News Wire

A study conducted at the University of Helsinki in Finland has detected genetic material from the Zika virus in blood samples obtained from a pregnant woman weeks after the acute rash caused by the infection had passed. At this early stage of fetal development, severe brain abnormalities can be detected…
The FDA has granted marketing approval for defibrotide sodium (Defitelio, Jazz Pharmaceuticals) 80 mg/mL for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic…
In a multicenter, randomized clinical trial, former prisoners who received six monthly injections of extended-release naltrexone (Vivitrol, Alkermes, Inc.)––a medication that blocks opioid receptors in the brain––were significantly less likely to resume opioid use than were those who received…
The diabetes drug pioglitazone (Actos, Takeda Pharmaceuticals) is associated with an increased risk of bladder cancer, according to a study published in the British Medical Journal. The findings suggest that the risk increases with increasing duration of use and dose. No increased risk was seen for…
In response to an epidemic of opiate addiction, hospitals in northern North Jersey are substituting powerful pain medications with a variety of alternatives to prevent patients from getting hooked, according to a report posted on the NorthJersey.com website. Patterns of prescribing are changing for…
The FDA’s Psychopharmacologic Drugs Advisory Committee has recommended the approval of pimavanserin (Nuplazid, Acadia Pharmaceuticals) for the treatment of psychosis related to Parkinson’s disease (PD). The panel voted 12 to 2 that the drug’s benefits outweigh its risks. Currently, no drugs are…
Many of the approximately 15.5 million Americans with coronary heart disease will receive new advice regarding whether and how long to take aspirin combined with another blood-thinning antiplatelet to prevent clotting under updated guidelines released by the American College of Cardiology (ACC) and…
The FDA has issued a complete response letter (CRL) in reply to a new drug application (NDA) for calcifediol modified-release capsules (Rayaldee, Opko Health) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage-3 or -4 chronic kidney disease (CKD) and vitamin D insufficiency.…
Promising results from a phase 2 study of AC6 gene transfer for the treatment of patients with heart failure and reduced ejection fraction have been published in JAMA Cardiology. The findings indicate that, through one-time administration, AC6 gene transfer safely increased heart function beyond optimal…
Eight out of ten pain patients feel hospital staff members have not been adequately trained in pain management, and more than half rate the quality of their pain care in hospitals as poor or very poor, according to a new survey from Pain News Network . More than 1,250 acute and chronic pain patients…
The FDA has approved a supplemental new drug application for Stiolto Respimat (tiotropium bromide/olodaterol inhalation spray, Boehringer Ingelheim) that adds data showing improvement in health-related quality of life among patients with chronic obstructive pulmonary disease (COPD) to the product labelling.…
Scientists at the Icahn School of Medicine at Mount Sinai compared basic blood tests run by commercial laboratories and found that the testing service and the time of collection significantly influenced results. Given that lab tests are used to help decide everything from disease diagnosis to whether…
The FDA has issued a complete response letter (CRL) in reply to a supplemental new drug application requesting permission to include new data in the clinical trials section of the U.S. label of vortioxetine (Brintellix, Takeda/Lundbeck) for treating certain aspects of cognitive dysfunction in adults…
A new analysis of the prehistoric origin of malaria suggests that it evolved in insects at least 100 million years ago, and that the first vertebrate hosts of the disease were probably reptiles, which at that time would have included dinosaurs, according to a report from Oregon State University (OSU).…
The FDA has denied Eagle Pharmaceuticals’ request for seven years of orphan drug exclusivity in the U.S. for Bendeka, a liquid, low-volume (50 mL), 10-minute infusion formulation of bendamustine hydrochloride. Bendeka was approved in December 2015 for the treatment of patients with chronic lymphocytic…

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