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Advaxis receives orphan drug designation for osteosarcoma immunotherapyAdvaxis has received orphan drug designation (ODD) from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its ADXS-cHER2, indicated for treatment of osteosarcoma.2014/5/29
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EMA adopts positive opinion on Octapharma’s haemophilia A drug NuwiqThe European Medicines Agency (EMA) has given a positive opinion towards Octapharma's human cell line recombinant human FVIII, Nuwiq, recommending the granting of marketing authorisation for treatment2014/5/29
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Teva and Active Biotech to Continue with the Development of Nerventra (Laquinimod) for MS Following Confirmation of CHMP OpinionTeva Pharmaceutical Industries Ltdand Active Biotechhave announced that the Committee for Medicinal Products for Human Use (CHMP) confirmed its 23 January 2014 opinion to recommend against approval fo2014/5/28
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Health Canada approves Janssen’s type 2 diabetes mellitus medicationJohnson & Johnson subsidiary Janssen has announced Health Canada's approval for Invokana (canagliflozin), indicated as an adjunct to diet and exercise to improve glycemic control in adult patients2014/5/28
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Alcon Receives Positive CHMP Opinion for Simbrinza, a New Fixed-Dose Combination Medicine to Treat Patients with GlaucomaAlcon,a global leader in eye care and division of Novartis, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive op2014/5/27
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FDA Approves First-Line Use of Vectibix (Panitumum​ab) Plus FOLFOX for Patients with Wild-Type KRAS Metastatic Colorectal CancerAmgenhas announced thatFDA has approved Vectibix (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (e2014/5/27
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FDA grants orphan drug status to Inhibikase's imatinib to treat PMLThe US Food and Drug Administration (FDA) has granted orphan drug designation to Inhibikase Therapeutics' imatinib for treatment of progressive multifocal leukoencephalopathy (PML). PML is a rare sid2014/5/26
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Protalix gets marketing approval in Australia for ELELYSO to treat Gaucher diseaseIsrael-based biopharmaceutical firm Protalix BioTherapeutics has received approval from the Australian Therapeutic Goods Administration (TGA) for ELELYSO (taliglucerase alfa) for injection, as a long-2014/5/26
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Abbvie gets FDA orphan drug status for HUMIRA to treat non-infectious uveitisThe US Food and Drug Administration (FDA) has granted orphan drug designation for AbbVie's HUMIRA (adalimumab) to treat non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectiou2014/5/23
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Japanese Ministry grants orphan status to Edison's EPI-743 to treat Leigh syndromeThe Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan designation to Edison Pharmaceuticals' EPI-743, an orally bioavailable small molecule, being developed for the treatment o2014/5/23