Pharma News

U.S. Food and Drug Administration authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients.

The U.S. Food and Drug Administration announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released guidance intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Topical Solution USP, 0.05%, the generic version of Temovate® Topical Solution, 0.05%, of Fougera Pharmaceuticals, Inc. This product will be manufactured at Glenmark’s Baddi plant in India.

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Boehringer Ingelheim and Eli Lilly to collaborate with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes. The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU). Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.

Glenmark Pharmaceuticals to initiate Phase 2b clinical trial of GBR 830 (Monoclonal Antibody), a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018.

A Korean research team from KAIST developed a computational framework, DeepDDI, that accurately predicts and generates 86 types of drug-drug and drug-food interactions as outputs of human-readable sentences, which allows in-depth understanding of the drug-drug and drug-food interactions.

Transplanted livers change the profile of blood cells in the recipients, reducing the potential for organ rejection, Mayo Clinic research shows. The findings are published in Kidney International.

Researchers at LSTM's Alistair Reid Venom Research Unit are looking at treatment for snakebite in a completely different way and have shown that it is possible to treat the bite from one snake with antivenom produced from a completely different species that causes the same pathology in humans.

Roche announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.