Pharma News

Researchers have identified ketamine-induced brain-related changes that are responsible for maintaining the remission of behaviors related to depression in mice — findings that may help researchers develop interventions that promote lasting remission of depression in humans. The study, funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health, appears in the journal Science.

The U.S. Food and Drug Administration granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.

EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care.

Children are more likely to be overprescribed antibiotics for colds, sinus infections and sore throats during telemedicine visits than during in-person visits to primary care providers or urgent care facilities, suggests a study funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The study, conducted by Kristin Ray, M.D., of the University of Pittsburgh School of Medicine and colleagues, appears in Pediatrics.

The National Pharmaceutical Pricing Authority (NPPA), under Ministry of Chemicals & Fertilizers, today put out list of 390 anti-cancer non-scheduled medicines with MRP reduction up to 87%.  The revised prices would come into effect from 8th March, 2019.

With the increasing threat of antibiotic resistance, there is a growing need for new treatment strategies against life threatening bacterial infections. Researchers at Lund University in Sweden and the University of Copenhagen may have identified such an alternative treatment for bacterial meningitis, a serious infection that can lead to sepsis. The study is published in Nature Communications.

U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients’ responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients.

The U.S. Food and Drug Administration is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

The biomolecule ribonucleic acid (RNA) is pivotal to cell function. RNA plays various roles in determining how the information in our genes drives cell behavior. One of its roles is to carry information encoded by our genes from the cell nucleus to the rest of the cell where it can be acted on by other cell components. Thanks to a program supported by the National Institutes of Health, researchers have now defined how RNA also participates in transmitting information outside cells, known as extracellular RNA or exRNA.