Breaking news: FDA issues CRL for Remoxy, cites inconsistencies in its drug release performance
June 28th 2011Pfizer?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.
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Breaking news: FDA calls for changes in ESA dosing for patients with chronic kidney disease
June 28th 2011FDA 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.
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Crizotinib shows early promise as treatment for ALK+ NSCLC
June 24th 2011Crizotinib 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.
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FDA warns of adverse cardiovascular events associated with varenicline, notes label change
June 24th 2011Safety 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.
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Chief actuary for CMS exposes impact of political agendas on healthcare
June 24th 2011Rick 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.
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CDER to transition Office of Compliance to Super Office
June 17th 2011The 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.
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BUD/FORM maintenance and reliever therapy effective asthma control
June 17th 2011Budesonide/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.
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Drug products recalled for possible penicillin cross-contamination
June 17th 2011Aidapak 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.
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Show Coverage: Cooperative behavior is contagious
June 17th 2011Three 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.
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Show Coverage: Health plans must be resilient
June 16th 2011Health 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.
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Show Coverage: Healthcare costs drain the nation
June 16th 2011Policymakers 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.
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Show Coverage: Align products with care models
June 16th 2011Providing 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.
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Show Coverage: Affordability still the sticking point
June 16th 2011The 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
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Show Coverage: Exchanges require ambitious infrastructure
June 15th 2011Heads 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.
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