By Rachel Sachs Yesterday, a federal district judge made an important ruling in the ongoing patent dispute between Amgen’s cholesterol-lowering drug Repatha and Sanofi and Regeneron’s drug, Praluent. Early in 2016, Amgen’s patents covering the products had been found both valid and infringed, and now Judge Sue Robinson has granted Amgen’s request for an injunction…
Health Law Year in P/Review Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration January 23, 2017 Wasserstein Hall, Milstein West AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during…
Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions Monday, December 19, 2016, 12:00 – 1:00pm WATCH LIVE ONLINE!: https://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda Submit your questions to the panelists via Twitter @PetrieFlom. Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will…
By Rebecca Dresser When scientists and doctors get together to talk about accelerating medical advances, someone inevitably brings up the need for more research subjects. Not enough patients are participating in clinical trials, experts complain. If more patients were part of medical studies, we could make more progress in treating disease and improving human lives.…
By Seán Finan After several failed attempts, years of protracted negotiations and a glacial ratification process, it seemed as if Brexit would finally put an end to the nascent European Unitary Patent. Last week, however, the UK confirmed its intention to ratify the Unified Patent Court Agreement and to move forward with the plans for the…
By Rachel Sachs Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here…
Health Law Year in P/Review Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration January 23, 2017 Wasserstein Hall, Milstein West AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during…
By Rachel Sachs In recent days, it seems like the din of voices arguing that the FDA should approve pharmaceuticals more speedily and on less evidence has grown louder. It is a central theme of the 21st Century Cures Act, which the House may vote on today and which I seemingly will never finish blogging…
By Leslie Francis Persistent differences in participation in clinical trials by race and ethnicity are well known; for example, the 2015 Report of the Working Group on Precision Medicine (PMI) relies on statistics that only 5% of clinical trial participants are African-American and only 1% are Hispanic. A recently-launched website of the FDA, “Drug Trials…
By Seán Finan And scattered about it, some in their overturned war-machines, some in the now rigid handling-machines, and a dozen of them stark and silent and laid in a row, were the Martians–dead!–slain by the putrefactive and disease bacteria against which their systems were unprepared; slain as the red weed was being slain; slain,…
