Pharmaceuticals

  • Read more: Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies
    Article

    Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

    By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H. Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon…

  • Read more: Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
    Article

    Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

    By W. Nicholson Price II [Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging – see posts below)]  The first panel of today is on regulatory exclusivity and generic drugs, moderated by Ben Roin at the Petrie-Flom Center. Leading off was Kate Greenwood, discussing orphan drug development…

  • Read more: Branded Drugs and Generics: Reverse Payment Settlement Agreements
    Article

    Branded Drugs and Generics: Reverse Payment Settlement Agreements

    By Jonathan J. Darrow Earlier this week the Supreme Court heard oral arguments in FTC v. Actavis, in which the Federal Trade Commission is asserting that it is impermissible for a brand name drug company to pay a generic drug company to stay out of the market. Normally, such collusive behavior would constitute a clear…