A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
Last week marked a major milestone in studying the human genome. Since the early 2000s, the Human Genome Project has published successive versions of their map, or "sequence," of the human genome. While rightfully acclaimed,...more
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more
Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies, Lidings has put together a Legal Digest highlighting the most notable patents disputes in Life...more
No painful procedure or biopsy needed. We can test our blood to diagnose and even predict cancer. The Human Genome Project, a joint effort between the U.S. Department of Energy and the National Institutes of Health, began...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
In 2003, for the first time in history, mankind sequenced an entire human genome. The endeavor – known as The Human Genome Project – took 13 years to complete....more
The use of genome-editing techniques in medical therapies has proved to be a promising development in the treatment of certain diseases, such as cancer, HIV and rare diseases, by genetically altering specific types of cells....more
In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more
On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more
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
FDA Hosts Genome Scientists For Next-Generation Sequencing Conference - Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more
One of the promises of the Human Genome Project was that knowledge of the entirety of the human genetic complement would permit researchers to identify genetic bases for diseases that had been intractable to conventional...more
Since completion of the Human Genome Project, genomic profiling and the related advent of personalized medicine have become a hot topic. Many predicted this new genomic information would lead to targeted drug treatments that...more
One of the consequences of the explication of human genomic DNA by the Human Genome Project and related efforts has been a better understanding of anthropological history, i.e., how the human population has changed...more