By Dov Fox So much new data are created every day that 90 percent of all data worldwide has emerged in just the last two years. This information revolution has the potential, argues Bill of Health guest blogger Ryan Abbott, to transform how we develop new drugs, set clinical practices, and finance health care. His interesting new article paints an alluring “vision…
By Adriana Benedict As Jonathan Darrow notes below, on Monday, the Supreme Court heard oral arguments in Federal Trade Commission (FTC) v. Actavis, the “pay for delay” case questioning whether or not reverse payment settlements in Hatch-Waxman litigation should be presumptively anticompetitive, a question on which the Circuit Courts are divided. This particular case involves…
By Dan Vorhaus [Cross-posted from Genomics Law Report] Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th). The hearings,…
By Dov Fox We’re not talking vasectomies or condoms. Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that…
By The Petrie-Flom Center Petrie-Flom Center Annual Conference: The Food and Drug Administration in the 21st Century Friday and Saturday, May 3-4, 2013 Harvard Law School, Cambridge, MA The Petrie-Flom Center invites you to attend our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.” Attendance is free and open to the public.…
Please join the HMS Division of Medical Ethics for … “Why patients should have access to all drugs without a prescription” Jessica Flanigan, PhD Assistant Professor of Leadership Studies and Philosophy, Politics, Economics and Law University of Richmond Thursday, March 28, 2013; 4:00 – 5:30 PM HMS Division of Medical Ethics 1st Floor Conference Room…
By The Petrie-Flom Center A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard: Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions May 17, 2013, 8:00AM-5:00PM Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor) 1585 Massachusetts Ave.,…
By The Petrie-Flom Center
By Jonathan J. Darrow Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb.…
By The Petrie-Flom Center
