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GSK and Genmab seek FDA approval for ofatumumab combination therapy for CLL first-line treatmentGlaxoSmithKline (GSK) and Genmab have submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking the use of Arzerra (ofatumumab) in combination2013/10/22
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1M fake Xanax pills intercepted on their way to Egypt from ChinaHow much do 1 millionXanaxpills weigh? About 400 kilograms (880 pounds), according to the drug regulator Swissmedic, which discovered 1 million counterfeit Xanax pills on a jet headed fromChinatoEgypt2013/10/21
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Pfizer gets European approval for label update of pneumococcal conjugate vaccine Prevenar 13Pfizer has received European Commission approval for updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in certain hig2013/10/21
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Safety group flags bleeding reports on Pradaxa, Xarelto and old standby warfarinThe Institute for Safe Medication Practices (ISMP) has flagged its latest set of side-effect reports to the FDA--and once again,anticoagulantdrugs are at the top.BoehringerIngelheim'sPradaxa, a new-ge2013/10/18
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Isis receives milestone payment from Biogen Idec for advancement of dystrophy drugUS-based drug developer Isis Pharmaceuticals has obtained a $10m payment from Biogen Idec for the development of a potential treatment for myotonic dystrophy, a chronic, slowly progressing, highly var2013/10/18
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Novo Nordisk nabs FDA approval for hemophilia fighter NovoEightNovo Nordisk is known for its dominance in the diabetes market. The company sports 5 of the 10 top-selling diabetes remedies worldwide. But the company has a stash of other treatments, and it just add2013/10/17
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Sanofi invests in Fabrazyme production as sales soarNew plant has allowed Genzyme to overcome shortages of rare-disease drug Sales of Sanofi's rare-disease drugFabrazymehave been on an upward trajectory since it got on top of supply issues last year w2013/10/17
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Cancer immunotherapies set to storm onto the market, analysts sayOver the past year the excitement in biopharma R&D circles about the therapeutic punch of cancerimmunotherapieshas reached fever pitch, and the intense R&D focus hasn't escaped the notice of t2013/10/16
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Chinese-produced vaccine prequalified by WHOOn October 9, 2013, the World Health Organization (WHO) notified China Food and Drug Administration that the live attenuated Japanese encephalitis vaccine produced by Chengdu Institute of Biological P2013/10/16
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Pfizer exec Amy Schulman talks gender, power and company policyIn an interview withThe New York Times, Pfizer SVP and General Counsel Amy Schulman has some advice for ambitious women. Soon to leada new vaccines, oncology and consumer health division at Pfizer ($P2013/10/15