Specialty Pharma Journal Specialty, Precision & Technology
NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for …
Tag Archives: RA
December, 2018
November, 2018
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28 November
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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19 November
Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems
LONDON–(BUSINESS WIRE)–Celltrion Healthcare outlined their vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, US. Biosimilars offer healthcare providers and patients greater treatment choice and value, better access to treatments and improved patient outcomes. According to data provided by IMS …
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1 November
Sanofi and Denali Therapeutics Partner to Develop Treatments for Neurological and Inflammatory Diseases
PARIS, France – November 1, 2018 – Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases. The two lead molecules (DNL747 and DNL758) target a critical signaling protein known as the receptor-interacting serine/threonine-protein …
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1 November
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 …
October, 2018
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17 October
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 …
September, 2018
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13 September
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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12 September
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 …
June, 2018
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27 June
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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14 June
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) …