Specialty Pharma Journal Specialty, Precision & Technology
Basel, December 6, 2018 – Novartis today announced additional analysis from the global Phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. In …
Tag Archives: novartis
December, 2018
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5 December
FDA Grants Priority Review to Novartis’ AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1
Basel, December 3, 2018 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], an investigational gene replacement therapy for the treatment of spinal muscular atrophy (SMA) Type 1. ZOLGENSMA is designed to address the …
November, 2018
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19 November
FDA Approves Novartis’ Promacta for first-line SAA and Grants Breakthrough Therapy Designation for Additional New Indication
Basel, November 16, 2018 – Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label for Promacta® (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST). Promacta, which is marketed as Revolade® in most countries …
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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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30 October
Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that it has entered into a non-exclusive clinical development agreement with Novartis (NYSE: NVS) to investigate one or more combination therapies for the treatment of non-alcoholic steatohepatitis (NASH). The companies will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational therapies, …
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19 October
Novartis to Pay $2.1 Billion for Acquisition of Cancer Drugmaker Endocyte
Basel, October 18, 2018 – Novartis today announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Under the terms of the agreement, Novartis would acquire all outstanding shares of Endocyte common stock for USD 24 …
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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 …
September, 2018
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28 September
FDA Approves Pediatric Dose of Sandoz’s Symjepi Injection
PRINCETON, N.J., Sept. 27, 2018 /PRNewswire/ — Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPI™ (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPI™ (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg …
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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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23 August
Novartis’ Investigational PI3K inhibitor Meets Primary Endpoint in Phase 3 Breast Cancer Trial
Basel, August 23, 2018 – Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with …