Autoimmune disease

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

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수요일, 3월 13, 2024

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Global IgG Mediated Autoimmune Diseases Biologic Drugs Research Report 2024: A Highly Competitive Market with Pharmaceutical and Biotechnology Firms Competing for the $197.75 Billion Market Share - ResearchAndMarkets.com

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화요일, 3월 12, 2024

The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.

Key Points: 
  • The Global IgG Mediated Autoimmune Diseases Biologic Drugs market showcased growth at a CAGR of 7.25% during 2019-2022.
  • The increasing incidence and prevalence of IgG mediated autoimmune diseases such as rheumatoid arthritis, lupus, and psoriasis are major drivers for the growth of biologic drugs.
  • The global market for IgG mediated autoimmune diseases biologic drugs is highly competitive, with numerous pharmaceutical companies and biotechnology firms competing for market share.
  • The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Antibody Source (Humanized, Fully Human, Chimeric, Other Antibody Sources)
    The report analyses the IgG Mediated Autoimmune Diseases Biologic Drugs Market By Indication (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Multiple Sclerosis and Other Indications).

Viatris Hosts R&D Event Focusing on its Collaboration with Idorsia, Phase 3 Assets Selatogrel and Cenerimod and Key Elements of its Pipeline

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수요일, 3월 27, 2024

The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline.

Key Points: 
  • The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline.
  • The collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience.
  • The Company will review key elements of the collaboration including how Viatris can make a difference in the delivery of these assets.
  • An archived version also will be available following the live event and can be accessed at the same location for a limited time.

JDRF Shines Light on Type 1 Diabetes During Autoimmune Awareness Month

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화요일, 3월 26, 2024

NEW YORK, March 26, 2024 /PRNewswire/ -- In recognition of Autoimmune Awareness Month, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, recognizes all those who live with T1D, an autoimmune condition that causes the pancreas to make very little insulin or none at all. T1D is one of nearly 100 autoimmune diseases that occur when the body's immune system mistakenly attacks another part of the body. While there are currently no cures for autoimmune diseases, screening options may be available, which can reduce the risk of life-threatening complications at diagnosis and provide people time to develop a plan in partnership with their healthcare team. JDRF continues advancing breakthroughs to find cures for T1D, including research that has the potential to impact other autoimmune diseases.

Key Points: 
  • Screening for type 1 diabetes can reduce the risk of life-threatening complications at diagnosis.
  • NEW YORK, March 26, 2024 /PRNewswire/ -- In recognition of Autoimmune Awareness Month, JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, recognizes all those who live with T1D, an autoimmune condition that causes the pancreas to make very little insulin or none at all.
  • JDRF continues advancing breakthroughs to find cures for T1D, including research that has the potential to impact other autoimmune diseases.
  • JDRF encourages those with T1D and other autoimmune diseases to share their stories and continue to build awareness of their conditions and opportunities for screening.

Research case series presents food as medicine as a potential treatment for lupus and other autoimmune diseases

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화요일, 3월 19, 2024

ST. LOUIS, March 19, 2024 /PRNewswire-PRWeb/ -- A new research case series published in Frontiers in Nutrition presents food as medicine as a potential treatment for autoimmune diseases, describing three patients with chronic autoimmune disease who showed remarkable improvement after following a predominantly raw dietary pattern high in cruciferous vegetables and omega 3 fatty acids.

Key Points: 
  • ST. LOUIS, March 19, 2024 /PRNewswire-PRWeb/ -- A new research case series published in Frontiers in Nutrition presents food as medicine as a potential treatment for autoimmune diseases, describing three patients with chronic autoimmune disease who showed remarkable improvement after following a predominantly raw dietary pattern high in cruciferous vegetables and omega 3 fatty acids.
  • All three women reported that nearly all their symptoms of both diseases resolved after just four weeks of making the dietary changes.
  • "My hope is that these cases generate greater recognition, making patients and clinicians aware of food as medicine as a treatment option for systemic lupus erythematosus and Sjögren's syndrome.
  • This case series also reflects the immediate need for more research into dietary changes as a potential treatment strategy for autoimmune disease."

Study shows improved hand function using Carbonhand

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수요일, 3월 13, 2024

STOCKHOLM, March 13, 2024 /PRNewswire/ -- Today, a study on Improved physical function using a power-enhancing glove in persons with Inclusion Body Myositis was presented at the Global Conference on Myositis in Pittsburgh, USA.

Key Points: 
  • STOCKHOLM, March 13, 2024 /PRNewswire/ -- Today, a study on Improved physical function using a power-enhancing glove in persons with Inclusion Body Myositis was presented at the Global Conference on Myositis in Pittsburgh, USA.
  • The preliminary results show increased hand function and improved physical function for people with impaired hand function during use of Carbonhand.
  • The study was open to people with idiopathic inflammatory myopathies who perceived hand weakness.
  • The study included 40 persons with IBM that had reduced grip strength (kg) (md;range) (3.75;1.3-10.7) and physical function (IBM-FRS 20;2-38, IBM-PRO 23;1-44).

Women Rising Presents Research Findings from Its National Survey, Autoimmunity and the "Good Girls" ™

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화요일, 3월 12, 2024

NEW YORK, March 12, 2024 /PRNewswire/ -- Women Rising, an 11x award-winning women's empowerment and media company founded by autoimmune-diagnosed, 15x award-winning documentary filmmaker, Sara Hirsh Bordo, is releasing findings from Autoimmunity and the "Good Girls" ™  the first-ever sociological survey exploring the intersection between empowerment and autoimmunity in American women. Defined as the immune system at war with itself by not being able to distinguish between the "good" and the "bad" cells and tissues, autoimmune diseases are afflicting millions.  According to the Autoimmune Association, there are over 100 autoimmune diseases on record, none with known cures, and women consistently receive 80% percent of the total diagnoses.

Key Points: 
  • "During a relapse of my Hashimoto's disease in 2019, I began researching my own health and empowerment origin stories, and patterns emerged," says Sara Hirsh Bordo, Women Rising founder.
  • "Many of us were raised as "good girls," conditioned to suppress and betray our own needs for the good of others.
  • I wanted to study empowerment, and the lack thereof, as a potential missing modality in women's health— in hopes of supporting other women like me."
  • In Autoimmunity and the "Good Girls" ™ out of total women screened, nearly a quarter of the 2,525 had been diagnosed with at least one autoimmune disease.

PolTREG receives CGMP certification to produce cell therapies at its state-of-the-art manufacturing site in Poland

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월요일, 3월 11, 2024

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 under a hospital exemption valid in Poland.

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 under a hospital exemption valid in Poland.
  • Its manufacturing facility is one of Europe’s largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines.
  • PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies from future partners.
  • “This certification is an important recognition of PolTREG’s leading capabilities in manufacturing cellular therapies, a highly sophisticated process that requires deep experience to master,” said Prof. Piotr Trzonkowski, Chief Executive Officer of PolTREG.

Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

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목요일, 3월 7, 2024

GAITHERSBURG, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2023, and recent corporate updates.

Key Points: 
  • Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024.
  • Announced Positive Long-Term Follow-Up Data from Phase 2a Study of Descartes-08 in Patients with MG.
  • In January 2024, Cartesian announced that the FDA cleared its IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T product candidate.
  • General and administrative expenses were $40.6 million for the year ended December 31, 2023, compared to $23.9 million for the year ended December 31, 2022.

argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting

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목요일, 3월 7, 2024

“We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

Key Points: 
  • “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
  • Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies.
  • Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.