Category Archives: Op-Ed

Obamacare: Questions for Pharma in 2014

Tom Norton outlines the Obamacare-related questions that are likely to be of concern to pharma companies in the U.S. this year. I t’s expected that about 35 new FDA approved prescription drugs will arrive on the market in 2014. What are the chances that these new medications will be utilized by Obamacare health programs?  Given […]
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Europe: Early Communications with Regulators is Essential for SMEs

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process. Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative […]
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Engage, But Gently: More Top Line Thoughts on 2014

More Top Line Thoughts on 2014:  Engage, but Gently Two weeks in and the New Year already seems old.  Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets – forward and backward – over […]
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Budgeting for Patient Outcomes Research

By Marylyn Donahue. The Patient-Centered Outcomes Research Institute (PCORI) has approved a two-year commitment to spend more than $1 billion in funding for comparative effectiveness research (CER) projects. Critics had been clamoring for its research agenda to be more strategic, so it could address research questions that comparative effectiveness research would answer quickly and decisively. So […]
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Obamacare and U.S. Pharma: Two Months In

U.S. Pharma in the Eye of the Obamacare Storm So, we’ve experienced two months of Obamacare.  How is the U.S. pharmaceutical industry doing with this new program?  I spent two weeks getting the opinions of several Rx representatives on their experience with Obamacare, as well as their thoughts on how it is impacting their marketing, […]
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