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Biotech

245 published works

  1. The D&O Diary

    Biotech Hit with Securities Suit After Pandemic Impact on Clinical Trials

    By Kevin LaCroix

    A few days ago when I published a post discussing a new COVID-19-related securities lawsuit I expressed my surprise that pandemic-related suits were still being filed in 2024, particularly after…

  2. The Daily Intake

    Arizona Moves to Ban Lab-Grown Meat

    By Keller and Heckman LLP

    Arizona state representatives have introduced two bills relating to the sale of cell-cultured meat in the state. HB2121 would prohibit the sale or production of cell-cultured animal products, and HB2244…

  3. Prosecution First Blog

    Federal Circuit Follows Through on Amgen Enablement Analysis in Baxalta Inc. v. Genentech

    By Publisher

    Following the Supreme Court’s Amgen decision last summer,[1] the Federal Circuit has affirmed the invalidity of yet another functionally-defined antibody patent for lack of enablement in Baxalta Inc. v. Genentech,…

  4. Big Molecule Watch

    CRISPR Regulatory Updates

    By Stephanie Dusaban Gonzales

    On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of…

  5. China Justice Observer

    Shenzhen Issues China’s First Local Regulation on Cell and Gene Industry

    By Publisher

    The legislation refers to the “Regulation on the Promotion of Cell and Gene Industry in the Shenzhen Special Economic Zone” (hereinafter the “Regulation”, 深圳经济特区细胞和基因产业促进条例), which was adopted by the Standing…

  6. Health Law Prof Blog

    The Evolution Of Open Source Biotech – From Liberty To Justice

    By Katharine Van Tassel

    Jorge L. Contreras (University of Utah), The Evolution Of Open Source Biotech - From Liberty To Justice (2023): The COVID-19 pandemic has prompted a resurgence of interest in “open source” approaches…

  7. Food Safety News

    Biden sees future in ag biotech; food safety included

    By Cookson Beecher

    President Joe Biden is looking in another direction to steer agriculture’s boat. The key word here is biotechnology. And President Biden is all for it. In fact, he goes so…

  8. Health Law Prof Blog

    Dynamic Governance of Microbiome Innovation

    By Katharine Van Tassel

    Yao Zhou (Morgridge Institute for Research), Dynamic Governance of Microbiome Innovation (2023):Recent studies have shown that the microbiome has vast potential in the improvement of human health, agricultural productivity, and…

  9. Big Molecule Watch

    White House Announces “Bold Goals” for Biotech

    By Alison Siedor

    In a report entitled “Bold Goals for U.S. Biotechnology and Biomanufacturing,” the White House recently announced several biotech-related “bold goals” to advance the environmental, agricultural, economic, health, and science fields. …

  10. Health Care Law Today

    Building Biotech with Brains: Strategies for Maximizing Value of AI-Driven Biotechnology Inventions

    By Aashish R. Karkhanis, Jeffrey Simon

    The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this…