"The Pink Sheet" – Most Notable Stories Of 2010
Executive Summary
While industry mega-mergers occupied readers in 2009, the focus in 2010 shifted toward several evolving policy concerns and their impact on company strategy. Among these, more companies are looking at the opportunity for biosimilars created by the health care reform law's provision of a legal framework for product approval. But early analyses suggest that there is still a lot of work to do as FDA develops a guideline for industry on an abbreviated approval pathway.
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