DNA methylation loss, which can lead to increased transcription, is a frequent feature of cancer cells. Now, researchers have published a paper in the April 2, 2018, issue of Nature Genetics that demonstrates that such methylation loss occurs in almost all normal tissues as well, and that it can be used as a "mitotic clock" to estimate how often a cell has replicated.
Bigfoot Biomedical Inc. has closed a $55 million series B round – providing enough runway, the company said, to bring two diabetes products to market. In 2020, Bigfoot will submit FDA applications for both its infusion pump-based closed loop automated insulin delivery system, known as Bigfoot Loop, and its connected insulin pen-based system, known as Bigfoot Inject. To get there, development must be completed in the next year. It will then seek IDE approvals for pivotal trials to be conducted in 2019. The strategy now is to line up the products, data and approvals that will get all the way to FDA commercialization in 2020.
Reaching across disciplinary and institutional boundaries isn't necessarily a strength of academics at elite institutions such as Harvard University. Concern about precisely that issue nearly undid the founding of the Wyss Institute for Biologically Inspired Engineering before it was even launched at Harvard in the beginning of 2009.
Recognizing dementia and Alzheimer's disease (AD) at an early stage is difficult to do. But that presymptomatic window, before obvious cognitive changes are evident, is thought to be the most effective time to prevent or treat disease. In fact, the FDA recently issued an update guidance advising drug companies to focus specifically upon that presymptomatic period.