Pharma News

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme.

In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. NASEM was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence where future research is needed. We greatly appreciate all the work done by NASEM to produce the consensus reportExternal Link Disclaimer released.

Effective treatments for deadly diseases often depend on unlocking the mysteries of how proteins in our bodies behave.

Research at U.S. Department of Energy’s (DOE) Argonne National Laboratory enables these insights, including one breakthrough that led to a promising drug for Ebola.

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.