Despite the beneficial therapeutic effects of IVIg in inflammatory diseases, consistent therapeutic efficacy and the challenges of administration remain major limitations for patients and physicians using IVIg. Home > Pipeline > Clinical Trials Nipocalimab, an anti-FcRn antibody, in adult patients with generalized myasthenia gravis (gMG) Learn more.

In clinical settings, therapeutic plasmapheresis and immunoabsorption are often used to remove autoantibodies and other blood components contributing to disease. Nipocalimab, an anti-FcRn antibody, in women who are currently pregnant and have had a prior pregnancy with hemolytic disease of the fetus and newborn (HDFN). When off-label may mean off-target: How would doctors and insurers navigate demand for a new, narrow Alzheimer’s drug? H ealth care giant Johnson & Johnson said Wednesday that it is acquiring Momenta Pharmaceuticals, gaining access to a promising experimental treatment for autoimmune diseases. NEW BRUNSWICK, N.J., Aug. 19, 2020 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion. Health care giant Johnson & Johnson said Wednesday that it is acquiring Momenta Pharmaceuticals, gaining access to a promising experimental treatment for autoimmune diseases. Ezekiel Emanuel on vaccines, Trump’s Covid-19 treatment, and what went wrong on the U.S. response, Pharmalittle: J&J pauses Covid-19 vaccine trial; Moderna exec has earned $50 million from stock sales during pandemic, The most comprehensive industry coverage from a powerhouse team of reporters, Daily newsletters to brief you on the most important industry news of the day, Weekly opportunities to engage with our reporters and leading industry experts in live video conversations, Premium access to subscriber-only networking events around the country, The most trusted and well-connected newsroom in the health care industry. Learn more. STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. M230 is being developed in collaboration with CSL. The presence of pathogenic antibodies which facilitate tissue damage and organ dysfunction is a hallmark of immune-mediated diseases. Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The rational engineering of therapeutics that broadly antagonize FcγRs has been hampered by a limited understanding of the molecular determinants directing FcγR activation. Through the experiences, connections and resources shared here, we hope to give a voice to people living with MG and a place to jump in, explore the future, and iMaGine the Possibilities. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. The all-cash deal values the company at $6.5 billion.

Blocking FcRn reduces circulating pathogenic IgG through inhibition of IgG recycling and inhibits the transport of pathogenic IgG across the placenta in pregnancy. NIH paused Eli Lilly Covid-19 antibody trial because of…, NIH paused Eli Lilly Covid-19 antibody trial because of safety concerns, Fauci: Trump’s rapid recovery from Covid-19, while welcome, ‘amplifies’…, Fauci: Trump’s rapid recovery from Covid-19, while welcome, ‘amplifies’ public misunderstanding of disease, Johnson & Johnson Covid-19 vaccine study paused due to…, Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant, AstraZeneca loses first-of-its-kind lawsuit filed by Dutch insurer over…, AstraZeneca loses first-of-its-kind lawsuit filed by Dutch insurer over patent maneuver, Covid-19 clinical trial pauses ‘show the system is working’, Pharmalittle: NIH pauses Lilly Covid-19 drug trial; Trump team…, Pharmalittle: NIH pauses Lilly Covid-19 drug trial; Trump team tries to rebrand FDA’s emergency use, Reporting from the frontiers of health and medicine. Using proprietary antibody engineering technology, we have developed a fully human IgG1 monoclonal antibody that targets the IgG-binding site of FcRn, called nipocalimab (M281). Momenta is being acquired for $52.50 per share, or a 73% premium to Tuesday’s closing price.

The multiple Fc domains of ICs aggregate Fcγ receptors (FcγRs), triggering cellular activation processes that play critical roles in inflammation and tissue damage. Momenta Pharmaceuticals Announces Positive Topline Data from Interim Analysis of Phase 2 Vivacity-MG Study of Nipocalimab (M281) in Generalized Myasthenia Gravis (gMG) 05/07/2020 Momenta Pharmaceuticals Reports First Quarter 2020 Financial and Operating Results IVIg has been used for more than 30 years for the treatment of a variety of acute and chronic autoimmune and systemic inflammatory diseases. The global market for IVIg exceeds $8 billion, with the majority of products currently approved being for use in treatment of autoimmune disease. Antigen-autoantibody immune complexes (ICs) are a common pathogenic hallmark of many autoimmune diseases. Momenta Pharmaceuticals is a biotechnology company with a validated, innovative scientific platform. Shares of Momenta Pharmaceuticals (NASDAQ:MNTA) continued to climb after the biotech updated investors on its pipeline progress and what to expect this year. iMaGineMyMG.com was created specifically with and for people living with MG. Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Momenta also provides J&J an early-stage pipeline of several novel drugs as well as a biosimilar platform. Using proprietary sialylation technology, a method to add sialic acid to protein, we have developed hsIgG, a robust, controlled sialylation process to generate tetra-Fc-sialylated immunoglobulins with consistent enhanced anti-inflammatory activity. The identification of the important anti-inflammatory role of Fc-sialylation has presented us an opportunity to create more potent immunoglobulin therapies. These challenges have stimulated our desire to generate therapeutic alternatives that could leverage the broad mechanisms of action of IVIg while improving therapeutic consistency and potency.

The clinical benefit of these procedures suggest that the removal of autoantibodies may lead to improvement of symptoms in some autoimmune indications. Removal of autoantibodies may be addressable by targeting FcRn, the neonatal Fc receptor which recycles immunoglobulin G (IgG) into circulation maintaining the long half-life of IgG. In clinical settings, therapeutic plasmapheresis and immunoabsorption are often used to remove autoantibodies and other blood components contributing to disease. Nipocalimab, an anti-FcRn antibody, in women who are currently pregnant and have had a prior pregnancy with hemolytic disease of the fetus and newborn (HDFN). Nipocalimab, an anti-FcRn antibody, in adult patients with warm autoimmune hemolytic anemia (wAIHA). NEW BRUNSWICK, N.J., August 19, 2020 – Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion. We focus on discovering and developing novel therapeutics to treat rare immune-mediated diseases, while advancing our late stage biosimilar portfolio. Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free! Nipocalimab, an anti … Inside Momenta; Benefits; Search Openings ; Clinical Trials. Intravenous immunoglobulin (IVIg) is a therapeutic blood product prepared from the pooled plasma of 3,000 to 60,000 healthy donors per batch. In doing so, we have the potential to change the future for the patients who inspire us. We have the potential to defy impossible by targeting rare, immune-mediated disease areas with significant unmet need in which the current standard of care falls short. Nipocalimab, an anti-FcRn antibody, in adult patients with generalized myasthenia gravis (gMG). The presence of pathogenic antibodies which facilitate tissue damage and organ dysfunction is a hallmark of immune-mediated diseases. Hyper-sialylated IgG M254, an innovative therapeutic candidate, being evaluated in healthy volunteers and patients with immune thrombocytopenia purpura (ITP). Through the engineering and characterization of Fc structures, we were able to derive novel insights into FcγR modulation and have generated a unique recombinant trivalent human IgG1 Fc multimer, referred to as M230, with optimal physiochemical and biological properties.



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