Tag Archives: relapsing multiple sclerosis

September, 2018

13 September
Novartis Announces Publication of Landmark Study Demonstrating Significant Benefit of Gilenya in Children and Adolescents with MS

Basel, September 12, 2018 – Novartis today announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya® (fingolimod) PARADIGMS study, the first-ever controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of MS (RMS). Children and adolescents with MS experience …
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14 May
FDA Approves Novartis’ Gilenya for Pediatric Patients with Relapsing Multiple Sclerosis

Basel, May 11, 2018 – Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients[2]. This …
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4 October
FDA Approves Mylan’s Generic Version of Teva’s Multiple Sclerosis Drug Copaxone

HERTFORDSHIRE, England, and PITTSBURGH, Oct. 3, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 40 …
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22 May
Celgene Ozanimod Demonstrates Positive Results in Second Late-Stage Trial in Relapsing Multiple Sclerosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that its phase III RADIANCE trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly …
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17 February
Celgene’s Multiple Sclerosis Pill Meets Primary Endpoint in First Late-Stage Clinical Trial

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to …
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22 December
Genentech’s Ocrevus Demonstrates Positive Results in Phase III Multiple Sclorosis Study

December 21, 2016 05:00 PM Eastern Standard Time SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple …
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1 July
Genentech’s Ocrelizumab Granted Priority Review as First Potential Therapy for PPMS

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) accepted for review the company’s Biologics License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple …
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8 June
Biogen’s Multiple Sclerosis Drug Misses Main Goal in its Phase 2 Study

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Today Biogen (NASDAQ: BIIB) reported top-line results from the Phase 2 SYNERGY study evaluating opicinumab (anti-LINGO-1), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis (RMS). In the study, opicinumab missed the primary endpoint, a multicomponent …
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