Category Archives: People

CEOs Sound Out on Health Reform: Stop Swinging from the Fence

At last week’s  4th annual Prix Galien Forum hosted by the Alexandria Center in New York, industry leaders gathered to discuss trends and developments that shape the intersection between science and policy.  The centerpiece of the day was a panel on  US health reform – focused on rollout of the  Affordable Care Act — featuring […]
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Belviq's Battle of the Bulge

Arena Pharmaceuticals’ and marketing partner Eisai’s Belviq – the first FDA-approved drug to treat obesity in over a decade – is making progress with payers and beefing up sales forces to target primary care physicians. DTC support began in September. Perhaps the most significant development in obesity of late is the recognition by payers – […]
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Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
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The Big Promise of Predictive Analytics in Healthcare

At Duke University’s Fifth Annual Technology and Healthcare Conference, Eric Siegel, founder of Predictive Analytics World and executive editor of the Predictive Analytics Times called new predictive analytical tools “inevitable” disruptions to the way physicians make treatment decisions and patients receive care. Whether you’re at a casino in Las Vegas, or a patient on the […]
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FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
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