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CFDA issues Guiding Opinions on Enhancing the Construction of Food and Drug Inspection and Testing SystemTo further enhance the construction of the food and drug inspection and testing system and better play the role of inspection and testing as technical support, China Food and Drug Administration (CFDA2015/2/4
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Janssen and Pharmacyclics receive FDA approval for Imbruvica to treat WMJanssen Biotech and Pharmacyclics have received approval from the US Food and Drug Administration (FDA) for Imbruvica (ibrutinib) capsules as the first therapy indicated specifically for patients with2015/2/4
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Roche's anti-PDL1 receives FDA breakthrough therapy designation to treat NSCLCThe US Food and Drug Administration (FDA) has granted second breakthrough therapy designation for Swiss drug-maker Roche's investigational cancer immunotherapy, MPDL3280A. The company has received ap2015/2/3
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Branded drug prices leapt almost 15% last year, led by pain pills, COPD and heart medsIt's no secret that branded drugmakers often rely on price hikes to keep U.S. sales growth coming, especially on older meds whose patents are close to the ends of their lives. But according to new dat2015/1/30
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GSK and Novartis three-part transaction receives European approvalGlaxoSmithKline (GSK) has obtained approval from the European Commission (EC) for its three-part transaction with Novartis. The deal includes the acquisition of Novartis's vaccines business, excludin2015/1/30
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BioCryst’s BCX4161 receives FDA fast-track designation to treat HAEBioCryst Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for its BCX4161, an orally administered and selective inhibitor of plasma kallikrein in adva2015/1/28
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Pfizer extricates itself from investor suit with $400M settlementPfizer ($PFE) got a federal judge to toss an investor lawsuit last year tied its now-withdrawn pain drugBextra. But it wasn't the only investor suit raising similar issues, namely that the board had n2015/1/28
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CFDA issues Good Supply Practice for Medical DevicesTo strengthen the quality management of medical device distribution, standardize medical device distribution behaviors, and guarantee the safety and effectiveness of medical devices, China Food and Dr2015/1/27
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CFDA issues Good Manufacturing Practice for Medical DevicesIn order to strengthen the supervision and management of medical device manufacturing, standardize quality management, and further ensure the safety and effectiveness of medical devices, China Food an2015/1/26
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The first Sabin IPV approved by CFDAOn January 14, 2015, China Food and Drug Administration (CFDA) approved the production of the first inactivated poliomyelitis vaccine made from Sabin strains (Sabin IPV) (single component), which was2015/1/23