Tag Archives: AS

November, 2018

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 …
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24 October
Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet

CHICAGO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR …
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9 August
FDA Grants Prometic’s Rare Pediatric Disease Designation for its Alström Syndrome Drug

LAVAL, QC, Aug. 7, 2018 /PRNewswire/ – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic”) today announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to its small molecule drug candidate, PBI-4050, for the treatment of Alström syndrome (AS). In addition to …
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28 June
Lilly’s Taltz Met Primary and Major Secondary Endpoints in Late-Stage Ankylosing Spondylitis Trial

INDIANAPOLIS, June 28, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first …
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20 October
Agilis Presents Data from its Gene Therapy Program for Angelman Syndrome

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Agilis Biotherapeutics, Inc. (Agilis), a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), announced today two presentations on its gene therapy program for Angelman syndrome (AS). A poster presentation entitled, “The A-BOM: Collaborating to identify patient-centered biomarkers and outcome …
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4 November
Agilis Biotherapeutics’ Investigational Angelman Syndrome Drug Granted Orphan Drug Status

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Agilis Biotherapeutics, LLC (Agilis), a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AGIL-AS, the Company’s gene therapy product candidate being developed for …
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