FDA approves first weight-loss treatment in over a decade
June 28th 2012FDA has approved lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who are overweight or obese and have at least 1 weight-related comorbid condition. It is the first prescription weight-loss treatment approved by FDA in 13 years.
FDA issues complete response letter for ACS indication for rivaroxaban
June 22nd 2012FDA issued a complete response letter regarding a supplemental New Drug Application for rivaroxaban (Xarelto, Janssen Research & Development) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome.
AMCP pleased with revised PDUFA
June 22nd 2012The Academy of Managed Care Pharmacy strongly favors the revisions of the Prescription Drug User Fee Act (PDUFA) that the US House of Representatives and the US Senate conference committee negotiated earlier this week and the House passed by voice vote on Wednesday.
Dabigatran prescribing information is updated
June 22nd 2012Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation.
Ongoing diabetes self-management support study
June 22nd 2012A participant-driven reinforcement program for diabetes self-management education can have a positive effect on self-care behaviors as well as metabolic and cardiovascular health, according to a study published recently in Preventing Chronic Disease.
MTX injection not superior to oral administration in juvenile idiopathic arthritis
June 22nd 2012Injections of methotrexate were not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis, according to a new study, published in the May 30 online edition of Arthritis Care & Research.
Combination therapy more effective than metformin alone for treating youth with type 2 diabetes
June 22nd 2012A combination of 2 diabetes drugs, metformin and rosiglitazone (Avandia, GlaxoSmithKline), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health has found.
New data shows better QOL with enzalutamide for men with advanced prostate cancer
June 15th 2012Men with advanced prostate cancer treated with investigational enzalutamide (formerly MDV3100) demonstrated a significantly higher response rate in health-related quality of life compared with placebo, according to new data from the phase 3 AFFIRM study.
FDA approves pertuzumab for treatment of HER2-positive metastatic breast cancer
June 11th 2012FDA has approved pertuzumab (Perjeta, Roche) in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Intensive blood-sugar control for diabetic patients produces mixed results
June 8th 2012Intensive control of blood-sugar levels among patients with type 2 diabetes mellitus may reduce the risk of microalbuminuria and macroalbuminuria, signs of kidney damage, but evidence is lacking regarding the effect over renal end points, according to the results of a study published May 28 in Archives of Internal Medicine.
Sandoz recalls some lots of generic Introvale due to packaging error
June 7th 2012Sandoz, a division of Novartis, is voluntarily recalling 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) tablets in the United States, after a consumer reported a packaging flaw.
HHS harnesses the power of health data to improve health
June 5th 2012The Health Data Initiative Forum III: The Health Datapalooza cohosted by the Institute of Medicine and the US Department of Health and Human Services (HHS) is convening this week in Washington, DC, focusing on innovative applications and services that harness the power of open data from HHS and other sources to help improve health and healthcare.
Study: Increase in e-prescribing helps adherence, costs
June 1st 2012The number of physicians and clinicians using e-prescribing increased by 67% in 2011 and they filled 75% more medication orders electronically, according to a new downloadable report by Surescripts, which operates a nationwide network connecting the computer systems of physicians and pharmacies.
Folic acid supplementation may lower risk of certain childhood cancers
June 1st 2012Folic acid fortification of US grain products may be lowering rates of certain kidney and brain cancers in children but does not appear to be causing childhood cancer rates to increase, according to findings from a study published online May 22 in the journal Pediatrics.