In case you missed them, we've compiled the top 5 articles from this past week.
“Innovation drives progress,” according to the US Food and Drug Administration (FDA). Innovation is desperately needed in order to develop new agents and therapeutic biological products that could help those in need.
There have been many agents that the FDA has proved as safe and effective over the years, but a comprehensive database consisting of that information did not exist—until Michael S. Kinch, PhD, and his colleagues, who, set out to catalog every drug ever approved by the FDA. They ended up producing “the most comprehensive database in existence.” Not even the FDA had such an archive, and thus, its creation sparked dozens of academic papers and even a book.
Read more about the challenges and advancements associated with vaccine-preventable diseases, here.
Janssen Pharmaceuticals has announced that their phase 3 AMBER study has achieved its primary endpoint, which focused on virologic response rate. The investigational darunavir-based single tablet regimen (STR) has proved to be “non-inferior” to darunavir/cobicistat (D/C) plus emtricitabine and tenofovir disoproxil fumarate (F/TDF) in HIV-1-positive adults without previous treatment.
The safety and efficacy results of the 48-week phase 3 “randomized, double-blind, active-controlled, international, multi-center, non-inferiority study” will be presented this week at the 16th European AIDS Conference, being held in Milan, Italy, according to the press release.
Read more about the darunavir-based regimen, here.
Earlier this summer, it was announced that a team of Canadian researchers led by virologist David Evans, PhD, had successfully synthesized the horsepox virus. This de novo synthesis was performed within the span of 6 months, utilizing mail-order DNA, $100,000, and “little-specialized knowledge.” What is concerning about this experiment is that it highlights not only the possibility of synthesizing DNA with limited resources in a short window of time but that it involved an orthopoxvirus, horsepox, a close relative of smallpox. This experiment has brought attention not just to the capacity and capabilities for people to do such experiments but also that there were little oversight and safeguards in place to ensure biosecurity and biosafety measures were followed. I will not go into the implications of publishing such methods.
Gregory Koblentz, PhD, MPP, director of George Mason University’s Biodefense graduate program, recently highlighted this experiment as a possible opening of Pandora’s box in terms of such risky research and what it means for the reemergence of smallpox.
Read more here.
More information continues to be revealed about the Zika virus as research on a vaccine continues to advance as well. To this end, Penn Medicine investigators recently announced that they have engineered a synthetic DNA-based Zika vaccine able to safely and effectively induce an immune response against the virus, as investigators from the London School of Hygiene & Tropical Medicine have discovered that surveillance for adverse pregnancy outcomes after a Zika outbreak may need to be longer than initially thought.
In the case of the Zika vaccine, investigators from the Perelman School of Medicine at the University of Pennsylvania, in partnership with investigators from the Wistar Institute, Inovio Pharmaceuticals, and GeneOne Life Science, Inc, recently conducted a phase 1 clinical trial that showed “for the first time that humans who received up to 3 doses of a vaccine candidate produced an immune response against Zika with minimal adverse effects, opening the door to further clinical trials for this important vaccine candidate,” according to an official press release on the project.
Read more about the recent Zika studies, here.
Over the last few years there have been several high-profile outbreaks of a particular infectious disease: Legionnaires.'
Although the disease was first described over 40 years ago, in a recent ID Week 2017 presentation, Laura Cooley, MD, MPH, from the Respiratory Diseases Branch of the Centers for Disease Control and Prevention (CDC), referred to it as an emerging disease in the sense that the number of recorded cases of Legionnaires’ in the United States continues to increase.
Why the increase? Dr. Cooley admitted that a solid answer remains elusive, but she postulated that it’s probably multifactorial. “There is definitely an increase in the susceptibility of the population in the United States. The population is aging, and there are more and more people on immunosuppressive medications,” Dr. Cooley shared.
She also pointed out that there could be more Legionella in the environment—with warmer temperatures making a great habitat for bacterial growth. Aging infrastructure could also encourage biofilm and Legionella growth. Dr. Cooley pointed out that improved diagnostic capabilities with the introduction of the urinary antigen test (UAT) for respiratory infections could also be a contributing factor; however, she feels it’s more so that “more clinicians are aware that this is a problem” thanks to the large outbreaks that have sprung up over the past years.
Read more about Legionnaires' disease, here.