Pharmaceutical manufacturers are confronted with a major decision regarding compliance with current and impending serialization requirements for products they sell ...

On September 18th, 2013, Clarkston co-sponsored and attended Pennsylvania Bio’s Leadership Panel Program’s Fall CEO Roundtable, which brought together executives, ...

The road to market for a novel biotech therapy is among the most expensive, demanding courses for entrepreneurs to undertake, ...

Last week, a major pharmaceutical company, Eisai Inc., sued the Drug Enforcement Administration (DEA), the very agency that stands between ...

In the case of Mutual Pharmaceutical Co. Inc. v. Bartlett, the Supreme Court overturned a lower court ruling that awarded ...

Fortune 500 CEO Indra Nooyi recently provided her perspectives on sustainable capitalism at the ICGN Annual Conference in New York ...

The economics of pay-for-delay agreements are clear – branded drug makers benefit from an extended amount of time on the ...

In one of my earlier blogs, Removing the Mystery for Serialization Stakeholders, I talked about the need to identify internal ...

“We’ll cross that bridge when we get there.” This is the typical approach most of us take on post-production matters ...

As if serialization efforts aren’t complicated enough working within our own manufacturing organizations, syncing our efforts with our trading partners ...

As organizations plan their serialization initiative, I often find that the effort required to validate the complete solution is underestimated.  ...

Combination drugs continue to grow in popularity as novel alternatives and advances in biotechnology, pharmaceuticals and medical devices.  The market ...