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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investor suit with $400M settlementPfizer ($PFE) got a federal judge to toss an investor lawsuit last year tied its now-withdrawn pain drugBextra.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
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Roche to acquire majority stake in Foundation Medicine for $1.3bnSwiss drugmaker Roche is set to invest $1.3bn to acquire a 56.3% stake in US-based Foundation Medicine (FMI), in a bid to expand treatment options for cancer patients. Roche will tender 15.6 million2015/1/23
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GSK Consumer to acquire Novartis OTC business in India for $17mNovartis India has approved transfer of its over-the-counter division (OTC) division to GlaxoSmithKline Consumer (GSK CPL), for Rs1.97bn ($17.6m). GSK CPL is a consumer healthcare joint venture (JV)2015/1/19
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Armed with Pegasus win, AstraZeneca targets another sales boost for BrilintaSoon after CEO Pascal Soriot took over at AstraZeneca ($AZN) in 2012, he declaredBrilintato be a big opportunity for growth. That was a surprise, given the blood thinner's laggardly sales since its 202015/1/15
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UPDATED: JPM: Glaxo ready to shift off Advair; BMS isn't afraid of Merck; Roche eyes combos and M&ASAN FRANCISCO--Here's a game to play at the annual JP Morgan Healthcare Conference. Attend presentations by executives at Big Pharma, Big Biotech, and slightly less big biopharma companies, hoping to2015/1/15
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Roche bets $1.2B on Foundation Medicine with deal for majority stakeRoche ($RHHBY) is throwing the full weight of its global rep and more than $1 billion behind Foundation Medicine's ($FMI) ambitious sequencing technology, designed to tailor cancer treatments to parti2015/1/13