Specialty Pharma Journal Specialty, Precision & Technology
DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing …
Tag Archives: multiple sclerosis
December, 2018
November, 2018
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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 …
October, 2018
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11 October
Recent Survey Reveals that Multiple Sclerosis Patients Want More Information on Brain Atrophy
SUMMIT, N.J.–(BUSINESS WIRE)–A new survey examines the topic of brain volume loss, known as brain atrophy, in people with multiple sclerosis. The survey findings, presented at ECTRIMS 2018, suggest that there is a high level of interest in better understanding how brain atrophy may impact disease progression. Sixty-three percent of …
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11 October
Teva Presents 25-Year Safety Data from Longest Continuous Trial of Copaxone for Treatment of Relapsing Forms of Multiple Sclerosis
JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE®(glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined …
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8 October
FDA Accepts Novartis’ NDA for Investigational Siponimod for the Treatment of Secondary Progressive Multiple Sclerosis
Basel, October 08, 2018 – Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in …
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3 October
Accelerated Cure Project Collaborates with EMD Serono to Advance Patient-Focused Drug Development in Multiple Sclerosis
WALTHAM, Mass., Oct. 2, 2018 /PRNewswire/ — Accelerated Cure Project (ACP) for Multiple Sclerosis (MS) today announced it has entered into a ground-breaking collaboration with EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, to capture and integrate the perspectives of people affected by …
September, 2018
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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 …
August, 2018
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30 August
MediciNova Announces the Publication of Results of the Phase 2b Trial of Ibudilast in Progressive MS
LA JOLLA, Calif., Aug. 29, 2018 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the New England Journal of Medicine has published results of the SPRINT-MS Phase 2b …
June, 2018
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14 June
Genentech Announces New Ocrevus Data on Long-Term Disability Benefits in Primary Progressive Multiple Sclerosis
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS® (ocrelizumab) data will be presented at the 4th Congress of the European Academy of Neurology (EAN) from June 16-19 in Lisbon, Portugal. The new Phase III data analyses show OCREVUS may …
May, 2018
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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 …