News & Analysis as of

Genetic Materials Healthcare

Epstein Becker & Green

Texas Supreme Court Declines Opportunity to Hear Personhood Case

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On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law....more

Epstein Becker & Green

Update: Alabama Legislature Moves to Shield IVF from “Personhood” Ruling

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In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...more

Knobbe Martens

The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease

Knobbe Martens on

On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies: Insights on Coverage, Reimbursement and Emerging Models

Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more

Perkins Coie

New My Health My Data Act Part 3: The Wide Reach of the New Washington Privacy Legislation

Perkins Coie on

This Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act (the Act). Part 1 provided a high-level outline of the entities regulated under the Act and the corresponding...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Nelson Mullins Riley & Scarborough LLP

The Promise of Brain-Delivered Gene Therapy

Gene therapy aims to treat the underlying genetic cause of a disease rather than only the symptoms. It involves the delivery of properly functioning DNA into a patient’s genetic material to correct an underlying genetic...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Issue 23, 2022

Complex, Customized CRISPR Combo Could Help Patients Cure Their Own Cancer - “In a small phase 1 clinical trial run by PACT Pharma, researchers edited the genes of 16 patients’ immune cells to work against their cancer,...more

WilmerHale

The Potential Impacts of the Nagoya Protocol on Global Public Health Research

WilmerHale on

The State Department is initiating a public process to consider the implications of Access and Benefit-Sharing (ABS) regimes for global health and biomedical research. The Federal Register Notice announcing this initiative...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Cell and gene therapies

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Franczek P.C.

EEOC Issues Proposed Rule on Wellness Programs and GINA

Franczek P.C. on

The Equal Employment Opportunity Commission (EEOC) has issued a proposed rule amending prior regulations under the Genetic Information Nondiscrimination Act of 2008 (GINA) to address incentives in workplace wellness programs....more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

McGuireWoods LLP on

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

Foley & Lardner LLP

Another Patent Challenge for Personalized Medicine

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The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Foley & Lardner LLP

Privacy Issues in the Sharing of Genetic Information

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Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

Foley & Lardner LLP

Is Next Generation Sequencing Ready for Personalized Medicine?

Foley & Lardner LLP on

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

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