Sclerosis

EQS-News: Immunic Receives Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

Retrieved on: 
Wednesday, April 10, 2024
Biotechnology, Patent, Multiple sclerosis, Calcium, Into, Sclerosis, Pharmaceutical industry

The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.

Key Points: 
  • The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.
  • “Allowance of this key composition-of-matter patent, covering the specific polymorph of vidofludimus calcium, provides another important layer of proprietary intellectual property protection around our lead, late-stage asset,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
  • “A significant part of this patent will also cover the related method of producing material of vidofludimus calcium used in our studies.
  • On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.

Merz Enters Asset Purchase Agreement With a US-Based Biotech Company

Retrieved on: 
Tuesday, April 2, 2024
Science, Neurology, Biotechnology, Research, Pharmaceutical, Finance, Health, Professional Services, Growth, PD, Patient, Merz, Sale, Acquisition, Sclerosis, Parkinson's disease, DSM-IV codes, Therapy, Acorda Therapeutics, Physician, Pharmaceutical industry

Merz Therapeutics, a business of Frankfurt-based Merz Group, has entered into an Asset Purchase Agreement to acquire two commercial medicines from NASDAQ-listed Acorda Therapeutics.

Key Points: 
  • Merz Therapeutics, a business of Frankfurt-based Merz Group, has entered into an Asset Purchase Agreement to acquire two commercial medicines from NASDAQ-listed Acorda Therapeutics.
  • Closing of the transaction would significantly contribute to the accelerated growth strategy of Merz Therapeutics.
  • This investment would add significantly to Merz Therapeutics growth strategy and expand our portfolio in the field of movement disorders and neurodegeneration.
  • As a German-based but global company, we are very interested in innovative acquisitions, on a global scale," concludes Jörg Bergler.

The Multiple Sclerosis Association of America (MSAA) Selects SEQSTER to Accelerate Patient-Centricity & Innovation

Retrieved on: 
Saturday, March 23, 2024
Science, Neurology, Software, Research, Health, Data Management, Health Technology, Technology, MSIN, Acceleration, Learning, Multiple sclerosis, 1-Click, Dell Medical School, Sclerosis, MSAA, Doctor of Philosophy, MD, University, Implementation Science, Novartis, Population health, Multimedia, Medical director, Nursing

SEQSTER PDM Inc. (“ SEQSTER ”), the leading patient-centric healthcare technology company, has been selected by the Multiple Sclerosis Association of America (MSAA) for its patient-centricity, 1-Click Records™ and cutting-edge longitudinal health record.

Key Points: 
  • SEQSTER PDM Inc. (“ SEQSTER ”), the leading patient-centric healthcare technology company, has been selected by the Multiple Sclerosis Association of America (MSAA) for its patient-centricity, 1-Click Records™ and cutting-edge longitudinal health record.
  • SEQSTER unifies people living with multiple sclerosis (MS), researchers, and care centers nationwide.
  • View the full release here: https://www.businesswire.com/news/home/20240321509514/en/
    Multiple Sclerosis Association of America (MSAA) Selects SEQSTER to Accelerate Patient-Centricity & Innovation (Graphic: Business Wire)
    This announcement follows the creation of the Multiple Sclerosis Implementation Network™ (MSIN™), which MSAA launched in collaboration with Novartis Pharmaceuticals Corporation in May 2023.
  • "I am deeply honored and profoundly excited to witness the remarkable collaboration between MSAA, clinicians, academic researchers, industry partners, and SEQSTER for the Multiple Sclerosis Implementation Network.

Immunic Receives Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

Retrieved on: 
Wednesday, March 20, 2024
Biotechnology, Patent, Multiple sclerosis, Calcium, Into, Sclerosis, Pharmaceutical industry

NEW YORK, March 20, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to provide protection into 2039, unless extended further. The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.

Key Points: 
  • "Allowance of this key composition-of-matter patent, covering the specific polymorph of vidofludimus calcium, provides another important layer of proprietary intellectual property protection around our lead, late-stage asset," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
  • "A significant part of this patent will also cover the related method of producing material of vidofludimus calcium used in our studies.
  • Vidofludimus calcium is covered by several layers of granted patents in the United States, Europe and other jurisdictions around the world.
  • On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.

Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans

Retrieved on: 
Tuesday, March 5, 2024
Tonix Pharmaceuticals, Animal, Transplant, FC, Risk, Multiple sclerosis, Protein engineering, Thrombosis, Immunoglobulin G, Autoimmunity, Haematopoietic system, Hook effect, Half-life, Sclerosis, Kidney

CHATHAM, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the results of modeling key human pharmacokinetic (PK) properties for TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* from animal studies. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.

Key Points: 
  • TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.
  • “Preclinical studies in non-human primates have shown that TNX-1500 maintains the activity of first generation mAbs, with reduced risk of thrombotic complications.3-5 Today we are announcing that modeling studies from animal PK data3, predict that a half-life of approximately three weeks for TNX-1500 in humans6,7, which supports monthly dosing.
  • or biweekly s.c. dosing regimens.2 Based on its results in multiple sclerosis, Sanofi projects that frexalimab will exceed €5B per year in peak sales1.
  • TNX-1500 was designed to reduce binding to the Fc-receptor for IgG type 2a, or FcγR2a, which has been shown to play a role in the thrombosis associated with first-generation anti-CD40L mAbs, similar to frexalimab.

EMD Serono Presents New MAVENCLAD® Data Supporting Cognitive Function Benefits

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, Senior, Merck, Quality of life, Merck Serono, Treatment, Disease, Multiple sclerosis, System, Safety, EDSS, Health care, Bawskee 3.5, SDMT, Patient, Employment, Cladribine, Sclerosis, RMS, Tablet, Merck Group, MRI, Pharmaceutical industry

The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS.

Key Points: 
  • The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS.
  • Additionally, interim findings from year three of the MAGNIFY-MS extension trial underscore the continued efficacy and safety profile of MAVENCLAD, which is consistent with earlier safety data.
  • These data are being presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.
  • The post-hoc analysis from 270 patients showed a clinically meaningful benefit in cognitive processing speed in patients treated with MAVENCLAD.

Good News--MS Drugs Taken While Breastfeeding May Not Affect Child Development

Retrieved on: 
Tuesday, March 5, 2024
NMOSD, Social media, Hellwig, Nervous system, Alzheimer's disease, MD, Ofatumumab, Stroke, German, Pregnancy, Life, Risk, Annual general meeting, Multiple sclerosis, DSM-IV codes, AAN, Health, Migraine, Parkinson's disease, Hypoesthesia, Fatigue, Ruhr University Bochum, Mother, Paresthesia, Infant, Concussion, Spinal cord, Breast milk, Epilepsy, Sclerosis, Disease, Child, Rituximab, Natalizumab, Optic nerve, Brain, Demyelinating disease, Research, Immune system, American Academy, Birth control

MS is a disease in which the body's immune system attacks myelin, the fatty white substance that insulates and protects the nerves.

Key Points: 
  • MS is a disease in which the body's immune system attacks myelin, the fatty white substance that insulates and protects the nerves.
  • For the study, researchers used the German MS and Pregnancy Registry to identify 183 infants born to mothers taking monoclonal antibodies while breastfeeding.
  • The first exposures to the medications through breastfeeding ranged from the day a child was born to the ninth month of life.
  • After comparing infants exposed to the medications to infants not exposed, researchers found no differences in their health or development.

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

Retrieved on: 
Friday, March 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.

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

Retrieved on: 
Saturday, January 6, 2024
Urinary tract infection, Patient, Medical Subject Headings, Marketing, Agency, Jaw, INN, Interferon beta-1a, Immune system, Fever, Tears, ATC, Disability, Multiple sclerosis, Kidney, Hypertension, International, Blood, RRMS, Attack, Spinal cord, Disease, Headache, Language, Brain, Myocardial infarction, Eye, Heart, Inflammation, Thyroid, Stroke, Head, Angina, European Medicines Agency, Infection, Coagulopathy, Lymphocyte, HIV, Select, Central nervous system, Human, Safety, Anatomy, Checklist, Sclerosis, IIA, Optic nerve, Neck, Rash, CD52, Medical device

Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Date of authorisation: 12/09/2013, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Date of authorisation: 30/01/2014, Revision: 29, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Medical Subject Headings, Diarrhea, Marketing, INN, Risk, Immune system, Stomach, Interferon beta-1a, ATC, Pain, Multiple sclerosis, Capsule, International, RRMS, Spinal cord, Disease, PML, Ageing, Nausea, Language, Brain, Mouth, Eye, Inflammation, Flushing, European Medicines Agency, Food, Gene, Glatiramer acetate, Select, Central nervous system, Patient, Safety, Encephalitis, Anatomy, Sclerosis, Optic nerve, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Date of authorisation: 30/01/2014, Revision: 29, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Tecfidera, dimethyl fumarate, Date of authorisation: 30/01/2014, Revision: 29, Status: Authorised