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CSL Behring’s Kcentra Shows Superiority to Plasma in Late-Stage Study

Results from CSL Behring’s late-stage study showing Kcentra’s superiority to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, warfarin) therapy in adult patients needing an urgent surgery or invasive procedure were published in The Lancet. CSL’s Kcentra is the first and …

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Imbruvica Demonstrates Promising Results in Phase III Trial in Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Janssen Biotech, Inc. and partner Pharmacyclics, Inc. announced that an Independent Data Monitoring Committee determined that its late-stage trial, evaluating Imbruvica in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) met its primary endpoint. According to the companies, during a pre-planned interim analysis of the Phase III …

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Biosimilars 20/20: A Market Analysis of the Growth and Implications of Biosimilars Over the Next Five Years

TAMPA, FL, March 16, 2015 — The biosimilars event of the year – Biosimilars 20/20 – is scheduled for June 3-4, 2015 at The Hub in Philadelphia, PA. The event promises to provide an in-depth look into the future of the biosimilars market and address challenges of implementation. Biosimilars 20/20 …

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FDNA to Launch Online Forum for the Genetics Expert Community

Pioneer in computer-aided dysmorphology analysis, FDNA, announced that it will launch an online forum for the genetics expert community for undiagnosed and challenging cases. The company said that it will unveil the “Unknown Forum” at the Annual Clinical Genetics Meeting ACMG 2015 in Salt Lake City, UT on March 26, …

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CMS Expands Telemedicine Services Coverage through New ACO Model

The Centers for Medicare & Medicaid Services (CMS) is launching a Next Generation Accountable Care Organization (ACO) Model of payment and care delivery, an initiative that will extend coverage for telemedicine services to millions of Medicare beneficiaries. Telemedicine is defined as clinicians encountering patients remotely in real time through audio …

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Genetic Test Maker 23andMe Hires Biotech Executive to Lead its Drug Development Effort

Google-backed genetic-testing company 23andMe is launching its own drug development unit, and bringing on former Genentech executive to become its chief scientist and lead the company’s research and development efforts. 23andMe has collected genetic information from more than 850,000 customers worldwide from its $99 DNA spit test and more than …

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Study Finds Radiation Plus Immunotherapy Combination May Elicit Optimal Response in Metastatic Melanoma Patients

Radiation therapy in combination with two immunotherapies could elicit an optimal response in more patients with metastatic melanoma, according to a new study. A team of researchers from Penn’s Abramson Cancer Center found that treating metastatic melanoma with a triple threat, including radiation therapy and two immunotherapies that target the …

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Merck Serono Partners with Illumina to Develop a University NGS-Based Oncology Diagnostic

Illumina announced that it is partnering with Merck Serono to develop a universal oncology diagnostic that uses next-generation sequencing (NGS). The companies will collaborate to develop a universal NGS-based oncology diagnostic for clinical trials of targeted cancer therapies, with the goal of a more comprehensive tool for precision medicine. The …

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FDA Approves United Therapeutics’ Rare Pediatric Cancer Drug and Gives the Company a Priority Review Voucher

US health regulators approved the first drug to treat pediatric patients with high-risk neuroblastoma, a rare cancer that develops on immature nerve cells. United Therapeutics Corporation announced that the US Food and Drug Administration (FDA) has approved Unituxin (dinutuximab) Injection, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and …

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