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DNA Life Sciences Food and Drug Administration (FDA)

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

Sheppard Mullin Richter & Hampton LLP

New State Genetic Privacy Law Directed at Consumer Genetic Tests

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer...more

Womble Bond Dickinson

An Untapped Natural Treasure Trove of Viruses to Treat Drug-Resistant Bacterial Infections

Womble Bond Dickinson on

Phages, formally called bacteriophages — the most abundant, ubiquitous organisms in nature — are viruses that infect, replicate in, and destroy bacteria. These viruses are species-specific, and sometimes infect only certain...more

Womble Bond Dickinson

A Promising Tool for Rapid Diagnosis of Unknown Infections in Body Fluids: Metagenomic Next-Generation Sequencing

Womble Bond Dickinson on

Scientists at the University of California-San Francisco (UCSF) have developed a single test, Metagenomic Next-Generation Sequencing (mNGS), that can rapidly identify infectious microbes in body fluids, increasing the speed...more

Knobbe Martens

Patenting and regulation of methods for creating three-parent babies

Knobbe Martens on

A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more

Bradley Arant Boult Cummings LLP

The Patent Office Clarifies the Ban on Patenting Naturally-Derived Drugs and Other Products

Since the very beginning of America’s revolutionary patent system, inventors in the life sciences have been granted patents for discovering and purifying natural products. It was taken as a given that a purified natural...more

Saul Ewing LLP

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

Saul Ewing LLP on

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

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