
FDA approved the Maestro Rechargeable System, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.

FDA approved the Maestro Rechargeable System, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.

The Centers for Disease Control’s new guidance that hospitalized and high-risk patients with unconfirmed but suspected flu should be administered anti-virals without waiting may cause additional medication shortages, according to a pharmacist and professor.

FDA has approved long-acting release (LAR) pasireotide (Signifor, Novartis) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

Health insurer Aetna will increase the minimum hourly wage to $16 an hour and enhance medical benefits to lower out-of-pocket costs for employees, the company announced Monday.

It’s no secret that the compounding industry is under greater scrutiny these days. A number of high-profile cases, including recent deaths linked to outsourced intravenous (IV) compounding at a Texas hospital, have moved patient safety concerns front and center.1 In the wake of ongoing fallout and a 2-year crackdown on compounding centers by FDA, many hospitals are analyzing their current strategy and rethinking the pros and cons of outsourced IV compounding.

FDA has approved gadobutrol (Gadavist, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged younger than 2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It is the first gadolinium-based contrast agent for patients aged younger than 2 years, including term neonates

Afatinib extends overall survival in lung cancer patients whose tumors have the most common epidermal growth factor receptor (EGFR) mutation compared with chemotherapy, according to study results published in The Lancet Oncology from 2 independent phase 3 clinical trials in EGFR mutation-positive patients with metastatic non-small cell lung cancer (NSCLC).

FDA has approved carbidopa-levodopa (Duopa, AbbVie) enteral suspension for the treatment of patients with advanced Parkinson’s disease.

Prostate cancer is the most frequently diagnosed cancer, aside from non-melanoma skin cancer, in men in the United States. According to the American Cancer Society, an estimated 233,000 new cases of prostate cancer and an estimated 29,480 deaths from prostate cancer will have occurred in the United States during 2014. About 60% of all prostate cancer cases are diagnosed in men aged 65 years and older, and 97% of cases occur in men aged 50 and older. The incidence of prostate cancer is 60% higher in African Americans than in whites.

CMS' guidelines are helping Medicare Advantage organizations to develop and implement member rewards programs that improve health and prevent injury and illness.

In a drug safety communication, FDA said that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain drugs when used during pregnancy, but that it lacks adequate studies to change current recommendations.

Arkansas and Iowa, two GOP-led states, have received approval for customized options for Medicaid expansion that include cost-sharing provisions for beneficiaries.

A new Commonwealth Fund study finds that, following implementation of the Affordable Care Act, premiums for employer-sponsored insurance in 31 states grew more slowly than in previous years.

The factor Xa inhibitor edoxaban (Savaysa, Daiichi Sankyo) has been approved by FDA to lower the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

FDA approved a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva, Genentech, a member of the Roche Group) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL).

FDA approved an extended-release oral capsule formulation of carbidopa-levodopa (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories, Inc.) for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

2014 was a good year for health insurers, but there are issues in 2015 that could dramatically disrupt the industry’s recent smooth ride.

The U.S. House of Representatives passed two bills this week affecting employer mandate reforms that are part of the Affordable Care Act (ACA), but one is headed for a veto if it clears the U.S. Senate.

Novartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.

While hepatitis C drugs Solvani, Harvoni, and Viekira Pak have been in the news recently because of their high price tag, and Express Scripts’ and CVS Health’s exclusive agreements with the drugmakers, they are not the only culprits in soaring drug costs.

Close on the heels of Express Scripts’ decision to make AbbVie’s Viekira the exclusive hepatitis C treatment in its formulary, CVS Health said it would make Gilead Sciences’ Harvoni and Sovaldi the exclusive option for patients on its commercial drug list, as well as those on Medicare Part D and Medicaid.

FDA this week granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. Previously, the test was only available for use in certain laboratories, and now can be distributed to emergency rooms, health department clinics, physicians’ offices, and other healthcare facilities.

The share of Americans with high medical costs increased prior to the implementation of the Affordable Care Act, according to a new report from The Commonwealth Fund.

Pharmacies and physicians’ offices across the country are reporting a shortage of Tamiflu to prevent and treat the flu, soon after the Centers for Disease Control (CDC) declared the illness an epidemic. The “epidemic” declaration was made after 21 children died so far this season from complications associated with the flu.

Mirabegron (Myrbetriq), an oral drug approved by FDA in 2012 for treating incontinence, may help control weight by boosting the metabolic abilities of brown fat, a form of fat that can help to expend energy, according to an early phase clinical study.

FDA actions in brief, recommendations for approval, fast-track designations.

Today, rating systems are driving consumer decisions in virtually every U.S. industry. A single “gold standard” for customer ratings has yet to emerge in healthcare, and providers and payers are focusing more than ever before on the customer experience – how patients evaluate everyday interactions with their care and service providers.

About 87% of all enrollees during the first month of open enrollment on healthcare.gov were eligible for financial assistance, compared to 80% during a similar time frame in 2014.

There is plenty of activity already in the hepatitis C market as competition has arrived for 2015, including CVS Health versus Express Scripts and Gilead Sciences versus AbbVie, over FDA-approved hepatitis C treatments. This will have implications for retail prescriptions as well as continuity-of-care programs within non-Medicare accountable care organizations (ACOs) and health systems.

Texas, which has almost 1 million residents in the coverage gap, has inquired about Medicaid expansion, while Arizona faces a renewed challenge to its existing expansion program.