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EMA grants orphan drug status to ImmunoCellular's brain tumour treatmentThe European Medicines Agency (EMA) has granted orphan drug designation for ImmunoCellular Therapeutics' lead product candidate ICT-107 for treatment of patients with glioblastoma. EU orphan drug sta2014/3/3
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Iroko's lower dose pain drug Tivorbex obtains FDA approvalUS-based Iroko Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to use Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20mg and2014/2/28
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FDA accepts BioCryst’s NDA for intravenous anti-viral drug peramivirBioCryst Pharmaceuticals has announced that the new drug application (NDA) for its intravenous peramivir has been accepted for review by the US Food and Drug Administration (FDA). In December 2013, B2014/2/28
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AstraZeneca's orphan drug Myalept obtains FDA approval for treatment of leptin deficiencyThe US Food and Drug Administration (FDA) has approved AstraZeneca's Myalept (metreleptin for injection) as replacement therapy for the treatment of complications of leptin deficiency in patients with2014/2/27
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Japanese authorities approve fourth indication for Genentech-Novartis' eye drug LucentisThe Japanese regulatory bodies have approved Lucentis (ranibizumab) for a fourth indication for treatment of patients with diabetic macular edema (DME), a major cause of vision loss among diabetic pat2014/2/27
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FDA Approves KALYDECO (Ivacaftor) for Use in Eight Additional Mutations that Cause Cystic FibrosisVertex Pharmaceuticals Incorporated hasannouncedFDA approved a supplemental New Drug Application (sNDA) for KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of e2014/2/26
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FDA grants breakthrough designation to Bristol-Myers Squibb's investigational hepatitis therapyThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Bristol-Myers Squibb's investigational DCV Dual Regimen (daclatasvir (DCV) and asunaprevir (ASV)) for use as2014/2/26
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EMA panel issues positive opinion for lung drugs Anoro and IncruseThe European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline (GSK) and Theravance'2014/2/25
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Schizophrenia Treatment Market: Novel Products to Provide Slight Boost by 2022, While Unmet Needs RemainThe global schizophrenia treatment market value is expected to undergo a modest increase over the coming decade, climbing from $6.3 billion in 2012 to $7.9 billion by 2022, at a Compound Annual Growth2014/2/25
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Catalent Appoints New Vice President and General Manager for European Softgel BusinessCatalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has appointed Robert Beland to the2014/2/24