The Latest in Research and Policy Developments
Amidst the many terrific events from September's Childhood Cancer Awareness Month, there have also been several important research and policy developments in recent weeks that deserve their own spotlight. Today, we bring you a round-up of items that we're continuing to watch and monitor: Childhood Cancer Research News --
- Neuroblastoma Agent Receives FDA Orphan Drug Designation: MabVax Therapeutics received orphan drug designation for a vaccine designed to elicit a targeted immune response against neuroblastoma cells. The phase I trial demonstrated encouraging outcomes among 15 patients with relapsed neuroblastoma, with a phase II trial expected to take place in 2015. Receiving orphan status from the FDA provides development incentives and market exclusivity for the pharmaceutical company.
- Fertility Risk for Male Childhood Cancer Survivors: Researchers have pinpointed the cumulative chemotherapy dose threshold that poses a risk to future sperm production in male survivors of childhood cancer. Treatment below that threshold is unlikely to impact future fertility. This new information is expected to aid in discussions and decisions about fertility preservation options.
- FDA Awards New Grants for Pediatric Rare Disease Products: The Food and Drug Administration recently awarded 15 new grants to promote the development of device and drug products for patients with rare diseases through the FDA's Orphan Products Grants Program. At least a quarter of the $19 million will go directly to pediatric rare disease research, including childhood cancer. The FDA press release outlines all the new grant recipients and their projects.
Policy News --
- Congress Keeps Government Funded until after Elections: A Continuing Resolution (CR) was passed in September that keeps the government funded at FY2014 levels through December 11th. While the CR prevented a potential government shutdown, the flat funding impacts the National Cancer Institute by restricting new research and growth. We'll be watching the budget situation closely after the mid-term elections when the "lame duck" Congress faces that December CR expiration date. The new Congress will face complex budget challenges next year, including a sequestration threat and the debt ceiling.
- Health Care Challenge Possible as Supreme Court Begins New Term: The Supreme Court kicked off a new term this week with same-sex marriage dominating the headlines, but we're watching closely to see whether the Court will take up a challenge to the Affordable Care Act that could eliminate health insurance subsidies for millions of Americans enrolled in state-run exchanges.
- California Becomes Newest State to Mandate Paid Sick Leave: Beginning in July 2015, employers in California will be required to provide at least three days of paid sick leave annually to employees who work at least 30 days a year. Employees will be able to use the leave to care for themselves or for a sick family member - like a child with cancer. The new law is expected to benefit 6.5 million workers who currently lack paid sick leave, mostly low-wage workers. Although federal legislation has never advanced far in Congress, several other cities and states mandate paid sick leave and it's an issue appearing on some ballot measures this fall. The New England Journal of Medicine recently featured this issue in the perspective piece "Time Off to Care for a Sick Child - Why Family-Leave Policies Matter."
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