News Wire

Positive results have been reported from a phase 3 study of the investigational medication cannabidiol (Epidiolex, GW Pharmaceuticals) in patients with Dravet syndrome, a rare and debilitating type of infantile-onset epilepsy for which no treatments are currently available in the U.S. Cannabidiol achieved…
Across the country, more than 50 rural hospitals have closed during the last six years, and another 283 are in fragile financial condition, according to Kaiser Health News. With rural populations long in decline in the U.S., small-town hospitals have lost customers and struggled to keep pace with advancements…
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has announced that it will discuss the new drug application for eteplirsen (Sarepta Therapeutics) on April 25––nearly three months after the original action date. Sarepta is seeking approval for the treatment of Duchenne…
A genetically engineered mosquito being used in the fight against the Zika virus will not have a significant impact on the environment, according to preliminary findings from the FDA. Males of the self-limiting strain of the Aedes aegypti mosquito are modified so that their offspring die before being…
A phase 3 monotherapy study has met its primary endpoint, demonstrating that sarilumab (Regeneron Pharmaceuticals/Sanofi) was superior to adalimumab (Humira, AbbVie) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at week 24. The study, SARIL-RA-MONARCH, also met important…
The FDA has accepted for review a supplemental biologics license application (sBLA) for the expanded use of etanercept (Enbrel, Amgen) to treat pediatric patients with chronic severe plaque psoriasis. If approved, etanercept would be the first systemic drug with this indication in the U.S. The sBLA,…
An investigation into a clinical test in France that left one person dead and put five others in a hospital has found evidence of brain damage in people who took high doses of the experimental pain medicine, according to a report from NPR News. The early-stage clinical study was shut down in January…
Two widely used targeted-therapy drugs approved by the FDA for the treatment of metastatic kidney cancer—sorafenib (Nexavar, Bayer/Onyx Pharmaceuticals) and sunitinib (Sutent, Pfizer)—are no more effective than a placebo in preventing return of the disease, according to a new study from the Abramson…
Positive results have been announced from a phase 2b trial of ixmyelocel-T (Vericel Corporation) in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The study met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations,…
Researchers at Merck have found a way to return antibacterial efficacy to agents that have lost their ability to kill certain types of bacteria. In a paper published in Science Translational Medicine, the team describes a search for molecules capable of interfering with one of the main defense mechanisms…
Large health systems and hospital operators are reporting sliding profits, revenue, and income because of value-based care, according to an article posted on the HealthLeaders Media website. A turnaround is expected, however, once the industry more fully adopts the value-based model. Kaiser Foundation…
Experts on the Zika virus outbreak have agreed on three top priorities for research into medical products, the World Health Organization (WHO) has reported. The WHO warned, however, that vaccine trials may come too late for the current outbreak. The top research priorities are: 1) tests for other viruses,…
Medicare plans to test new ways to pay for prescription drugs given in doctors’ offices and hospital outpatient centers, according to a report from Kaiser Health News. Under a two-part proposal, regulators aim to reduce what some economists and policy experts say are financial incentives for doctors…
Cepheid has received clearance from the FDA to market Xpert Carba-R, a qualitative in vitro diagnostic test for rapid, accurate, and reproducible identification of five distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including…
The U.S. Preventive Services Task Force (USPSTF) is seeking comments on a draft recommendation statement on screening for latent tuberculosis infection (LTBI) in adults. The task force recommends screening for LTBI in adults at increased risk. The USPSTF last issued a recommendation on screening for…

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