News

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.

FDA has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.

In patients with moderate or worse vision loss at baseline, those treated with aflibercept (Eylea, Regeneron) Injection gained, on average, an additional full line or more on an eye chart when compared to those treated with alternative anti-VEGF therapies, according to a study published in the New England Journal of Medicine.

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.

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.

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.