News Wire

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 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…
Details regarding a “breakthrough medical discovery” with potential for treating patients with serious bacterial infections were presented on January 11 at the 8th Annual Biotech Showcase in San Francisco, California. Principal investigator Steven Goodman, PhD, an associate professor of pediatrics…
Proton pump inhibitors (PPIs), which are commonly used to reduce acid in the stomach, appear to be associated with an increased risk of chronic kidney disease (CKD), but more research is needed to determine whether PPI use causes kidney damage, according to an article published online in JAMA Internal…
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. Supreme Court has declined to hear an appeal from Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, of a $124 million penalty imposed by South Carolina after a jury found that the company had improperly marketed the antipsychotic medication risperidone (Risperdal) and had concealed…
On January 1, Pfizer raised U.S. prices for more than 100 of its drugs, some by as much as 20%, according to a report from Reuters. The company confirmed a 9.4% increase for its profitable pain medication pregabalin (Lyrica), which generated $2.3 billion in 2014 U.S. sales; a 12.9% increase for its…
Steady reductions in smoking combined with advances in cancer prevention, early detection, and treatment have resulted in a 23% drop in the cancer death rate since its peak in 1991. The drop translates to more than 1.7 million cancer deaths averted through 2012. The new findings are included in Cancer…
The FDA has expanded the labeling for the Animas Vibe insulin pump and continuous glucose monitoring system (Animas Corporation/Johnson & Johnson) to include the management of diabetes in children and adolescents 2 to 17 years of age. The system was originally approved in December 2014 for use in…
CHS-0214 (Coherus BioSciences/Baxalta Inc.), a proposed biosimilar of etanercept (Enbrel, Amgen), has met its primary endpoint in a phase 3, double-blind, randomized, controlled clinical trial. This ongoing, 52-week study is evaluating the efficacy and safety of CHS-0214 compared with etanercept in…
The Centers for Medicare and Medicaid Services (CMS) has issued a final rule regarding the ordering of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), according to a report from FierceHealthFinance. Examples of durable medical equipment include hospital beds, oxygen tents,…
Cancer screening has never been shown to “save lives” as advocates claim, experts argue in the British Medical Journal. This assertion is based on reductions in disease-specific mortality rather than overall mortality, say Dr. Vinay Prasad, an assistant professor at Oregon Health and Science University,…
Positive results have been reported from HBV-23, a phase 3 trial of the investigational hepatitis B vaccine Heplisav-B (Dynavax Technologies Corporation) compared with a currently marketed vaccine, Engerix-B (hepatitis B vaccine [recombinant], GlaxoSmithKline), in more than 8,000 adults 18 to 70 years…
The FDA has approved a new indication for the Omnigraft dermal regeneration matrix (Integra LifeSciences Corporation) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin…

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