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 -
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law....more
Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more
After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...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
In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...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
This past Friday, a federal district court held that the mere fact of combining certain natural products – such as isolated, naturally occurring AAV sequences and a heterologous non-AAV sequence – and putting them into a...more
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...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
Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more
Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...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
The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...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
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’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....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
Complex, Customized CRISPR Combo Could Help Patients Cure Their Own Cancer - “In a small phase 1 clinical trial run by PACT Pharma, researchers edited the genes of 16 patients’ immune cells to work against their cancer,...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
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