News & Analysis as of

Genetic Markers

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Genetics a Likely Factor in Variability of Outcome Following Concussion

by Downs Rachlin Martin PLLC on

Most experts in traumatic brain injury (TBI) agree that there is a high degree of variability in outcomes after TBI, including concussions (usually characterized as “mild” TBIs – mTBI.) In other words, this injury is...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

by Foley & Lardner LLP on

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Privacy Tip #38 – Genetic Privacy and the Use of Genomic Information

Genetic information is basically one’s DNA sequence, which includes health information and genetic information about the individual and their family. It is at the core of one’s individual privacy, as well as providing...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

by BakerHostetler on

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

Health Alert (Australia) - May 25, 2015

by DLA Piper on

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports: Australian Medical Association (AMA) - 19 May 2015 - $19 billion pharmacy deal sign of skewed health...more

A Genetic Basis for Beak Diversity in Darwin's Finches

One of the most iconic observations in biology is Charles Darwin's study of the finches of the Galapagos Islands, and his realization that they had all arisen from the same ancestral bird population. While pigeon breeding...more

What Does President Obama's $215 Million "Precision Medicine Initiative" Mean for Genetic Privacy?

by Foley & Lardner LLP on

We have all heard about the burgeoning opportunities tied to the development of precision medicine (also called “personalized medicine”), which includes the use of an individual’s genetic information to design targeted...more

President Obama Revisits Interest in Personalized Medicine

by Foley & Lardner LLP on

President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported...more

Canada Joins the Gene Patenting Debate

by Foley & Lardner LLP on

Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal...more

Good News, Bad News and More Inflammatory Rhetoric in Myriad Genetics Case

While the rest of the patent world was focused on Supreme Court opinions (issued and pending) and Congressional action vel non on threats like patent trolls, the consolidated Multi District Litigation between Myriad Genetics...more

Six Hot Opportunities in Genomic Medicine

by Foley & Lardner LLP on

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more

Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...more

Personalized Medicine: An Industry Report

by Foley & Lardner LLP on

Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more

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