News

FDA has approved label update for abiraterone acetate (Zytiga, Janssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

On March 31, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola.

UnitedHealth Group’s announcement that its free-standing pharmacy care services business, OptumRx, will merge with Catamaran Corp., the fourth largest pharmacy benefit manager in the U.S., makes sense, according to industry experts.

The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.

Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to the Food and Drug Administration (FDA) for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.

Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients’ quality of life without causing other adverse health effects, according to a study published in JAMA Internal Medicine.

FDA has approved use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi Pasteur, the vaccines division of Sanofi) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.

The Affordable Care Act’s medical loss ratio provision yielded more than $5 billion in benefits to consumers from 2011 through 2013, either through the rebates that insurance companies have paid to them or through reduced health plan spending on overhead, according to a new Commonwealth Fund report.

Health and Human Services (HHS) recently launched a widespread initiative – including increasing the use of naloxone to reverse opioid overdoses – aimed at reducing prescription opioid and heroin related overdose, death and dependence.

Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.

Both the Food and Drug Administration (FDA) and Harvoni and Sovaldi maker Gilead are warning Hepatitis C patients about serious bradycardia when the drugs are combined with certain other medications.

FDA has approved Anthrax Immune Globulin Intravenous (Human) (Anthrasil, Emergent BioSolutions) also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

Restrictive Medicaid prior authorization policies are leading to substitution of potentially inappropriate, off-label psychotropic medication use and other problems in prescribing antipsychotic medications for children, according to a recent research letter.

New data from Phase III trials showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies improved lung function. Boehringer Ingelheim recently presented the new data on investigational tiotropium delivered via Respimat® inhaler at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas.

Half of all consumers who received advance tax credit subsidies for health insurance in 2014 would have to pay back a portion of them to the Internal Revenue Service (IRS), according to a new analysis by the Kaiser Family Foundation.

On December 22, 2014, Opdivo (nivolumab) was approved by FDA with a breakthrough therapy designation. Nivolumab is the second human programmed death-1 (PD-1) receptor-blocking antibody to gain accelerated approval for treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

Many nonvalvular atrial fibrillation (NVAF) patients at high risk for stroke may be undertreated, according to poster presentation sessions at the American College of Cardiology (ACC) 64th Annual Scientific Session in San Diego, Calif.

Alignment between health plans and physician groups not only serves the patient well but can result in financial benefits and increased market share through improvement in clinical outcomes and enhanced consumer trust.

Prothrombin Complex Concentrate [Human] (Kcentra) is non-inferior and superior to plasma for rapid international normalized ratio (INR) reversal and effective hemostasis in patients needing Vitamin K antagonist (VKA, eg, warfarin) reversal for urgent surgical or invasive procedures, according to a study published in The Lancet. INR is a standardized method of assessing the effects of VKA therapy commonly used by clinicians