1. FDA’s decision to remove the breast cancer indication from the label of bevacizumab (Avastin).
2. Approval of Dendreon’s sipuleucel-T (Provenge), representing a new class of drug.
3. Sanofi-Aventis’ pursuit of Genzyme. It illustrates an industry move towards adding orphan and rare therapeutic areas to pharma portfolios. Another example of the trend came when Pfizer created orphan disease research division in 2010 and acquired FoldRx Pharmaceuticals.
4. The amount of free drug supplied to patients in 2010 reached record highs according to PhRMA, which cited the economic downturn.
5. Increased collaboration between pharma and academic research centers, indicating a shift to go beyond biotech to fill pipelines. Examples include Pfizer’s collaborations with UC San Francisco, Washington University in St. Louis, and Sanofi’s collaborations with The Scripps Research Institute, Harvard University, and the Dana-Farber Cancer Institute.
Top 5 Things to Look for in 2011
1. An escalating legal battle over the constitutionality of President Obama’s healthcare reform legislation.
2. Implementation of the pharma tax, which is expected to raise $2.3 billion a year, and will target branded prescription drug sales of more than $5 million to Medicare and other government programs.
3. Rethinking biopharma and physician relationships in light of the implementation of the Sunshine Act in 2012.
4. Increased use of adaptive trial design and how/if the FDA will address this new approach to clinical development.
5. As the economy continues to recover, will the IPO window open up?
[Editor’s Note: This is part of a series of posts from Xconomists and other technology and life sciences leaders from around the U.S. who are weighing in with the top surprises they’ve seen in their respective fields in the past year, or the major things to watch for in 2011.]
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