regulatory landscape

By David Richardson, Research Team Leader The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies' payments to thought leader physicians and clinical...

By Shaylyn Pike, Senior Research Analyst Pharmaceutical companies' global clinical development strategies are diverse, but there are some points of agreement: clinical trials in emerging markets are more successful when companies hire local expertise....

By Eric Bolesh, Director of Research When we spoke with teams to complete our recent examination of companion diagnostics (CDx) development, we heard a lot about the difficulties of the partnering process. It’s a difficult road for all parties, as choosing...

By Elio Evangelista, Director of Research The promise of adaptive clinical trials leading to significant cost savings is attractive, and many drug companies have already put the strategy into practice. But most times, companies implement adaptive clinical...

By Jeremy Spivey,Senior Research Analyst The first few decisions of Germany’s new drug pricing body have arrived, and the results are mixed. Brilique (known as Brilinta in the United States) in December became the first product to complete the new product...

By Casey Ferrell,Research Analyst Joining the ever-growing list of organizations, associations and trade groups to weigh in on social media, the American Medical Association this week adopted a non-binding policy suggesting how physicians should go about...

By Casey Ferrell,Research Analyst Okay, it’s been almost 24 hours since ePharma Summit 2012 wrapped. Like a good holiday feast, if you did it right you’re probably still digesting the experience like I am. Day One’s symposia offered a more intimate...

Gone are the days when companies could use a healthcare provider's annual salary to calculate fair-market value (FMV) for their consulting services, according to the latest findings from our ongoing key opinion leader compensation research. The precision that...

Our recent study of Phase IV Trials found that post-marketing studies are increasingly "regionalized" to better meet U.S. and European market requirements. Differences in what regulators and payers are looking for in post-approval information in Europe and...

By Jeremy Spivey,Senior Research Analyst The Prescription Drug Cost Reduction Act, a bill introduced by Sen. Herb Kohl on October 13th, seeks to impose a number of new measures to reduce the US government's budget outlay on pharmaceutical and biotechnology...