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FDA rejects expanded use of Bayer and Janssen's anti-clot drug XareltoThe Food and Drug Administration has rejected the supplemental new drug applications seeking the use of Bayer and Janssen's anti-clotting drug Xarelto (rivaroxaban) for prevention of heart attacks or2014/2/20
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BioMarin's Vimizim gets FDA approval for treatment of Morquio A SyndromeUS-based BioMarin Pharmaceutical has received approval from the US Food and Drug Administration (FDA) to use its Vimizim (elosulfase alfa) for treatment of patients with mucopolysaccharidosis type IVA2014/2/19
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Samyang to distribute BMG Pharma's GelX in South KoreaItaly-based BMG Pharma has signed an exclusive distribution agreement with Samyang Biopharmaceutical for its novel mucositis management product, GelX. As part of the deal, Samyang receives the rights2014/2/19
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Hepatitis B Vaccine Market to Experience Modest Growth Despite Upcoming Product LaunchesThe global hepatitis B virus (HBV) vaccine market value will experience modest growth over the coming years, climbing from approximately $959.9 million in 2012 to $1.19 billion by 2022, at a Compound2014/2/18
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BioMarin's Vimizim gets FDA approval for treatment of Morquio A SyndromeUS-based BioMarin Pharmaceutical has received approval from the US Food and Drug Administration (FDA) to use its Vimizim (elosulfase alfa) for treatment of patients with mucopolysaccharidosis type IVA2014/2/18
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FDA Grants Accelerated Approval to ibrutinib for the Treatment of Patients with CLLOn 12 February 2014, FDA granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one2014/2/17
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Health Canada approves Otsuka and Lundbeck's once-monthly Abilify MaintenaHealth Canada has issued a notice of compliance for Otsuka and Lundbeck's Abilify Maintena, an intramuscular (IM) once-monthly injectable formulation, for the maintenance treatment of schizophrenia in2014/2/17
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European Universities and companies partner in €85m antibiotics development projectMore than 30 European universities and companies, led by GlaxoSmithKline (GSK) and Uppsala University in Sweden, are joining forces in a €85m six-year programme funded by the Innovative Medicines Init2014/2/14
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Health Canada approves Aegerion's JUXTAPID for homozygous familial hypercholesterolemia treatmentHealth Canada has granted a notice of compliance (NOC) approving Aegerion Pharmaceuticals' JUXTAPID, for treating a serious and rare genetic disease homozygous familial hypercholesterolemia (HoFH). J2014/2/14
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Ario Pharma Commences Phase IIa Trial of TRPV1 Inhibitor for Cough Associated with COPDArio Pharma Ltd, the Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, has commenced a Phase IIa study of its TRPV1 antagonist, XEN-0501, for the t2014/2/13