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.
New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in US drug spending in 2014 – a rate not seen in more than a decade, according to Express Scripts 2014 Drug Trend Report.
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
A coalition of stakeholder organizations – including the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) – released a consensus document on the "red flag" warning signs related to prescribing and dispensing controlled substance prescriptions.
Food and Drug Administration (FDA) committees this week voted to approve GlaxoSmithKline and Theravance’s Breo ELlipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for 12 to 17-year-olds.
The FDA warns consumers not to rely on the use of over-the-counter homeopathic therapies for the treatment of asthma. Without appropriate management, asthma could lead to a life-threatening asthma attack. Homeopathic remedies have not be evaluated by the FDA and may interfere with asthma management.
Blue Cross Blue Shield of Michigan's program lowered costs and improved patient outcomes.
In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.
FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of Major Depressive Disorder (MDD) in adults.
Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) appears to reduce the risk of colorectal cancer in most individuals, but a few individuals with rare genetic variants do not share this benefit, according to a study published in the March 17 issue of JAMA.
To address the burden of COPD on hospital expenditures, on October 1, 2014, the Centers for Medicare & Medicaid Services included COPD in its Hospital Readmissions Reductions Program. This inclusion resulted in reduced Medicare reimbursement for hospitals that demonstrate excessive 30-day COPD patient readmission rates.
FDA approved its first treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
The United States Drug Enforcement Administration (DEA) on March 18 issued a nationwide alert about the dangers of fentanyl and fentanyl analogues/compounds.
Premera Blue Cross and Lifewise Health Plan had websites offering protections for affected individuals ready to go the day they announced a breach of up to 11 million records of members, vendors and employees.
Lemtrada (alemtuzumab) received FDA approval on November 14, 2014, under fast track designation, for the treatment of patients with relapsing forms of MS.Due to the safety profile, alemtuzumab should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for MS.
FDA has approved asenapine (Saphris, Actavis) for treatment of manic or mixed episodes of bipolar I disorder in pediatric patients, ages 10 to 17 years old.
Alirocumab (Praluent), a PCSK9 inhibitor, reduced low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy, according to a study published online in the New England Journal of Medicine.
A majority of Americans have compared prices before getting care and most want to do so, but access is still a barrier.
There is widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease or dementia who live at home or in assisted living facilities, according to a new General Accountability Office (GAO) report.
In patients with type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 (DPP-4) inhibitor alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes, according to data published in The Lancet.
Expanding blood pressure screenings to non-primary care settings can help identify more patients with high blood pressure and could contribute to better hypertension control and management, according to a Kaiser Permanente study published in The Journal of Clinical Hypertension.
FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
You’ve considered all the risks posed by the new HIPAA guidelines, but did you include streaming media?
Read what a panel of distinguished industry experts has to say about the increasingly difficult job of managing specialty pharmaceuticals.
Blue Cross Blue Shield of Massachusetts has taken big steps to curb the growing opioid addiction problem.
Many employers that offer generous health insurance packages are not looking forward to 2018, when the so-called Cadillac tax will impose a 40% penalty on high-cost health plans.
Mobile device health apps have the potential to transform healthcare, but their exploding use is also giving rise to new concerns about privacy and security.
Provisions of the Affordable Care Act will cost $142 billion less over the 2016–2025 period than originally estimated by government agencies, due to slower premium growth and changes in enrollment sources.
