Pharma News

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults: Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them; Complicated intra-abdominal infection; Hospital-acquired pneumonia, including ventilator associated pneumonia; Bacteria in the blood associated with any of the infections listed above; Infections due to aerobic Gram-negative organisms in adults with limited treatment options.

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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.

The U.S. Food and Drug Administration approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

National Institutes of Health scientists and their colleagues have found evidence of the infectious agent of sporadic Creutzfeldt-Jakob disease (CJD) in the eyes of deceased CJD patients. The finding suggests that the eye may be a source for early CJD diagnosis and raises questions about the safety of routine eye exams and corneal transplants. Sporadic CJD, a fatal neurodegenerative prion disease of humans, is untreatable and difficult to diagnose.

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.