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Rheumatoid Arthritis

FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …

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FDA Approves Sandoz’s Biosimilar Hyrimoz (adalimumab-adaz) for all Indications of Reference Medicine

Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years …

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Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …

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Bristol-Myers Squibb to Showcase Immunoscience Research and Biomarker-Guided Treatment Approaches at ACR/ARHP Annual Meeting

PRINCETON, N.J–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that 28 abstracts related to ORENCIA® (abatacept) and the Company’s immunoscience pipeline will be presented at the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, October 19-24, 2018, in Chicago. The abstracts accepted for presentation include clinical and …

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age …

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Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in Phase 3 Rheumatoid Arthritis Study

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that FINCH 2, a global, randomized, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its …

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Phase 3 Data of Amgen’s Infliximab Biosimilar Candidate Confirm Non-Inferiority

THOUSAND OAKS, Calif., June 27, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE®(infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary …

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Sandoz Presents New Long-Term and Switching Data for Biosimilars Zessly and Erelzi in Rheumatoid Arthritis

Holzkirchen, June 15, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly®(infliximab)[4],[5] and biosimilar Erelzi® (etanercept).[6],[7] Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi …

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Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI, FLIXABI and IMRALDI

INCHEON, Korea & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. and Biogen (Nasdaq:BIIB) today announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar) – which will be presented at the Annual European Congress of Rheumatology (EULAR 2018) …

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Celltrion Showcases Promising Preliminary Results for New Subcutaneous Formulation of CT-P13 in Rheumatoid Arthritis

AMSTERDAM–(BUSINESS WIRE)–New data presented at the Annual European Congress of Rheumatology (EULAR 2018) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with rheumatoid arthritis (RA) up to week 30. The …

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