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CFDA issues Guideline for Technical Review of Medical Device Software RegistrationOn August 5, 2015, China Food and Drug Administration (CFDA) issued the Guideline for Technical Review of Medical Device Software Registration. The Guideline is for guiding manufacturers to submit app2015/8/12
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Perrigo makes last-minute investor pitch as Mylan lays out Plan BThere's just over two weeks left until Mylan's ($MYL) shareholders vote on its proposed hostile takeover of Perrigo ($PRGO), and the Irish target is using the time to meet with shareholders of both co2015/8/12
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GSK site closed after legionella bacteria detected in cooling towersAfter detecting the bacteria for Legionnaires' disease in its cooling towers, GlaxoSmithKline ($GSK) has temporarily closed a manufacturing site in North Carolina and sent employees home while it clea2015/8/12
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Mallinckrodt amps up hospital business with $1.3B Therakos buyMallinckrodt has made its second buy of the year--and the company believes it's the perfect match for its first purchase. The Irish drugmaker agreed to fork over about $1.33 billion to investment fir2015/8/11
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Novartis and Cyndi Lauper just want psoriasis patients to have funNovartis ($NVS) is working hard to build up market share for new psoriasis medCosentyxahead of its forthcoming competition, and it's signed on '80s icon Cyndi Lauper to help. Lauper and the National P2015/8/11
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Actavis gets subpoena as DOJ probe of generic pricing moves up food chainAllergan ($AGN) may be shedding its background as a generic drug company with a name change and a $40 billion deal to sell that piece of its business, but it hasn't eluded federal investigators intent2015/8/10
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Amarin wins injunction against FDA in free speech caseOn Friday, Amarin ($AMRN) won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its f2015/8/10
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Short-sellers target Bavarian Nordic and its cancer vaccine candidateAs it works to bring its prostatecancer vaccineProstvac to market and expand its smallpox vaccine business, Danish vaccine makerBavarian Nordic encountered a new set of challenges this week. Despite a2015/8/7
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Mylan CEO Bresch: We want Perrigo--but we don't need itPerrigo CEO Joseph Papa said this week that he doesn't intend to make it easy for Mylan to pull off a hostile takeover of his company. But the way Mylan sees it, if it loses out, it's not the end of t2015/8/7
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Novo Nordisk launches diabetes 'dream team' contest with NBA star as a prizeFormer NBA star Dominique Wilkins is not just a spokesman for Novo Nordisk's ($NVO)Victoza. He's also a prize in a Type 2 diabetes sweepstakes the drugmaker is rolling out. Through the company's "Diab2015/8/6