Thymectomy

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

Retrieved on: 
Giovedì, Aprile 4, 2024
Vital capacity, MuSK protein, Glucocorticoid, NMPA, Hormone, GMG, Disease, Chinese, MRS, BCMA, Nervous system, Patient, SAN, Enzyme inhibitor, History, Female, Multiple myeloma, CRS, B cell, Biotechnology, IND, Phenotype, Investigational New Drug, QMG, Safety, Thymectomy, FDA, Food

The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.

Key Points: 
  • The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.
  • The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively.
  • No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period.
  • Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion.

Muscular Dystrophy Association Celebrates FDA Approval of UCB’s RYSTIGGO for the Treatment of Generalized Myasthenia Gravis

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Martedì, Giugno 27, 2023
Communication, US Food Sovereignty Alliance, Disease, MuSK protein, Doctor of Philosophy, Thymectomy, GMG, Efgartigimod alfa, Fc receptor, Antibody, Immunoglobulin G, Enzyme inhibitor, Ravulizumab, UCB, Patient, MG, Muscular Dystrophy Association, Acetylcholine receptor, Neonatal Fc receptor, MDA, FDA, Pharmaceutical industry, Vaccine, Eculizumab

New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Key Points: 
  • New York, June 27, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of RYSTIGGO (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
  • RYSTIGGO is the only FDA-approved treatment in adults for both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG, and will be administered as an injection for subcutaneous infusion.
  • Although treatment with RYSTIGGO will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.
  • “Rystiggo is a welcome addition to the targeted therapeutic options available for the treatment of generalized myasthenia gravis,” said Sharon Hesterlee, Ph.D., Chief Research Officer, MDA.

Muscular Dystrophy Association Celebrates FDA Approval of argenx’s Vyvgart Hytrulo Injection for Treatment of Generalized Myasthenia Gravis

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Mercoledì, Giugno 21, 2023
Communication, US Food Sovereignty Alliance, Disease, Travel, University, IV, Doctor of Philosophy, Public policy, Thymectomy, GMG, Myasthenia gravis, Quality of life, Research, Antibody, Enzyme inhibitor, MG, MD, UCSF, Patient, Muscular Dystrophy Association, Immunoglobulin G, Acetylcholine receptor, Hospital, Neonatal Fc receptor, MDA, FDA, Pharmaceutical industry, Eculizumab, Efgartigimod alfa

New York, June 20, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of subcutaneous (SC) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc),for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Key Points: 
  • New York, June 20, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of subcutaneous (SC) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc),for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
  • Vyvgart Hytrulo is the first FDA-approved SC injectable for gMG and will be made available and marketed in the United States by argenx.
  • The new SC formulation can now be administered as a single injection (1,008 mg fixed dose) at home or in a physician’s office.
  • Although treatment with Vyvgart will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.

RemeGen Receives Orphan Drug Designation from FDA for Telitacicept for the Treatment of Myasthenia Gravis

Retrieved on: 
Giovedì, Ottobre 13, 2022
SLE, News, MG, Cholinesterase, NMPA, Disease, B-cell activating factor, Immunoglobulin G, Laboratory, Lupus, Glucocorticoid, Degenerative disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Muscle weakness, Patient, Social conditions in Honduras, Research, ODD, IgG4-related ophthalmic disease, Myasthenia gravis, Food, Immune system, Trial of the century, Company, National Medical Products Administration, CEO, FC, Nature, GMG, Thymectomy, SHA, Plasmapheresis, Environment, Speech, Eye, TACI, FDA, Autoimmunity, Neutralizing antibody, Solution, Pharmaceutical industry, Vaccine

YANTAI, China, Oct. 12, 2022 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG).

Key Points: 
  • YANTAI, China, Oct. 12, 2022 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG).
  • Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease which causes patients to be prone to fluctuating muscle weakness.
  • At present, the most common treatment options to alleviate symptoms for MG include cholinesterase inhibitors, glucocorticoids, immunosuppressants, intravenous immunoglobulin, plasma exchange, anti-CD20 monoclonal antibodies (mAbs), and thymectomy.
  • "We're delighted that the FDA has granted ODD for the RemeGen created proprietary novel fusion protein Telitacicept," said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen.

MDA Celebrates FDA Approval of Alexion's Ultomiris for Treatment of gMG

Retrieved on: 
Sabato, Aprile 30, 2022
Diarrhea, Adult, US Food Sovereignty Alliance, ALS, Immune system, Cholinesterase, American Academy, LinkedIn, Hematology, MDA, Upper respiratory tract infection, Association, Neurology, Patient, Twitter, FDA, Muscular dystrophy, Neuromuscular junction, TikTok, Food, Acetylcholine receptor, Disease, Muscular Dystrophy Association, GMG, Multimedia, Thymectomy, Alexion, AstraZeneca, Drug development, View, Research, Autoimmune disease, Communication, Degenerative disease, Safety, Pharmaceutical industry, Vaccine, Dietary supplement, Facebook, C5, Eculizumab, Ravulizumab, Instagram

In Oct. 2017, eculizumab (marketed by Alexion as Soliris) became the first disease modifying drug approved by the FDA to treat gMG.

Key Points: 
  • In Oct. 2017, eculizumab (marketed by Alexion as Soliris) became the first disease modifying drug approved by the FDA to treat gMG.
  • Eculizumab was approved for adults living with the gMG subtype known as acetylcholine receptor antibody-positive (AChR ab+) gMG, which affects 80-90% of people with gMG.
  • "The approval of Ultomiris is an important step forward in treating gMG," said Dr. Sharon Hesterlee, Chief Research Officer for MDA.
  • Although treatment with Ultomiris will not cure gMG, it could lead to functional improvements that improve the daily life of individuals with gMG.

Survey Shows Impact of Myasthenia Gravis Specialists on Treatment Perspectives, Condition Knowledge

Retrieved on: 
Mercoledì, Giugno 2, 2021
Branches of biology, Organ systems, Autoimmune diseases, Anatomy, Myasthenia gravis, Myasthenia, Weakness, Neuromuscular junction, Thymectomy, Neuromuscular junction disease

The inaugural Myasthenia Gravis In America survey illuminates the perspectives and experiences of people living with myasthenia gravis.

Key Points: 
  • The inaugural Myasthenia Gravis In America survey illuminates the perspectives and experiences of people living with myasthenia gravis.
  • Myasthenia gravis (MG) is a rare neuromuscular condition in which antibodies destroy the communication between nerves and muscles; in its most common form, MG leads to fluctuating weakness among the voluntary muscles.
  • According to the Myasthenia Gravis Foundation of America, there are as many as 60,000 people living with the condition.
  • The Myasthenia Gravis In America survey, which fielded from Oct. 14, 2020 to Feb. 11, 2021, included responses from 600 people living with myasthenia gravis.

Insights on the Myasthenia Gravis Drugs Global Market to 2027 - Featuring Novartis International, Pfizer & Shire Among Others

Retrieved on: 
Venerdì, Aprile 9, 2021
Clinical medicine, Medical specialties, Myasthenia gravis, Thymectomy, Myasthenia

DUBLIN, April 9, 2021 /PRNewswire/ -- The "Myasthenia Gravis Drugs - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, April 9, 2021 /PRNewswire/ -- The "Myasthenia Gravis Drugs - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • The U.S. Market is Estimated at $372.1 Million, While China is Forecast to Grow at 8.2% CAGR
    The Myasthenia Gravis Drugs market in the U.S. is estimated at US$372.1 Million in the year 2020.
  • In the global Thymectomy segment, USA, Canada, Japan, China and Europe will drive the 10.8% CAGR estimated for this segment.
  • Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach US$260.7 Million by the year 2027.