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FDA grants priority review for Abbvie’s hepatitis C therapy new drug applicationThe US Food and Drug Administration (FDA) has accepted and granted priority review to AbbVie's new drug application for its interferon-free regimen to treat adult patients with chronic genotype 1 (GT12014/6/17
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AstraZeneca signs licence agreement with Synairgen for asthma drugAstraZeneca has signed an exclusive global licence agreement for rights to Synairgen's SNG001, an inhaled interferon beta in clinical development for treating respiratory tract viral infections in pat2014/6/16
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Janssen and ViiV Healthcare to develop two-drug single tablet regimen for HIV-1Janssen R&D Ireland and ViiV Healthcare have announced a collaboration to develop and commercialise a new single tablet regimen containing Janssen's rilpivirine and ViiV's dolutegravir as the sole2014/6/16
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Scottish Medicines Consortium approves Defitelio for haematopoietic stem cell transplantationDrug approval body Scottish Medicines Consortium (SMC) has authorised Defitelio (defibrotide) for use as a supportive treatment for haematopoietic stem cell transplantation (HSCT) in treating patients2014/6/13
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Bayer seeks EU marketing approval for aflibercept solution for injection to treat macular edemaBayer HealthCare has filed an application to the European Medicines Agency (EMA) seeking marketing approval for aflibercept solution for injection to treat patients with macular edema following branch2014/6/13
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EffRx Pharmaceuticals receives FDA orphan drug designation for EX404EffRx Pharmaceuticals has received US Food and Drug Administration (FDA) orphan-drug designation for its proprietary metformin-based product, EX404, for treatment of paediatric polycystic ovary syndro2014/6/12
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Immunomedics receives orphan drug designation for IMMU-132 to treat pancreatic cancerImmunomedics has received orphan drug designation from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its IMMU-132 for pancreatic cancer therapy. IMMU-132 is Im2014/6/12
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Merck to acquire Idenix Pharmaceuticals for $3.8bnMerck has reached a definitive agreement worth $3.85bn to acquire Idenix Pharmaceuticals, a biopharmaceutical firm specialising in the discovery and development of drugs for treating human viral disea2014/6/11
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Edison’s Vatiquinone receives FDA orphan drug status for Leigh syndromeInherited mitochondrial disease treatment specialists Edison Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its vatiquinone to treat Leigh synd2014/6/11
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Biogen Idec receives FDA approval for haemophilia A drugBiogen Idec has received approval from the US Food and Drug Administration (FDA) for its Eloctate to control and prevent bleeding episodes, perioperative management, as well as routine prophylaxis in2014/6/10