Pfizer?s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker?s abuse-resistant products ? immediate-release Oxecta (oxycodone HCl) ? for the management of acute and chronic moderate-to-severe pain.
FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.
Crizotinib demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer with an anaplastic lymphoma kinase positive genetic alteration, according to the results of a study presented at the annual meeting of the American Society of Clinical Oncology.
Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
FDA announced reports of medication errors involving risperidone and ropinirole in which some patients who took the wrong medication needed to be hospitalized.
Study shows that several common antiepileptic drugs pose the risk of major congenital malformations and that risk increases dose-dependently.
FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.
The Healthy Steps kiosk provides health tips for travelers, nutrition information for meals on the go, videos and a feature that shows the distance traveled and calories burned by walking to different points in the airport.
Humana Inc. has formed an alliance with Allscripts to provide eligible physician practices with incentives for implementing electronic health record (EHR) technology.
Rick Foster, the chief actuary for the Centers for Medicaid & Medicare Services (CMS), detailed the impact of an ever-deepening political divide in his keynote address at the Society of Actuaries' 2011 Health Meeting on June 13.
The Centers for Medicare & Medicaid Services (CMS) has proposed rules that would allow pre-qualified organizations to access Medicare data for the purpose of quality measurement.
The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.
Angiotensin receptor blockers do not increase the risk of developing cancer in patients using the medications, FDA announced recently after a safety review.
Aidapak Services has issued a voluntary recall of a large number of repackaged drug products after learning of the potential cross contamination of non-penicillin with penicillin drug products repackaged in the same facility.
FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.
Three degrees of separation is all it takes to influence good or bad behavior?whether it's making poor health choices or simply being happy, said Nicholas Christakis, MD, professor, departments of Health Care Policy, Medicine and Sociology, Harvard University.
Claims systems must be able to manage bundled payments, David Nace, vice president, medical director, McKesson Health Solutions, told AHIP Institute attendees during his Thursday presentation.
The United States is in a slow recovery from the recession with a modest growth rate of 2% to 3%, according to two former White House economic advisors, speaking on Friday morning.
Health plans must be resilient and look for opportunities to innovate, collaborate and engage in the policy process, according to former U.S. Senate Majority Leader Tom Daschle, who spoke this morning. He advocates for a bipartisan approach.
Policymakers know healthcare spending must be addressed if the nation's economy is to improve. Tim Pawlenty, former governor of Minnesota said leadership is the main ingredient required for making the quantum changes needed to improve the healthcare system.
Healthcare fraud often manifests like a fad, according to Louis Saccoccio, executive director of the National Health Care Anti-Fraud Assn. Saccoccio spoke to the AHIP Institute audience about fraud on Thursday afternoon.
Collaboration is the driving force behind accountable care organizations (ACOs), a strategy that requires a partnership among a diverse set of stakeholders?providers, payers and purchasers.
Providing the right care at the right place at the right time at the right price has plagued the healthcare industry for decades. While the mantra isn?t new, integrating innovative products, reimbursement and the care model holds promise as a solution, said Sam Muppalla, executive vice president, chief strategy and marketing officer, Portico Systems. He spoke during a Thursday presentation on aligning these three elements.
The industry is in an affordability crisis, according to Dan Spirek, executive vice president, chief strategy and marketing officer for TriZetto. He was a speaker during a Thursday presentation on managing post-reform healthcare. While he said that reform has increased access to care, he questioned its role in abating cost trends
Heads up, health plans. If you want to compete in a health insurance exchange, the time to prepare is now, said Sarah Rodehorst, director, government health programs for Atlanta-based Connecture, a Web-based administration solutions company. She co-presented a session on Wednesday on building an infrastructure to meet exchange requirements.
MANAGED HEALTHCARE EXECUTIVE brings you three days of onsite coverage from Institute 2011 in San Francisco, including today's "Preparing for Exchanges" educational conference. Creating strategies to address the emerging exchange models remains a monumental challenge for managed care, and according to experts, the states are taking a variety of approaches.
Health insurance exchanges don?t have to be in place until 2014, but states are quickly gearing up for their launch. Dhan Shapurji, director, Deloitte Consulting, along with two of his colleagues, neatly packaged the challenges facing exchanges into nine operational components:
Rate review under the Patient Protection and Affordable Care Act will take effect September 1, and many states still have a great deal of groundwork to do. States will have the primary responsibility for reviewing rate increases, while the Department of Health and Human Services will serve in a backup role.
An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.
