Pharmaceuticals

  • Read more: Supreme Court Decision on FTC v. Actavis paves the way for development of cheaper drugs

    Supreme Court Decision on FTC v. Actavis paves the way for development of cheaper drugs

    By Arthur Caplan Zachary D Caplan JD, attorney at law firm in Philadelphia that filed amicus brief on behalf of drug wholesalers and pharmacies in FTC v. Actavis Arthur Caplan PhD, Division of Medical Ethics, NYU Langone Medical Center Amidst all the news about various Supreme Court decisions there is one that ought not be overlooked…

  • Read more: Supreme Court deals a major blow to reverse-payment settlements.

    Supreme Court deals a major blow to reverse-payment settlements.

    By Nicholson Price The Supreme Court keeps coming out with major opinions in the biotech/pharma area, with today seeing a major blow to reverse-payment settlements wherein brand-name pharma companies pay generic companies to delay their entry into the market.  This type of settlement shows the opposite pattern to that in most patent litigation, where the…

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

    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

    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

    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…