Pharma News

The U.S. Food and Drug Administration posted warning letter  issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

We’re excited to partner with HITLAB – a leading NYC-based digital health innovation, teaching, and testing lab – for their upcoming 2019 HITLAB Innovators Summit: India on February 16,  at IIT Delhi.

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

Exposure to uncomfortable sensations elicits a wide range of appropriate and quick reactions, from reflexive withdrawal to more complex feelings and behaviors. To better understand the body’s innate response to harmful activity, researchers at the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, have identified activity in the brain that governs these reactions.

Reductions in malaria cases have stalled after several years of decline globally, according to the new World malaria report 2018. To get the reduction in malaria deaths and disease back on track, WHO and partners are joining a new country-led response, launched today, to scale up prevention and treatment, and increased investment, to protect vulnerable people from the deadly disease.

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

By combining two imaging modalities — adaptive optics and angiography — investigators at the National Eye Institute (NEI) can see live neurons, epithelial cells, and blood vessels deep in the eye’s light-sensing retina. Resolving these tissues and cells in the outermost region of the retina in such unprecedented detail promises to transform the detection and treatment of diseases such as age-related macular degeneration (AMD), a leading cause of blindness among the elderly. NEI is part of the National Institutes of Health, and the paper was published online in Communications Biology. The study was funded by the Intramural Research Program at the NEI.

The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible.

The aim is this: by doing a single study to help establish a non-animal based model, it can potentially replace much of the need to use dogs in future trials with new informatics tools. The  goal is to do one single study involving a small number of dogs—where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial—to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.