Annual Burgers to Beat MS Day in Support of MS Canada on August 17

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星期一, 七月 17, 2023
Learning, Optic neuritis, Partnership, Central nervous system, A&W, Life, Spinal cord, T. J. Brodie, Shock, A&W Restaurants, Research, Brain, Multiple sclerosis, Sensation, Movement, MS, Toronto Maple Leafs, Fatigue, Pandemic, Diagnosis, Paratriathlon, Family, A&W (Canada), Fast food, Perfume, Pharmaceutical industry

VANCOUVER, BC, July 17, 2023 /CNW/ - Time to get your burger fix for a good cause, Canada, because A&W's annual Burgers to Beat MS Day is returning for its 15th year.

Key Points: 
  • VANCOUVER, BC, July 17, 2023 /CNW/ - Time to get your burger fix for a good cause, Canada, because A&W's annual Burgers to Beat MS Day is returning for its 15th year.
  • On August 17, A&W will donate $2 from every Teen Burger sold across the country to MS Canada to directly and positively impact Canadians living with multiple sclerosis (MS).
  • Donations to MS Canada through Burgers to Beat MS can be made starting today.
  • The partnership between A&W Canada and MS Canada began in 2008 and its first pilot in Saskatchewan raised more than $40,000.

Trethera Receives Grant from National Institute of Allergy and Infectious Diseases for the Advancement of TRE-515 in Lupus

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星期二, 六月 27, 2023
Transfer, Optic neuritis, Lupus, Flare, STTR, Cancer, End organ damage, Research, Brain, SLE, Biomarker, Investigational New Drug, Patient, Disease, Diagnosis, Mortality, NIAID, UCLA, National Institute of Allergy and Infectious Diseases, IND, NIH, Infection, Autoimmunity, Pharmaceutical industry

The grant will fund Investigational New Drug (IND) enabling activities using TRE-515 to treat systemic lupus erythematosus (SLE), a chronic autoimmune disease with significant morbidity and mortality.

Key Points: 
  • The grant will fund Investigational New Drug (IND) enabling activities using TRE-515 to treat systemic lupus erythematosus (SLE), a chronic autoimmune disease with significant morbidity and mortality.
  • Trethera’s lead asset, TRE-515, is a first-in-class deoxycytidine kinase (dCK) inhibitor.
  • "The potential TRE-515 has to treat a broad spectrum of diseases creates a pipeline in a product that reduces overall development risk," said Dr. Ken Schultz, principal investigator and Trethera CEO.
  • “We are grateful that the NIH also recognizes this, providing $4.2M in overall grant funding since September for optic neuritis, solid tumors, and now lupus.

UPLIZNA® (inebilizumab-cdon) Pivotal Trial Publication Integrating MRI and Biomarker Evaluation Shows Accuracy and Uniformity of Attack Diagnoses for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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星期一, 六月 12, 2023
Other Health, Research, General Health, Pharmaceutical, Optical, Genetics, Clinical Trials, Science, Biotechnology, Neurology, FDA, Health, Optic neuritis, Multiple Sclerosis Journal, Myelitis, Central nervous system, Attack, University, Glial fibrillary acidic protein, Serum, AC, Multiple sclerosis, University of Virginia School of Medicine, MRI, Virginia School for Girls, Risk, Neuromyelitis optica spectrum disorder, Neuro, Horizon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry, Medical device, Medical imaging, NMOSD

Properly defining NMOSD attacks is essential to inform treatment decisions, yet there are no universally accepted criteria for accurate and objective diagnosis of NMOSD attacks.

Key Points: 
  • Properly defining NMOSD attacks is essential to inform treatment decisions, yet there are no universally accepted criteria for accurate and objective diagnosis of NMOSD attacks.
  • The N-MOmentum pivotal trial, which demonstrated UPLIZNA reduced the risk of attacks associated with the disease, introduced a new approach for attack analysis.
  • Attacks were evaluated by an adjudication committee (AC, comprised of two neurologists and one neuro-ophthalmologist).
  • MRI and sGFAP biomarker findings provided additional specificity in the attack adjudication process.

Find Therapeutics welcomes Dr. Jack Antel to its clinical advisory board

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星期一, 五月 1, 2023
Sclerosis, Optic neuritis, Multiple Sclerosis Journal, Cleveland Clinic, Specialist, University, CAB, National Multiple Sclerosis Society, Clinical trial, KNEEMO Initial Training Network, American Academy, Research, University of Ottawa Heart Institute, Department of Neurology, Xuanwu hospital, Multiple sclerosis, MS, Teaching hospital, Multiple Sclerosis Society, Neuro-ophthalmology, Patient, Montreal Neurological Institute and Hospital, University of Genoa, McGill University Health Centre, Soft tissue injury, McGill University, ISCB Senior Scientist Award, Ottawa Hospital Research Institute, Neurosurgery, American Academy of Neurology, Therapy, International Society, Pharmaceutical industry, Management, Medical device, Neurology, Biostatistics

MONTREAL, May 1, 2023 /PRNewswire/ - Find Therapeutics Inc., a biopharmaceutical company focused on the development of innovative therapies for autoimmune diseases, today announced the appointment of Dr. Jack Antel to its Clinical Advisory Board (CAB).

Key Points: 
  • MONTREAL, May 1, 2023 /PRNewswire/ - Find Therapeutics Inc., a biopharmaceutical company focused on the development of innovative therapies for autoimmune diseases, today announced the appointment of Dr. Jack Antel to its Clinical Advisory Board (CAB).
  • Dr. Antel joins a CAB with considerable expertise in neuro-ophthalmology whose members have decades of clinical practice with optic neuritis patients as well as clinical trial expertise and peer-reviewed publications in this condition.
  • Dr. Antel is an internationally acclaimed clinical neurologist and thought leader who coordinates the multiple sclerosis research and treatment program at the Montreal Neurological Institute.
  • "We are honored and delighted to welcome Dr. Antel to our Clinical Advisory Board.

New Analysis of MRI Findings Show UPLIZNA® (inebilizumab-cdon) Reduced the Formation of Asymptomatic Optic Nerve Lesions in People With Neuromyelitis Optica Spectrum Disorder (NMOSD)

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星期二, 三月 14, 2023
Research, Neurology, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Optical, Science, MAS, ANVISA, NMO, NMOSD, Prognosis, Regulation of tobacco by the U.S. Food and Drug Administration, Risk, MRI, OLP, Patient, RCP, Optic nerve, European Commission, Spinal cord, Brazilian Health Regulatory Agency, Optic neuritis, Food, University, Civil service commission, Medical imaging

This new post-hoc analysis based on MRI imaging provides a deeper understanding of the treatment effect on subclinical lesions.

Key Points: 
  • This new post-hoc analysis based on MRI imaging provides a deeper understanding of the treatment effect on subclinical lesions.
  • The MRI findings showed that a high proportion of participants experienced subclinical optic nerve findings without new symptoms at the end of the RCP.
  • Importantly, while the total subclinical findings in the optic nerve were not reduced during the RCP, the number of clinical optic neuritis attacks was significantly reduced during this time period.
  • Moreover, the formation of these subclinical findings was reduced with repeated UPLIZNA treatment over the course of the OLP.

Optic Nerve Disorder Treatment Market to Reach USD 5.3 Billion, Globally, by 2031 at 4.5% CAGR: Allied Market Research

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星期一, 二月 27, 2023
Online, Optic nerve, Hospital, PDF, Pharmacy, Table, Online and offline, Optic neuritis, Risk, Ponesimod, Investment, Distribution, Growth, Government, COVID-19, Ozanimod, Prevalence, Pharmaceutical industry, Glaucoma, Others, Indication

PORTLAND, Ore., Feb. 27, 2023 /PRNewswire/ -- Allied Market Research published a report, titled, "Optic Nerve Disorder Treatment Market by Treatment Type (Steroidal Therapy, Immunomodulators Therapy, Others Treatment Type), by Indication (Optic Neuritis, Glaucoma, Optic Nerve Atrophy, Others), by Distribution Channel (Hospital Pharmacies, Drug Stores, Retail Pharmacies, Online Providers): Global Opportunity Analysis and Industry Forecast, 2021-2031." According to the report, the global optic nerve disorder treatment industry generated $3,372.46 million in 2021, and is estimated to reach $5,247.82 million by 2031, witnessing a CAGR of 4.5% from 2022 to 2031. The report offers a detailed analysis of changing market trends, top segments, key investment pockets, value chains, regional landscapes, and competitive scenarios.

Key Points: 
  • Increase in prevalence of optic nerve disorder treatment, growth in geriatric population and increase in technological advancement drive the growth of the global optic nerve disorder treatment market.
  • PORTLAND, Ore., Feb. 27, 2023 /PRNewswire/ -- Allied Market Research published a report, titled, " Optic Nerve Disorder Treatment Market by Treatment Type (Steroidal Therapy, Immunomodulators Therapy, Others Treatment Type), by Indication (Optic Neuritis, Glaucoma, Optic Nerve Atrophy, Others), by Distribution Channel (Hospital Pharmacies, Drug Stores, Retail Pharmacies, Online Providers): Global Opportunity Analysis and Industry Forecast, 2021-2031."
  • According to the report, the global optic nerve disorder treatment industry generated $3,372.46 million in 2021, and is estimated to reach $5,247.82 million by 2031, witnessing a CAGR of 4.5% from 2022 to 2031.
  • Impact of Covid-19 on Optic Nerve Disorder Treatment Market:
    Decrease in the demand for optic nerve treatment due to the risk of Covid-19 infection had a negative impact on the global optic nerve disorder treatment market, especially during the lockdown period.

Trethera Announces Poster Presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Meeting

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星期二, 一月 24, 2023
Treatment, Visual impairment, Great America Committee, Research, MS, Cancer, Multiple sclerosis, CD4, University of California, Los Angeles, University, Patient, DCK, Degenerative disease, Brain, Optic neuritis, Optic nerve, Medical imaging

LOS ANGELES, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces an upcoming poster presentation at the 8th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

Key Points: 
  • LOS ANGELES, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces an upcoming poster presentation at the 8th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
  • Dr. Peter M. Clark, of the University of California Los Angeles, will present preclinical research highlighting the use of Trethera’s deoxycytidine kinase (dCK) inhibitor, TRE-515, that suggests a functional role for deoxyribonucleoside salvage and dCK in multiple sclerosis (MS) mouse models.
  • Figure 1: PET scans showing mouse brain before (left) and after (right) MS induction (brain encircled in a dashed white line).
  • Targeting dCK with first-in-class inhibitor TRE-515 is shown to block symptoms across multiple MS mouse models by specifically limiting activated B and CD4 T cell proliferation.