On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade...more
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more
In the pharmaceutical industry, intense competition has been going on for years between "branded" drug manufacturers and "generic" competitors for the same drugs. This competition has taken place under the carefully balanced...more
Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009...more
According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which...more
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