RRMS

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Retrieved on: 
Thursday, March 21, 2024
Research, Medical Devices, Neurology, FDA, Genetics, Clinical Trials, Biotechnology, General Health, Health, Science, Vagus nerve, Device, CDRH, Patient, Regulatory affairs, TAP, Remyelination, Clinical trial, Safety, Set, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval.
  • In October 2023, the FDA expanded the program to include neurological and physical medicine devices.
  • SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions.

SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Retrieved on: 
Wednesday, March 13, 2024
Medical Devices, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Vagus nerve, Neurology, Brain, Rheumatoid arthritis, Communication, Multiple sclerosis, Patient, Myelin, Remyelination, Neck, Axon, Clinical trial, Johns Hopkins University, Pain, Nerve, Fatigue, Set, FDA, Visual impairment, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • Breakthrough Device Designation will enable interactive communication and priority regulatory review with the FDA, and support reimbursement and patient access upon FDA approval of SetPoint’s technology.
  • This Breakthrough Device Designation is based on evidence demonstrating that SetPoint's treatment has the potential to reduce demyelination and promote remyelination.
  • In 2020, the FDA also granted Breakthrough Device Designation to SetPoint's device for the treatment of rheumatoid arthritis (RA).

OM1 to Present Research on Multiple Sclerosis at ACTRIMS Forum 2024

Retrieved on: 
Tuesday, February 27, 2024
Technology, Health, Neurology, Artificial Intelligence, Other Science, Other Technology, Research, Managed Care, Networks, General Health, Health Technology, Science, Data Management, Cardiology, Cloud, AI, SPMS, RWD, Conditional sentence, Multiple sclerosis research, Multiple sclerosis, Data, EDSS, RRMS, Disability, Patient, OM1, Poster, Mental health, Medical imaging

The poster will focus on the use of an AI based estimation model used to help characterize disease progression in multiple sclerosis (MS) subtypes using real-world data (RWD).

Key Points: 
  • The poster will focus on the use of an AI based estimation model used to help characterize disease progression in multiple sclerosis (MS) subtypes using real-world data (RWD).
  • WHEN: The presentation will be held on the first day of ACTRIMS Forum 2024 on Thursday, February 29 between 6:00 – 7:30 pm ET.
  • WHY: To effectively monitor disease progression in patients with MS, the measurement of disability is an important component.
  • For insights specific to OM1’s work with multiple sclerosis, including the company’s PremiOM MS dataset, visit the website page here .

Sandoz launches first and only biosimilar for multiple sclerosis, Tyruko® (natalizumab), in Germany

Retrieved on: 
Wednesday, January 31, 2024
Multiple sclerosis, DMTS, Natalizumab, RRMS, Medicine, Patient, Nerve, Endocrinology, Neurology, Generic drug

53 SIX Swiss Exchange Listing Rules

Key Points: 
  • 53 SIX Swiss Exchange Listing Rules
    Basel, January 31, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Tyruko® (natalizumab) in Germany from February 1.
  • Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat RRMS.
  • Rebecca Guntern, President Europe, Sandoz, said: “Early treatment with disease-modifying therapies can have a significant impact on people living with multiple sclerosis and their potential future disabilities.
  • Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.

PolTREG CEO Trzonkowski co-authors peer-reviewed article showing scientific progress in T-reg autoimmune therapy

Retrieved on: 
Tuesday, January 30, 2024
Partnership, WSA, Medical school, Inflammation, Holocene, PTG, Cell, Multiple sclerosis, Immune system, Trial of the century, International Centre, Clinical trial, Therapy, Patient, Institute of technology, White, Frontiers, PPMS, RRMS, Disease, Science, University, Health, ALS, Autoimmune disease, University of Birmingham, Warsaw Stock Exchange, Pharmaceutical industry

PolTREG was the first company in the world to administer T-reg therapies to patients and the first to start receiving revenues from its lead product.

Key Points: 
  • PolTREG was the first company in the world to administer T-reg therapies to patients and the first to start receiving revenues from its lead product.
  • So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland, where the company is completing its own state-of-the-art manufacturing facilities.
  • When found in the body, Treg cells are polyclonal, meaning they can react to a number of different antigenic triggers.
  • PolTREG (Gdańsk, Poland; WSA:PTG) is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs).

PolTREG receives US Patent Office Notice of Allowance for Treg cell therapy to treat Type-1 Diabetes

Retrieved on: 
Tuesday, January 16, 2024
WSA, Patient, Research, Medical school, Multiple sclerosis, Partnership, Element, Autoimmune disease, Graft-versus-host disease, PTG, Immune system, Cell, PPMS, Hospital, Therapy, Inflammation, RRMS, Patent, White, Warsaw Stock Exchange, Trial of the century, Pharmaceutical industry

The US allowance constitutes an important addition to the intellectual property portfolio covering PolTREG’s autoimmune therapies.

Key Points: 
  • The US allowance constitutes an important addition to the intellectual property portfolio covering PolTREG’s autoimmune therapies.
  • Many of PolTREG’s patent submissions are primary in the field, given that its team performed the first-in-human trials with Treg cell therapies in graft-versus-host disease in 2007-2009.
  • Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready to start Phase 2/3 clinical testing, upon partnership.
  • PolTREG also is developing engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, all of which are in the preclinical stage.

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

Human medicines European public assessment report (EPAR): Dimethyl fumarate Accord, dimethyl fumarate, Date of authorisation: 15/02/2023, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Multiple sclerosis, ATC, Justice, International, RRMS, Ageing, Language, Civil service commission, Select, Patient, Anatomy, Commission, Sclerosis, Accord, IIA, Judgement, Petrochemical

Overview

Key Points: 
  • Overview
    This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works Polpharma, Cases C-438/21 P to C-440/21 P.
    Dimethyl fumarate Accord : EPAR - Medicine overview
    Product information
    Dimethyl fumarate Accord : EPAR - Product information
    13/12/2023
    This medicine’s product information is available in all official EU languages.
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Accord : EPAR - All Authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Accord
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Multiple Sclerosis
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Teva, Multiple sclerosis, ATC, Justice, International, RRMS, Ageing, Language, Civil service commission, Select, Patient, Anatomy, Commission, Sclerosis, IIA, Judgement

Select 'available languages' to access the language you need.

Key Points: 
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Teva: EPAR - All authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Teva
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Multiple Sclerosis
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Assessment history
    This page was last updated on