May 31, 2018 The two-year-old DDF — which is run by venture capital firm SV Health and backed by several big biopharma companies and medical charity Alzheimer’s Research U.K. — is focused on backing groups that discover and develop disease-modifying drugs for Alzheimer’s, which despite decades of research can still only be treated with a … Read more
May 29, 2018 Now, they have found a way to manipulate autophagy to lower the risk of Zika infection in developing fetuses, using one of the world’s best-known drugs: the malaria treatment hydroxychloroquine. The research team discovered that hydroxychloroquine, which is listed as an essential medicine by the World Health Organization (WHO), blocks the transmission … Read more
May 24, 2018 Specifically, the devices will be used at the Scripps Translational Science Institute (STSI), which runs The Participant Center, which aims to enroll diverse populations across the U.S. in the program. STSI will provide Fitbit devices to a representative sample of All of Us volunteers for use in a one-year study, according to a … Read more
May 22, 2018 The MDSAP consortium announced Oct. 31, 2017 it has tweaked the program, in response to comments received from Canadian medical device license holders, by the actions as follows: reducing the total number of tasks; introducing reduction in audit time for manufacturers; reducing the duration of surveillance and re-certification audits; and clarifying the … Read more
May 17, 2018 FDA Commissioner Scott Gottlieb, M.D., is proposing to grant these freedoms to companies that complete a one-time review. In shifting regulatory attention from individual products and onto the companies that make them, the FDA is following the playbook it created for digital health. Both of the approaches loosen regulatory oversight of pre-certified … Read more
May 16, 2018 A new policy from the Senate’s National Defense Authorization Act, which is going through committee, would allow the Pentagon to approve devices and drugs not green-lit by FDA to be used on military personnel “for emergency use.” The plans were first published in November 2017 by Politico. However, Gottlieb (FDA Commissioner) has … Read more
May 10, 2018 As someone who enjoys eating out with my family and picking up the occasional take-out meal, I – like many Americans – want to know what’s in the food I eat. As FDA Commissioner, I also know that more people are eating meals away from home, and our diets are increasingly comprised … Read more
May 08, 2018 Direct-to-consumer (DTC) access to GHR tests is made possible by advances in technology. With a small saliva sample, consumers can retrieve their genetic risk result directly from the test provider’s website. As consumer interest in genetic risk information grows, opportunities are also expanding for the detection of additional genetic conditions and diseases … Read more
May 03, 2018 In a phase 2 trial involving 63 children, Joanne Kurtzberg and her team gave patients an infusion of their own cord blood that had been banked at birth. The doses ranged from 10 million stem cells per kilogram of body weight to 50 million per kilogram. A year later, they found that … Read more
May 01, 2018 According to results published in the British Medical Journal, 57% of indications approved during that period hit the market based on endpoints other than overall survival or improved quality of life. Instead, they won their green lights via “surrogate” endpoints such as tumor shrinkage or progression-free survival. And after a median of five years … Read more