Endpoints News – Prepping for a rapid-fire launch, Kite Pharma gets a pass from FDA on axi-cel panel review
The FDA has evidently learned all it wants at this point from its outside oncology experts on CAR-T. Kite Pharma’s closely-watched CAR-T drug axi-cel is getting a pass on an adcomm meeting, which may signal a quick thumbs up from regulators.
GenomeWeb – CDC Awards $201M to Programs Combating Infectious Disease Threats
The US Centers for Disease Control and Prevention (CDC) announced today that it has awarded $201 million to programs to help state and local governments address infectious disease threats using genomics and other technologies.
HawaiiNewsNow – Gabbard: USDA should require clear GMO labeling on all foods
U.S. Rep. Tulsi Gabbard is urging the USDA to make GMO labeling on foods clear -- and universal. The U.S. Department of Agriculture is developing final rules on GMO-labeling requirements, and it's not yet clear what the new rules will entail. Gabbard, D-Hawaii, joined other members of Congress in calling for clear GMO labeling on foods. (Others have critiqued the proposal.)
National Institutes of Health – NIH accelerates the use of genomics in clinical care
The National Institutes of Health (NIH) is awarding $18.9 million towards research that aims to accelerate the use of genome sequencing in clinical care. The new awards will generate innovative approaches and best practices to ensure that the effectiveness of genomic medicine can be applied to all individuals and groups, including diverse and underserved populations, and in healthcare settings that extend beyond academic medical centers.
National Institutes of Health – The All of Us Research Program Initial Protocol
Now that our initial research protocol has been approved by our institutional review board, I’m glad to share the key elements of it with you as an additional source of information about those and other topics, along with some Frequently Asked Questions.
Science – CRISPR patent battle in Europe takes a ‘wild’ twist with surprising player
MilliporeSigma, a subsidiary of pharmaceutical giant Merck KGaA of Darmstadt, Germany, has become a new major player in the complicated European patent battles over CRISPR, the revolutionary genome-editing tool. The European Patent Office (EPO) on 27 July signaled that it intends to grant a patent to MilliporeSigma, which operates in the United States and Canada, for the use of CRISPR to splice genetic information into eukaryotic cells.
Scientific American / Reuters – Gene Therapy Is Now Available, but Who Will Pay for It?
Thanks to advances in delivering genes to targeted cells, more treatments based on fixing faulty DNA in patients are coming soon, including the first ones in the United States. Yet the lack of sales for the two drugs already launched to treat ultra-rare diseases in Europe highlights the hurdles ahead for drugmakers in marketing new, extremely expensive products for genetic diseases.
Managed Healthcare Executive – Health plans explain genetic testing coverage decisions
Today there are nearly 67,000 genetic tests representing nearly 5,000 disorders and 5,900 genes, according to GeneTests, a medical genetics information resource. With so many tests available, it can be difficult for MCOs to determine what to cover.
New Haven Register / The Associated Press – Pfizer to invest $100 million in N Carolina for gene therapy
Biopharmaceutical giant Pfizer Inc. plans to invest $100 million in a North Carolina plant to focus on a process by which genetic material is introduced to counter defective or missing genes. The company confirmed Gov. Roy Cooper's news on Monday that it will expand its Sanford operations in preparation for producing gene therapy medicines based on technology developed at UNC-Chapel Hill. Cooper's news release says the investment will lead to 40 new jobs.
Retraction Watch – Unearthed emails: Monsanto connected to campaign to retract GMO paper
A trove of internal documents from Monsanto, recently unsealed in a lawsuit against the agricultural biotech giant, has revealed the firm’s role in the knotty tale of a paper from the lab of a scientist known for his stance against genetically modified organisms (GMOs).
WIRED – Veritas Genetics Scoops Up an AI Company to Sort Out Its DNA
Sorting all that genetic information out is a perfect task for artificial intelligence. And plenty of AI startups have bent their efforts in that direction. On August 3, sequencing company Veritas Genetics bought one of the most influential: seven-year old Curoverse.
New Scientist – First implants derived from stem cells to ‘cure’ type 1 diabetes
Last week, two people with type 1 diabetes became the first to receive implants containing cells generated from embryonic stem cells to treat their condition. The hope is that when blood sugar levels rise, the implants will release insulin to restore them to normal.
Scientific American – Gene-Editing Success Brings Pig-to-Human Transplants Closer to Reality
Pig organs are similar in size and function to our own, and people are less squeamish about harvesting body parts from an animal raised for meat than they would be about a primate’s. Yet one major hurdle that has continued to vex any such cross-species transplants, or xenotransplants, has been the threat of transmitting viruses that can infect people and pigs alike.
STAT – The creator of the pig-human chimera keeps proving other scientists wrong
Juan Carlos Izpisua Belmonte had spent years probing the inner workings of embryos, ferreting out the genes that give a body its shape or allow wings to form instead of legs. But one thing he never stopped thinking about was how salamanders could lose parts of their bodies and then regrow perfect replacements. Was it possible, he wondered, that humans might do the same?
Medscape – Are Doctors Ready to Counsel on DTC Genetic Testing?
In any event, many more companies are offering services that say, we'll give you health information. The US Food and Drug Administration (FDA) has started to approve some of these tests. I'm worried because I think that when patients get risk factor information about very serious diseases, such as Alzheimer or Parkinson disease, even when they say they can handle that information, they need help. They need counseling.