Patient biomarkers are now used in personalized medicine to predict disease progression, minimize side effects, and maximize therapeutic benefits in the treatment of disease. In oncology, the use of biomarkers has increased...more
On October 24, 2023, the US Patent and Trademark Office (“USPTO”), which is a component of the Department of Commerce, published two notices in the Federal Register seeking input from Tribal Nations regarding intellectual...more
After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more
In this episode of OnAir: Health Care, Akin Gump senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Michael Hund of EB Research Partnership....more
An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more
As gene editing techniques come to the fore in the UK and elsewhere, industry increasingly needs clarity on the breeder's exception to plant variety rights. Originally published on IAM media.com on May 2022....more
In the past several months we have written a couple of times about the world of anonymous parentage and the conflict it has unintentionally ignited. In October we published “23 and EEEEEE” excerpting from the Philadelphia...more
Parkinson’s disease is a devastating, incurable, progressive and degenerative neurological disease that affects movement. There are no biomarkers available and it is diagnosed by symptomology alone. Unfortunately, the...more
The dire wolf (Canis dirus), prototype of the various wolves that were important members of the House Stark family of characters in Game of Thrones, was found uniquely in North America until its extinction in the late...more
Cancer, the "Emperor of All Maladies" as it has been termed, has been studied for millennia. President Nixon's "War on Cancer" resulted in slow but steady progress, aided by the biotechnology revolution, the development of...more
In the last days of the most recent legislative session, the California State Legislature was busy passing several privacy bills set to impact businesses. The most recent, the Genetic Information Privacy Act, would require...more
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the most severe since the 1918 influenza pandemic (colloquially known as the Spanish Flu; see, J. Barry, The Great Influenza: The Story of...more
Genetic instability has long been recognized as a hallmark of oncogenesis and tumor progression. The phenomenon was first identified cytogenetically, most famously by the Philadelphia chromosome in chronic myelogenous...more
Lions (Panthera leo) once were a widely distributed group of terrestrial mammals, ranging during the Pleistocene (from about 2,580,000 to 11,700 years ago) in Eurasia, Africa, and North America, with species that included the...more
As the coronavirus pandemic engulfs us, it is easy to imagine the litigation that may follow—including tort suits seeking damages for illness or death allegedly caused by negligent or reckless exposure. Possible fact patterns...more
The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more
The avocado, having gained popularity (at least in the U.S.) as a convenient (and delicious) vehicle for consuming otherwise not particularly healthful corn chips, has more recently been hailed as a "superfood" when consumed...more
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more
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
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
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
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