News & Analysis as of

Human Genes Clinical Trials

Hogan Lovells

How to navigate gene editing regulatory hurdles: FDA webinar clarifies newly finalized guidance

Hogan Lovells on

Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials...more

Manatt, Phelps & Phillips, LLP

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

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...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

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

Hogan Lovells on

The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Goodwin

Safety First! Much-Anticipated FDA Draft Guidance Provides Additional Advice on the Development of Human Genome Editing Products

Goodwin on

Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more

Goodwin

An Overview of the Latest Human Genetic Resources Regime in China

Goodwin on

On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Foley & Lardner LLP

Keeping Up To Date On CRISPR – July 2016

Foley & Lardner LLP on

CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on CRISPR. ...more

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