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Autoimmune Disorders

Amgen Wins Enbrel US Patent Litigation, Delaying Sandoz’s Biosimilar Plan

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen’s favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La …

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FDA Approves Samsung Bioepis’ Hadlima, a Biosimilar Referencing Humira

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the …

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FDA Approves Pfizer’s Biosimilar, Ruxience (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2 “Biosimilars like RUXIENCE have …

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Takeda’s Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in its Phase 3 Crohn’s Disease Trial

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD) who achieved …

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Mallinckrodt and Silence Therapeutics Collaborate for Development of RNAi Therapeutics for Complement-Mediated Diseases

STAINES-UPON-THAMES, United Kingdom and LONDON, July 18, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, and Silence Therapeutics plc (LON: SLN), a leader in the discovery, development and delivery of novel RNA2interference (RNAi) therapeutics for the treatment of serious diseases, today announced a collaboration that will allow the companies to develop and commercialize RNAi drug targets …

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Phase 3 Study Showed that Genentech’s Rituxan is Superior to Standard of Care in Achieving Sustained Remission in Pemphigus Vulgaris

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive top line results from the Roche-sponsored Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). …

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Phase 3 Study of Savara’s Molgradex Fails to Meet its Primary Endpoint in Patients with Autoimmune Alveolar Pulmonary Proteinosis

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks …

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First-of-its-Kind Data Shows Efficacy and Safety of Novartis’ Cosentyx in All Key Manifestations of Psoriatic Arthritis

Basel, June 12, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, today announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary …

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Genentech’s Gazyva Met Both Primary and Key Secondary Endpoints in Phase 2 Lupus Nephritis Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in …

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Merck to Acquire Tilos Pharmaceuticals for up to $773 Million, Gaining Portfolio of Investigational Antibodies Modulating TGFβ

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. “At …

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