Pharma News

The U.S. Food and Drug Administration announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD.

Researchers at Children's Medical Center Research Institute at UT Southwestern (CRI) have uncovered why certain melanoma cells are more likely to spread through the body. The discovery opens up a potential new avenue of treatment and could be used to help reduce the proportion of patients who progress from stage 3 melanoma to more-deadly stage 4 cancer.

Using lipidomics, a technique that measures the composition of blood lipids at a molecular level, and machine learning, researchers at Lund University in Sweden have identified a blood lipid profile that improves the possibility to assess, several years in advance, the risk of developing type 2 diabetes. The blood lipid profile can also be linked to a certain diet and degree of physical activity.

Blood contains hundreds of different lipid molecules that are divided into different classes, such as cholesterol and triglycerides.

Researchers from the University of Copenhagen have succeeded in extracting a complete human genome from a thousands-of-years old "chewing gum". According to the researchers, it is a new untapped source of ancient DNA.

Caption : During excavations on Lolland, Denmark, archaeologists have found a 5,700-year-old birch pitch. Researchers from the University of Copenhagen have succeeded in extracting a complete ancient human genome from the pitch seen in the photo. Credit  Photo: Theis Jensen.

During excavations on Lolland, archaeologists have found a 5,700-year-old type of "chewing gum" made from birch pitch. In a new study, researchers from the University of Copenhagen succeeded in extracting a complete ancient human genome from the pitch.

The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

Researchers at the National Eye Institute (NEI) are launching a clinical trial to test the safety of a novel patient-specific stem cell-based therapy to treat geographic atrophy, the advanced “dry” form of age-related macular degeneration (AMD), a leading cause of vision loss among people age 65 and older. The geographic atrophy form of AMD currently has no treatment.

The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.

Scientists have developed a new gene-therapy technique by transforming human cells into mass producers of tiny nano-sized particles full of genetic material that has the potential to reverse disease processes.

University of Houston associate professor of pharmacology Bradley McConnell is helping usher in a new age of cardiac pacemakers by using stem cells found in fat, converting them to heart cells, and reprogramming those to act as biologic pacemaker cells. He is reporting his work in the Journal of Molecular and Cellular Cardiology. The new biologic pacemaker-like cell will be useful as an alternative treatment for conduction system disorders, cardiac repair after a heart attack and to bridge the limitations of the electronic pacemaker.

Novartis announced topline results from its pivotal global Phase III LUSTER-1 and LUSTER-2 studies exploring the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039). The pooled analyses of the LUSTER trials did not meet the clinically relevant threshold for reduction in rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450 mg). The studies included patients who had inadequately controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller. The totality of these results do not support further development of fevipiprant in asthma.