In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions," including clear statements of a product's approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable.
Health exchange Covered California said it is the first in the United States to adopt benefit design changes to improve access to high-cost specialty drugs.
FDA has approved the first and only 4-times-per-year schizophrenia drug.
After more than 20 years with America's Health Insurance Plans (AHIP) as president and CEO, Karen Ignagni is leaving the organization to become the CEO of New York-based EmblemHealth.She will replace Frank Branchini effective September 1. Branchini, who has served EmblemHealth and its predecessor GHI as president/CEO for 30 years, will continue as the Chair of the Board of Directors.
Streamlining equipment maintenance and repair processes presents an enormous opportunity for healthcare facilities to reduce expenses associated with outside technicians.
We asked healthcare experts and analysts how the move to value-based care will affect prior authorizations. Here's what they said.
Nonvalvular atrial fibrillation (NVAF) patients taking uninterrupted rivaroxaban or warfarin had a low rate of major bleeding and thromboembolic complications, according to data presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published in the European Heart Journal.
Several changes, from new payment models to the "Cadillac Tax," are impacting the health insurance market.
A Hepatitis C patient is suing Blue Cross because the payer will not cover her Harvoni medication. According to the complaint, filed this week in Los Angeles Superior Court by Shernoff Bidart Echeverria Bentley LLP, Blue Cross has arbitrarily chosen to give the treatment only to those patients suffering from the worst stages of liver damage.
The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
A new health rankings report indicates in which states health plans and health executives encounter the most challenges when caring for seniors.
Medicare beneficiaries with diabetes, high blood pressure or high cholesterol may achieve better health outcomes when using pharmacies that are part of performance-based networks, according to early results of a pay-for-performance program conducted by SCAN Health Plan and Express Scripts.
The population of Americans who spend more than $50,000 per year on prescription drugs grew 63% in 2014, largely driven by hepatitis C and cancer therapies, according to an Express Scripts report.
As managed care and hospital organizations increasingly take on the risk for managing patient populations, it is critical to improve patient engagement and awareness of patient care opportunities beyond the acute care setting, according to the results of a new survey.
Global pharmaceutical manufactures need to invest billions of dollars to prevent antibiotic-resistant “superbugs”, according to Jim O’Neill, an economist leading a UK government review into antimicrobial resistance.
FDA has approved sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics) for the treatment of migraines in pediatric patients.
Optum, the UnitedHealthcare subsidiary appointed to fix HealthCare.gov after its troubled launch, will not rebid for a $40 billion contract.
Working in partnership with Doctor on Demand, Optum’s NowClinic and American Well, UnitedHealthcare is expanding its telemedicine reach to encompass 20 million enrollees.
FDA has approved moxifloxacin (Avelox) for the treatment of patients with plague. Avelox has been approved under the Animal Efficacy Rule, because it was not ethical to conduct human trials.
A large international study, published in Nature Genetics, found that the H58 “superbug” version, which is resistant to multiple types of antibiotics, is now a major global health threat affecting many countries, including Asia and Africa, where typhoid is endemic.
Only 5% of Medicaid-enrolled Americans account for 50% of total Medicaid spending, and the top 1% account for almost 25% of spending, according to a new study from the Government Accountability Office.
Two new polls show majority support for the Affordable Care Act (ACA) including the health insurance tax subsidies now under review by the Supreme Court.
Nearly half of American hospitals aren’t taking key steps to prevent Clostridium difficile infection-despite strong evidence that such steps work, according to a new study published online in Infection Control & Hospital Epidemiology.
Even though e-cigarette smoking is on the rise, wellness programs are not giving smoking cessation nearly enough attention or resources, according to a new HealthMine survey.
Hepatitis C infections are soaring in 4 states because of high rates of opioid abuse, according to a new report from the Centers for Disease Control and Prevention (CDC).
The non-profit Biosimilars Forum was launched in May 2015 to offer credible, sustained, and unbiased education about biosimilars. The founding members of the Biosimilars Forum represent the majority of companies with the most significant US biosimilars development portfolios.
Even though cancer screenings have become more available because of the Affordable Care Act, the percentage of adults getting certain cancer screenings has not increased significantly since 2010.
Oral therapies are revolutionizing the treatment paradigm of multiple sclerosis (MS), offering enhanced dosing and patient compliance, according to new analysis. Frost & Sullivan’s A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market found that recent therapeutic advancements aim at improving the tolerability of existing products, specifically for interferon beta and glatiramer acetate. Developing anti-inflammatory medications has also been a key area of focus.
Antibiotic resistance has grown at an alarming rate over the last few decades. To prevent a post-antibiotic era in which common infections could become lethal, an estimated 20 novel families of antibiotics must be developed in the next 50 years. Political groups in both the U.S. and Europe are each working to promote new development, but there are concerns the results may not come in time.
New data from a fairly sizable, open-label follow-up trial, presented at the 2015 American Transplant Congress (ATC) in Philadelphia, showed a statistically significant 43% relative risk reduction of death or transplant failure in patients receiving the belatacept (Nulojix) FDA-approved dosing regimen.