NIH researchers ended a clinical trial after healthy volunteers taking a combination of the HIV drug dolutegravir and the tuberculosis treatment isoniazid-rifapentine had "unexpected and serious toxicities," according to a report in the journal Clinical Infectious Diseases. Two of four participants developed influenza-like syndrome and one was hospitalized for a day, and researchers said the drugs should be combined "cautiously, ideally in a clinical research setting."
The American College of Surgeons is calling for teachers to receive "Stop the Bleed" training and for school systems to put stop-bleeding kits in every classroom. Training in basic bleeding-control techniques can save lives, said Dr. Jeff Kerby of the University of Alabama at Birmingham School of Medicine.
The Global Commission to End the Diagnostic Odyssey for Children, formed by Shire, Microsoft and EURODIS Rare Diseases Europe, will form a multidisciplinary group of experts with the goal of expediting the diagnosis of children with rare diseases. "We're seeking innovative ways to integrate emerging technologies into our efforts, which will play a critical role as we strive to impact the diagnosis journey," said Microsoft Chief Medical Officer and Senior Director Dr. Simon Kos.
Celularity, a stem cell startup that collects placenta stem cells for health care products, has raised $250 million. The company is selling wound-healing products and developing immunotherapies.
Three studies in the journal Science detailed how CRISPR gene-editing technology can be used to advance disease detection and treatment. DNA Endonuclease Targeted CRISPR Trans Reporter, or DETECTR, is being developed to identify human papillomavirus strains; SHERLOCK version 2.0 can detect and distinguish Zika or dengue viruses in blood samples; and the CRISPR-mediated analog multi-event recording apparatus, or CAMERA, is being developed to make cells record exposure to pollutants.
A study in the journal Cell Reports described how scientists found the Pi4Ka gene played an important role in blood cell development but can also lead to forms of hematologic malignancy and anemia when disrupted.
In Angola and the Democratic Republic of the Congo, fractional doses of yellow fever vaccine stretched the supply and allowed more people to be vaccinated. Researchers reported in The New England Journal of Medicine that the smaller doses resulted in high rates of immune response.
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.