While Senate Minority Leader Chuck Schumer, D-N.Y., has called for an investigation of direct-to-consumer genetic testing companies' privacy policies, the FDA is working on hastening the regulatory approval of DTC genetic testing in order to help expand the testing market. "The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don't fit squarely into our traditional risk-based approach to device regulation," according to a statement released by FDA Commissioner Scott Gottlieb.
Gilead has won a reversal on a ruling for its patent suit with Merck regarding its hepatitis C drugs Sovaldi and Harvoni after US District Judge Leonard Stark of Delaware decided Merck's patent was invalid and didn't fulfill a requirement disclosing how the treatment can be made without undue experimentation. Stark's ruling overturned a jury verdict that had required Gilead Sciences to pay Merck a record $2.54 billion for the patent infringement.
Investigators at the Imperial College London developed a liver-on-a-chip platform capable of hosting the hepatitis B virus. The system, which captured all stages in the hepatitis B virus life cycle, could reduce the costs of drug development, researchers wrote in the journal Nature Communications.
A study in The Lancet Infectious Diseases found the addition of primaquine and methylene blue to antimalarial regimens blocked human-to-mosquito transmission. The midstage randomized study tested four regimens in 80 participants.
Baylor Scott & White Health in Texas has begun a kidney transplant program focused on the needs of Latino communities. The program will offer bilingual education and attempt to increase living donations.
Agios Pharmaceuticals' new-drug application for ivosidenib, which is being developed as a treatment for patients with isocitrate dehydrogenase 1 mutation-positive relapsed/refractory acute myeloid leukemia, was accepted for priority review by the FDA. The PDUFA date for the drug is Aug. 21.
Researchers from the Institut Pasteur-Paris found that gene variations that influence susceptibility to dengue fever and dengue shock syndrome differ among world populations, according to a study in the journal PLOS Neglected Tropical Diseases. "The particular genetic risk conferred by these genes indicates that Southeast and Northeast Asians are highly susceptible to both phenotypes, while Africans are best protected against DSS and Europeans best protected against DF, but the most susceptible to DSS," the study team wrote.
The Department of Veterans Affairs has awarded a five-year contract to Magnolia Medical Technologies to supply the Steripath Initial Specimen Diversion Device for blood culture collection.
Banyan Biomarkers' Brain Trauma Indicator is the first blood test to receive FDA approval to screen for a certain type of brain damage that is usually only detectable with CT scans. The test assesses levels of two proteins, UCH-L1 and GFAP, and it could reduce the need for unnecessary neuroimaging tests and radiation exposure.