Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes -
In November 2023, a class action lawsuit was filed against the genetic testing company, 23andMe. The plaintiffs alleged that a data breach resulted in the unauthorized disclosure of 6.9 million users’ personal and genetic...more
We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more
Valentine’s Day seemed an odd time to report the subject but CNN posted a five minute story provocatively titled as “I Slept with My Half Sibling.” This recounts the story of a Connecticut social worker who had symptoms of a...more
We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more
The Federal Trade Commission and the California Attorney General teamed up against California company CRI Genetics, LLC filing a joint complaint against the company alleging that it engaged in deceptive practices when it...more
We previously reported on the unfortunate data breach suffered by 23andMe last month and its implications. We never imagined how horrible it could be....more
We have posted blogs before on sharing genetic information and the risk associated with the disclosure of such sensitive information. Unfortunately, our concerns have been realized....more
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
Two amici have filed briefs in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") of the decision by the Patent Trial and...more
On June 16, the Federal Trade Commission (FTC) announced an enforcement action against 1Health.io Inc. (“1Health,” also known as Vitagene, Inc.), a genetic testing company that analyzes consumer-provided DNA samples and uses...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more
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
The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...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
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
On April 8, Kentucky Governor Andrew Beshear (D) signed House Bill 502 into law....more
Effective January 1, 2022, California Senate Bill 41, the Genetic Information Privacy Act (GIPA), imposes requirements on the collection, use, and disclosure of genetic data collected or derived from direct-to-consumer...more
Companies collecting consumer DNA for non-medical purposes seem to be playing fast and loose with their customers’ data, according to a well-regarded consumer watchdog. This category of private money makers, which could...more
States continue to enact laws targeting the protection of genetic data with two important developments in California and Florida. California’s Genetic Information Privacy Act (“GIPA”), which came into effect on January 1,...more
I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company. Consumer Reports...more
2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more
The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines. The first such study was published in 2014, when an international...more
The Sunday edition of the Philadelphia Inquirer presented a set of stories which are becoming common in a world where Americans can buy DNA kits at the drug store and begin an online search for their ancestry. The sometimes...more
The advent of technology making feasible elucidation of whole genomic sequencing over the past 30 years has led to reports of many if not most important or interesting animal genomes (including the most celebrated results of...more