FDA has approved changes to the hepatitis C antiviral simeprevir (Olysio, Janssen) label to include new warnings about serious symptomatic bradycardia-slowing of the heart rate-when co-administered with antiarrhythmic drug amiodarone and antiviral sofosbuvir (Solvaldi, Gilead).
The FDA today approved the first generic version of Copaxone (glatiramer acetate injection) for treating patients with relapsing forms of multiple sclerosis (MS) on April 16.
Ibrutinib, a newly approved drug for Waldenstrom’s Macroglobulinemia, a rare form of lymphoma, continued to control the rare blood cancer, with 95% of patients surviving for 2 years, according to a new study, published in The New England Journal of Medicine.
Patients with hereditary angioedema (HAE) are accruing specialty drug treatment costs of more than $300,000 annually on average, according to a study presented at the Academy of Managed Care Pharmacy (AMCP) 27th Annual Meeting and Expo, in San Diego.
BLOG: Pharmacogenomics is the study of how DNA differences affect response to medications. This can explain why similar patients have different reactions to the same medication even if they receive the same dosage. The pharmacogenomics clinic at NorthShore is the first step toward a larger implementation.
New cystic fibrosis treatments, that target the gene mutations causing the disease, will significantly increase healthcare costs, according to a study presented at the Academy of Managed Care Pharmacy (AMCP) 27th Annual Meeting and Expo, in San Diego.
Reducing long-term care utilization among patients with Parkinson’s disease psychosis (PDP) may lower overall economic burden, according to data presented at the American Managed Care Pharmacy 27th Annual Meeting & Expo in San Diego.
Pregnant women are commonly being prescribed opioids - narcotic pain relievers such as hydrocodone - which results in an increased likelihood of neonatal abstinence syndrome (NAS), a drug withdrawal syndrome that opioid-related infants experience shortly after birth, according to a study in Pediatrics.
Onglyza, the diabetes medication manufactured by AstraZeneca, may be associated with an increased death rate, according to a preliminary review by the Food and Drug Administration (FDA).
A Louisiana senator is calling for a closed drug formulary for the state’s Worker’s Compensation program, to help combat the overutilization of opioids and compounded drugs.
Researchers raised concerns about the safety of prescribing combination antihypertensive medications in elderly patients with low blood pressure, in a new JAMA Internal Medicine study.
The pricing of oncology drugs is not necessarily based on their novelty or effectiveness, according to a new JAMA Oncology study. Instead, researchers found, “current pricing models are not rational but simply reflect what the market will bear.”
Patients without insurance could be asked to pay twice as much or more than insurers pay for chemotherapy, according to a study published in he April issue of Health Affairs.
Several weight loss and fitness supplements contain the chemical BMPEA, a stimulant similar to amphetamine, according to a new study.
In a large, mutli-center study, researchers discovered potential biomarkers for accurately assessing idiopathic pulmonary fibrosis (IPF) disease progression. The study, published in the March 11 issue of The Lancet Respiratory Medicine, was led by R. Gisli Jenkins, PhD, with the Division of Respiratory Medicine at the University of Nottingham in the United Kingdom. The PROFILE study was funded by GlaxoSmithKline R & D and the Medical Research Council.
The FDA has approved the Gastric Emptying Breath Test (GEBT), manufactured by Advanced Breath Diagnostics, a new, non-invasive test used to help diagnose gastroparesis.
According to Catamaran's 2015 Informed Trends Report, diabetes accounted for a major share of the increase in traditional drug trend. The study also found that specialty medications accounted for 28% of drug costs but only 1% of claims.
Paracetamol is ineffective in reducing pain, disability or improving quality of life for patients who suffer from low back pain or osteoarthritis of the hip or knee, and its use may affect the liver, according to a study published BMJ.
Antibiotic-resistant methicillin-resistant Staphylococcus aureus (MRSA) exposed to cigarette smoke become even more resistant to killing by the immune system, according to a study published in Infection and Immunity.
Initiating antipsychotics may elevate a child’s risk not only for significant weight gain, but also for type 2 diabetes by nearly 50%, according to a study in JAMA Pediatrics. Moreover, among children who are also receiving antidepressants, the risk may double.
Actavis plc on Friday said it filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) seeking approval to market Ambrisentan Tablets, a generic version of Gilead Sciences, Inc.'s Letairis®, a treatment for pulmonary arterial hypertension.
Patients diagnosed with deep vein thrombosis (DVT) and treated with rivaroxaban (Xarelto) were admitted to the hospital less frequently than those treated with the standard treatment of low-molecular-weight heparin (LMWH) and warfarin, according to real-world data presented at the Hospital Medicine 2015 Congress.
FDA actions in brief, priority review, breakthrough therapy designation, fast-track designations, orphan drug designations, first-time generic approvals
Coverage of specialty pharmaceuticals varies widely among health insurers, according to a new report from Atlantic Information Services in Washington, D.C.
Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.
