News Wire

One person has been left brain-dead and five others are in serious condition after participating in a clinical trial in France of an experimental painkiller, Reuters reports. The new drug, made by a Portuguese company, works by targeting the body’s pain-controlling endocannabinoid system, which is…
The FDA has issued a complete response letter to the new drug application (NDA) for drisapersen (Kyndrisa, BioMarin Pharmaceutical Inc.) for the treatment of patients with Duchenne muscular dystrophy amenable to exon 51 skipping. The FDA issues complete response letters to indicate that an application…
A new industry survey from HealthLeaders Media outlines the top challenges providers are facing in the transition to value-based care. This transition is significant both for the magnitude of the task and for health care leaders’ reluctance to make a full commitment to change, the survey results suggest.…
At least 250 people, mostly in the U.S., developed life-threatening “superbug” infections linked to contaminated medical scopes during the past three years — more than previously estimated by federal regulators, according to a new report from the Senate Health, Education, Labor, and Pensions (HELP)…
A new report from business intelligence provider GBI Research states that six pancreatic cancer drugs are expected to gain approval by 2021, all of which have demonstrated significant improvement in progression-free survival and/or overall survival in clinical trials. Market growth is anticipated in…
A long-term follow-up study of chronic heart failure patients treated with cardiac contractility modulation (CCM) has been published online in the International Journal of Cardiology. Those receiving CCM experienced significantly improved long-term survival compared with matched patients who did not…
Positive results from a phase 2 study of enzalutamide (Xtandi, Astellas US/Medivation, Inc.) compared with bicalutamide in patients with metastatic castration-resistant prostate cancer have been published online in Lancet Oncology. The TERRAIN trial enrolled 375 patients in North America and Europe.…
Fifty-five hospitals have filed a lawsuit against the U.S. Department of Health and Human Services in response to Medicare payment reductions under the “two-midnight” rule, according to a report from FierceHealthFinance. According to the controversial rule, “an inpatient admission is generally…
Andy Slavitt, head of the Centers for Medicare and Medicaid Services (CMS), has announced that the agency “has the opportunity” to sunset the meaningful use program in 2016. “Programs designed to improve often distract,” Salvitt said in a public statement. “Done poorly, measures are divorced…
The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has voted 12 to 5 in favor of approving probuphine (Titan Pharmaceuticals/Braeburn Pharmaceuticals), the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction in stable patients receiving 8…
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $5 million in funding for 24 research projects seeking to develop nontraditional therapeutics for bacterial infections to help address the growing health threat of…
The FDA has accepted a new drug application for venetoclax (AbbVie/Genentech/Roche) for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at least one prior therapy, including patients with the 17p deletion genetic mutation. The application was granted a priority review.…
The Centers for Medicare and Medicaid Services (CMS) has announced 121 new participants in Medicare Accountable Care Organization (ACO) initiatives designed to improve the care patients receive in the health care system and to lower costs. Of these organizations, 21 will be the first to join Medicare’s…
The U.S. Preventive Services Task Force has published a final recommendation statement on screening for breast cancer after reviewing the science on the benefits and harms of screening mammography, and after considering the input received from public and health care professionals on its 2015 draft recommendation.…
The drug-development pipeline for Parkinson’s disease (PD) offers a more-promising treatment landscape compared with the current market, according to a report from business intelligence provider GBI Research. Levodopa is currently the gold standard therapy for PD, with other drug classes, including…

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