Author Archives: Ben Comer

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 – […]
Posted in Advertising, FDA, Global, healthcare, Market Access, Marketing, Patient Communication, People, pricing, Regulatory, Safety, Sales, Strategy | Tagged , , , , , , , , , , , , , , | Leave a comment

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 […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Tagged , , , , , , , , | 1 Comment

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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Ever Bullish, Al Mann Says Afrezza is Coming in Mid-April

Post Exubera, inhaled insulin has been an uphill struggle with regulators. Alfred Mann and MannKind are nonetheless determined to push Afrezza, an ”ultra” rapid-acting mealtime insulin, over the regulatory peak and into the market. Will they succeed, or is MannKind doomed to play Sisyphus on mount FDA? It would be in large part due to […]
Posted in FDA, People, pricing, R&D, Regulatory, Safety, Strategy, Technology | Tagged , , , , , , , | 3 Comments

With Cannabis, Science Trumps Culture, Says GW Pharma CEO

Already approved in 22 countries, GW Pharma’s Sativex product, if approved by FDA, would become the first prescription drug derived from raw cannabis to enter the US market. In the last several years, the US – a place where marijuana still has a decidedly bad reputation, and a prosecutorial history tinged with socioeconomic bias, if […]
Posted in Europe, FDA, Global, Legal, People, R&D, Regulatory, Strategy, Technology | Tagged , , , , , , , , | 2 Comments
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