Pharmaceuticals

  • 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.…

  • Read more: Jordan Paradise on ‘The Week in Health Law’ Podcast
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    Jordan Paradise on ‘The Week in Health Law’ Podcast

    By Nicolas Terry and Frank Pasquale Subscribe to TWIHL here! Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes.  Her publications have appeared in both peer-reviewed and legal publications. We start with a review of some of the…

  • Read more: CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”
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    CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

    2017 Annual Conference Call for Abstracts: Transparency in Health and Health Care – Legal and Ethical Possibilities and Limits April 28, 2017  Wasserstein Hall, Milstein East ABC (2036) Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for…

  • Read more: “That I Don’t Know”: The Uncertain Futures of Our Bodies in America
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    “That I Don’t Know”: The Uncertain Futures of Our Bodies in America

    By Wendy S. Salkin I. Our Bodies, Our Body Politic On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews.…

  • Read more: Understanding Financial Toxicity
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    Understanding Financial Toxicity

    By Zack Buck In the ongoing fight to control the cost of health care, new understanding of the phenomenon of financial toxicity could play a vital role.  Seen currently in the long-term cancer context, recent studies (here and here, and discussed here and here) have shown that individuals experiencing financial distress as a result of the cost…

  • Read more: Standards, Data Exchange and Intellectual Property Rights in Systems Biology
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    Standards, Data Exchange and Intellectual Property Rights in Systems Biology

    By Timo Minssen I am happy to announce that our recent paper on “Standards, Data Exchange and Intellectual Property Rights in Systems Biology” has been published in the Biotechnology Journal Vol 11, Issue 12, pp. 1477-1480.  The paper was co-authored by Esther Van Zimmeren from the University of Antwerp, Berthold Rutz from the European Patent Office and me. Please…

  • Read more: Drug prices: Where do we go after the Election?
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    Drug prices: Where do we go after the Election?

    By Rachel Sachs, Washington University in St Louis[Originally published on The Conversation] Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, a Kaiser Health Tracking Poll released Oct. 27 suggests many people care more about the…

  • Read more: Biosimilars – In The Pipeline or Still a Pipe Dream?
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    Biosimilars – In The Pipeline or Still a Pipe Dream?

    By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq. The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of…

  • Read more: Bioethicist Art Caplan: Right-To-Try Laws For The Terminally Ill Are Bad Policy
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    Bioethicist Art Caplan: Right-To-Try Laws For The Terminally Ill Are Bad Policy

    By Arthur Caplan A new piece by Bill of Health contributor Art Caplan in Forbes: Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong. Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have…