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Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced that it has received CE Mark for its blood test to aid in detecting liver cancer among patients with cirrhosis two months ahead of schedule. The test will be commercialized under the brand name “HCCBloodTest”. In 2019, the company plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China.

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Wound Care Advantage, a leading provider of management and consulting services for outpatient wound care and hyperbaric medicine programs, today announced a partnership with Tissue Analytics, the world's leading mobile imaging and artificial intelligence (AI) platform for wound management. The partnership allows for WCA to leverage its clinical expertise and 17 years of clinical data with Tissue Analytics' imaging and AI to improve the accuracy of measurement during wound assessments and provide better insights into the efficacy of wound treatments to improve patient outcomes and reduce costs.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced updated results from the ongoing Phase I study of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

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In what can be termed as a milestone in the fight against tuberculosis (TB), a vaccine by pharma major GlaxoSmithKline (GSK) could be the first new jab against the infectious disease developed in a century.

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The Prix Galien USA Committee last night honored excellence in the biopharmaceutical and medical industry for research, development and innovation at its 12th annual Prix Galien Awards Gala, held at the American Museum of Natural History in New York City. In recognition of the development and discovery of products that improve the human condition, a committee of highly accomplished scientific leaders, inclusive of four Novel Laureates, recognized winners in three categories: "Best Pharmaceutical Product," "Best Biotechnology Product," and "Best Medical Technology." This year, the Committee has chosen two winners in the Biotechnology category.

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The growing availability of real-world data has generated tremendous excitement in health care. By some estimates, health data volumes are increasing by 48% annually, and the last decade has seen a boom in the collection and aggregation of this information. Among these data, electronic health records (EHRs) offer one of the biggest opportunities to produce novel insights and disrupt the current understanding of patient care.

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One of the gating factors in studying the human brain is having the ability to conduct research on actual functioning human brain tissue. As a result, many scientific studies are conducted on rodents as a mammalian proxy. The drawback to this approach is that rodent brains are different in structure and function. According to Johns Hopkins, structurally, the human brain is approximately 30 percent neurons and 70 percent glia, while the mouse brain has the opposite ratio [1].

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The Foundation for the National Institutes of Health (FNIH) awarded to Michael Fox, M.D., Ph.D., of Beth Israel Deaconess Medical Center and Harvard Medical School the inaugural Trailblazer Prize for Clinician-Scientists (Trailblazer Prize) at the FNIH Annual Fall Board Dinner in Washington, D.C. Dr. Fox received the Trailblazer Prize and a $10,000 honorarium for pioneering innovative techniques to map human brain connectivity that can be translated into new treatments for neurological diseases, such as Parkinson’s disease and depression. The Trailblazer Prize is made possible by a generous donation from John I. Gallin, M.D., and Elaine Gallin, Ph.D., to the FNIH.

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Thrombocytopenia is a big word that can carry big consequences for those struggling with rare blood disorders, especially among those using heparin to treat and prevent blood clots. But, help is on the way. The National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) recently awarded VERALOX Therapeutics, a small molecule drug discovery and development company, a $319,133 Small Business Innovation Research grant to develop a novel therapeutic for patients suffering from heparin-induced thrombocytopenia and thrombosis (HIT/HITT).

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AstraZeneca, and its global biologics research and development arm MedImmune, today announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines.

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American Gene Technologies (AGT), a leading gene and cell therapy company in the discovery and development of lentiviral vector based therapeutics, announces that the U.S. Food and Drug Administration (FDA) received orphan-drug designation #DRU-2018-6572 for the treatment of phenylketonuria (PKU) using its proprietary, lentiviral vector based technology. PKU is a debilitating inherited disease affecting 1 in 13,500 children born in the U.S. Mandatory screening identifies affected children who can be supported with a strict synthetic diet that does not cure disease. If successful, AGT's lentiviral vector approach will provide a permanent cure, improving quality of life for more than 16,000 people living with PKU in the U.S. alone.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that Ultragenyx Pharmaceutical Inc. has exercised an option for an exclusive worldwide license to REGENXBIO's NAV Vectors, including NAV AAV9, for the treatment of CDKL5 Deficiency Disorder (CDD).

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Children benefit from little of the $156 billion annual U.S. market for medical devices, but a “Shark Tank”-inspired partnership between the University of Maryland and Children’s National Health System is looking to change that.

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The U.S. Department of Health and Human Services (HHS) is doing everything from sharing more data to cultivating entrepreneurial talent and engaging in partnerships in order to support medical device innovators, the department’s CTO Ed Simcox told than 100 industry insiders in the Twin Cities today.