Pharmaceuticals

  • Read more: LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions
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    LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

    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…

  • Read more: Patients in Research: What the Professionals Don’t Get
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    Patients in Research: What the Professionals Don’t Get

    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.…

  • Read more: Unified Patents and Brexit: Britain’s Back on Board
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    Unified Patents and Brexit: Britain’s Back on Board

    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…

  • Read more: What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?
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    What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?

    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…

  • Read more: REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review
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    REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

    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…

  • Read more: Your Weekly Reminder That FDA Approval and Insurance Coverage Are Often Linked
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    Your Weekly Reminder That FDA Approval and Insurance Coverage Are Often Linked

    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…

  • Read more: The Precision Medicine Initiative and Access
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    The Precision Medicine Initiative and Access

    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…

  • Read more: Losing the Arms Race: Health Policy and Anti-Microbial Resistance
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    Losing the Arms Race: Health Policy and Anti-Microbial Resistance

    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,…

  • Read more: Violations of federal antifraud provisions alleged against two hepatitis B treatment producers
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    Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

    By Wendy S. Salkin Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1] Meller…

  • Read more: The Newest 21st Century Cures Draft Moderates, But Doesn’t Eliminate, Controversy
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    The Newest 21st Century Cures Draft Moderates, But Doesn’t Eliminate, Controversy

    By Rachel Sachs Earlier this evening, the House of Representatives released the most recent draft of the 21st Century Cures Act. This is the fifth time I’ve blogged about the Act (prior posts here, here, here, and here), which has ballooned from a 200-page discussion draft in April 2015 to a 996-page draft version today.…