Rivaroxaban: a novel oral factor Xa inhibitor to prevent stroke in nonvalvular atrial fibrillation
July 1st 2011Rivaroxaban is an oral, direct factor Xa inhibitor under review by FDA for stroke prevention in patients with atrial fibrillation. Atrial fibrillation conveys a 5-fold increased risk for stroke.
Read More
Adoption of evidence-based therapies associated with increased survival of STEMI patients
July 1st 2011In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More
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.
Read More