News

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.

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.

The findings of a new research report from Express Scripts on the use of prescription opiates in the United States indicate that physicians are being more cautious about prescribing pain medications.1 The report shows both a drop in the short-term use of opioids and stabilization in the number of patients using these medications longer term.

After 15 children died from complications associated with the flu this season, the Centers for Disease Control and Prevention (CDC) declared the illness an “epidemic.”

Desert Hospital Outpatient Pharmacy is an independent pharmacy inside Desert Regional Medical Center, a 387-bed tertiary acute care hospital located in Palm Springs, California. Desert Regional Medical Center, which has attained the Joint Commission’s Gold Seal of Approval for its congestive heart failure program, has reduced readmission rates by 17% among congestive heart failure (CHF) patients through a close partnership with Desert Hospital Outpatient Pharmacy.

FDA's approval of a new non-opioid painkiller injection expected to help in the fight against prescription painkiller abuse.

FDA approved the New Drug Application (NDA) for a new treatment for moderate to severe dementia in Alzheimer’s patients.

FDA issued an Emergency Use Authorization (EUA) for LightMix Ebola Zaire rRT-PCR Test for Ebola disease. The test can be used in West Africa and the United States.

The Centers for Medicare and Medicaid Services announced that it has selected Accenture Federal Services for a five-year, $563 million contract to continue Accenture’s work on the federally facilitated marketplace in support of healthcare.gov.

A weeklong test of the ICD-10 coding system by 500 providers resulted in a 76% acceptance rate, according to CMS.

The German Breast Group (GBG) said nab-paclitaxel (Abraxane) demonstrated significant benefit for patients with early high risk breast cancer when compared to conventional solvent-based paclitaxel, according to data presented at the 2014 San Antonio Breast Cancer Symposium, December 9-13 in San Antonio, Texas.

The use of new oral anticoagulants (NOACs) continues to increase. Over the past 4 quarters, rivaroxaban (Xarelto, Bayer/Johnson & Johnson) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) were in the top 20 of fastest-growing drugs in the United States. They offer advantages compared to warfarin such as a rapid onset of action, no dietary modifications, fewer drug–drug interactions, and do not require routine coagulation monitoring.

FDA has approved the new drug application (NDA) for liraglutide [rDNA origin] injection (Saxenda, Novo Nordisk) , the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

A majority of opioid users are taking the painkillers concurrently with other prescription drugs, according to a report from Express Scripts that analyzed US opioid trends.

Cigna/Safeway study finds that patients make cost-conscious choices when provided with education and online shopping tools