The UK National Health Service (NHS) has launched its first multi-gene test for cancer patients using next-generation sequencing technology. Researchers at the University of Oxford and Oxford University Hospitals NHS Trust said that the 46-gene test “heralds the arrival of genomic medicine, with whole-genome sequencing of patients just around the corner.”
Almost half of U.S. parents say they won't have their teenage daughters vaccinated against the human papilloma virus (Pediatrics 2013;131:645–51). The percentage of parents opposing the vaccine climbed from 40% in 2008 to 44% in 2010. “HPV causes essentially 100% of cervical cancer,” noted senior author Robert Jacobson, MD.
The U.S. Food and Drug Administration (FDA) “has yet to receive an application for a biosimilar or interchangeable product, but we know there is much industry interest in them,” FDA Director Margaret Hamburg, MD, told the Massachusetts Biotechnology Council on March 15 in Boston. “As of yesterday, FDA's drugs center had received 51 requests for meetings on 12 different biological products, it had held 38 initial meetings with potential sponsors, and had received 15 Investigational New Drug applications for biosimilar development programs.”
If the FDA uses its Accelerated Approval process correctly, “there will be drugs that have to come off the market,” commented Richard Pazdur, MD, director of the agency's Office of Hematology and Oncology Products, during a session about regulatory affairs at the American Association for Cancer Research Annual Meeting 2013 in Washington, DC, April 6–10.
Around the world, nearly 28,000 principal investigators ran clinical studies in 2012, with 61% of them based in North America, down from 84% in 1996, said an analysis from the Tufts Center for the Study of Drug Development in Boston, MA.
Of the 13 anticancer drugs the FDA approved in 2012, “only 1 may extend life by more than a median of 6 months,” noted Ezekiel Emanuel, MD, and 21 coauthors in a March commentary in the New York Times. “All cost more than $5,900 per month of treatment.”
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