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21st Century Cures discussion draft includes textbook/reprint language, communication fixes

By John Kamp New legislation to spur medical innovation through new authorities for FDA and NIH is creating a lot of buzz in the Washington medical community, most of it very good. Indeed, even with outgoing FDA Commissioner Margaret Hamburg’s March 30 note of caution that regulatory innovation requires increased staff and other resources, the passage […]

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Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval?

As the waistline of Americans has increased, so has the incidence of Type 2 diabetes. Startling data from the Centers for Disease Control  shows that that prevalence of this disease, which is directly related to obesity, now exceeds 9% in the adult population. It was less than half that rate in 1996. Furthermore, there doesn’t […]

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Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels. […]

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PerkinElmer Launches First Fully Automated Genetic Disorder Screening System in China

WALTHAM, Mass. & SHANGHAI–(BUSINESS WIRE)–PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, today announced that it has received market authorization from the China Food and Drug Administration (CFDA) to offer its Genetic Screening Processor® (GSP) instrument and GSP Neonatal hTSH reagent kit. The GSP is a […]

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FDA panel backs safety updates for AstraZeneca, Takeda drugs

A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Reuters/Phil Noble (Reuters) – AstraZeneca Plc’s diabetes drug Onglyza and Takeda Pharmaceutical Co.’s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday.   Heart […]

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U.S. Solicitor General Intervenes Against Johnson & Johnson in DECN’s Long Running Patent Battle Over GenStrip 50

Interventions by the Solicitor’s Office to Protect the Rights of a Corporation Are Rare LOS ANGELES, CA–(Marketwired – Apr 14, 2015) – Decision Diagnostics Corp. (OTC PINK: DECN), the manufacturer, quality plan administrator and the exclusive worldwide sales, service and regulatory processes agent for the popular GenStrip™ 50, the FDA cleared Green Alternative Strip, specifically […]

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Healthcare ad agency recruiting 101: A Q&A with Matthew West

Matthew West spent 14 years at McCann RCW as VP/chief talent officer; now West is a director of AdvicePersonnel, a boutique recruitment company, where he specializes in finding talent for healthcare advertisingagencies. In an industry where every agency president says good talent is difficult to find, West has someinsights about where to find it and […]

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Traditional channels still tops

Traditional channels remain the dominant form of HCP interaction in 13 major pharmaceutical markets, according to research by Cegedim Strategic Data. The company’s Global Promotion Audits showed varying levels of digital penetration across major markets – led by 34 percent in Japan and 24 percent in the United States – but in all cases the […]

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How to chase unicorns

There are at least 40,000 practicing hospitalists in the United States, and though these physicians are elusive, their ranks are growing   By Kristin Scott, Society of Hospital Medicine   Back in the late ‘90s and early 2000s, pharmaceutical representatives with hospital accounts were considered “specialty” representatives and had responsibilities for talking to medical students, […]

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Is it really working?

SalesandMarketing Measuring campaign ROI in the age of tapestry marketing  By Chris Nelson Ever been to a brand campaign case study presentation at one of those big-name health care marketing conferences? You know, where the brand manager and agency lead get up in front of the audience and show off their brilliant new TV/digital/mobile/social/(insert medium […]

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