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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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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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Lilly Submits New Drug Application for Lasmiditan to the FDA for Acute Treatment of Migraine

INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and …

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Amgen Presents Results Highlighting the Long-Term Safety and Efficacy of Repatha in the Longest Duration Study of a PCSK9 Inhibitor to Date

THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies. …

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Gilead Presents Data From Nonalcoholic Steatohepatitis Program for Advanced Fibrosis

SAN FRANCISCO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical development program for advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Data presented support the ongoing development of the company’s investigational compounds, evaluate the utility of noninvasive tests for the identification of patients with advanced fibrosis, …

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Bone Therapeutics Halts Phase 3 PREOB Study for Treatment of Hip Osteonecrosis

Gosselies, Belgium, 6 November 2018, 8pm CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces the conclusions of the Data and Safety Monitoring Board (DSMB) for the interim analysis of the Phase III osteonecrosis …

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Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab

CAMBRIDGE, Mass., Oct. 26, 2018 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that Biogen presented results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension (LTE) of …

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Biogen and Eisai Present Additional Data from Phase 2 Trial of Investigational Treatment for Early Alzheimer’s Disease

TOKYO and CAMBRIDGE, Mass., Oct. 25, 2018 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced that Eisai presented the latest data from the Phase II clinical study (Study 201) of BAN2401, …

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FDA Grants Priority Review to Incyte’s Ruxolitinib for Treatment of Patients with Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids. The FDA grants Priority Review …

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Vertex Data Presented at NACFC Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating Cystic Fibrosis

DENVER–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that eight scientific abstracts from the company’s portfolio of cystic fibrosis (CF) medicines are being presented at the 32nd North American Cystic Fibrosis Conference taking place October 18-20, 2018 in Denver. Key highlights include presentations of Phase 2 data evaluating clinical safety and efficacy …

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