Pharma News

U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems.

A new drug that inhibits neonatal seizures in rodent models could open up new avenues for the treatment of epilepsy in human newborns. Researchers have identified that gluconate a small organic compound found in fruit and honey acts as an anticonvulsant, inhibiting seizures by targeting the activity of channels that control the flow of chloride ions in and out of neonatal neurons. A paper describing the research, from an international team of scientists led by Penn State researchers, appears May 15, 2019 in the journal Molecular Brain.

Researchers from two major institutions have developed a new tool with advanced artificial intelligence (AI) methods to predict a woman’s future risk of breast cancer, according to a new study published in the journal Radiology.

The European Commission has approved Dupixent® (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters pertain to companies who jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile. An additional letter outlines a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.

Disparities in health care delivery and health outcomes present distressing challenges to underserved populations, who often experience a greater burden of chronic diseases and are more likely to show signs of poor disease management. Health information technology (IT) tools may serve a vital role in reducing such disparities in the clinical care setting. In the Medical Care June supplement, “Addressing Health Disparities Through the Utilization of Health Information Technology,” authors discuss the potential application of health IT in reducing disparities by increasing access to care, improving quality of healthcare and by promoting better patient-clinician communication.

AbbVie announced that it has resolved U.S. HUMIRA (adalimumab) litigation with Boehringer Ingelheim (BI). Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States.

The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced awards to establish four Cooperative Research Centers (CRCs) focused on developing vaccines to prevent sexually transmitted infections (STIs). The grants, totaling $41.6 million over five years, will support collaborative, multidisciplinary research on the bacteria that cause syphilis, gonorrhea and chlamydia. At the end of the program, each center is expected to identify at least one candidate vaccine ready for testing in clinical trials.