FDA 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.
FDA has approved gabapentin enacarbil (Horizant, GlaxoSmithKline and XenoPort) extended-release tablets for the management of postherpetic neuralgia in adults.
The Centers for Medicare and Medicaid Services is partnering with providers, caregivers, and patients to ensure appropriate use of antipsychotic medications for nursing home patients, the government announced last week.
The Centers for Disease Control and Prevention is proposing an expansion of its current hepatitis C risk-based guidelines to include a simple, one-time blood test for anyone born from 1945 through 1965.
Sandoz, 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.
The 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.
Legislation to reauthorize FDA user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about 2 weeks to hash out the final language.
Statin therapy is safe and effective for people at low risk of major vascular events and, therefore, current guidelines might need to be reconsidered, according to a study published online in The Lancet.
More than a third of patients newly diagnosed with type 2 diabetes mellitus did not receive the recommended first-line drug, a finding that could have substantial implications for healthcare spending, according to a study published in the American Journal of Medicine.
New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.
FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.
Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)
Recent FDA action (through May 2012) related to, Loxapine, Adasuve, Alexza Pharmaceuticals, Denosumab, Xgeva, Amgen, Furiex, Takeda, Nesina, alogliptin, fixed-dose combination alogliptin and pioglitazone, Liovel, Emtricitabine and tenofovir disoproxil fumarate, Truvada, Gilead Sciences, Lorcaserin, Arena Pharmaceuticals, Eisai, Tofacitinib, Pfizer, Tafamidis, ACH-3102, Achillion, CK-2017357, Cytokinetics, Taliglucerase alfa, Elelyso, Pfizer, Carisbamate, SK Biopharmaceuticals, Vancomycin hydrochloride, Vancocin, Akorn, Watson
On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis).
As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.
A look at liposomal bupivacaine, a local anesthetic providing pain relief post-surgery
New molecular entity: FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.
Chronic kidney disease (CKD) remains a significant cause of morbidity and mortality. Here's a review of treatment options and guidelines to delay disease progression.
Market is expanding for government health IT contracts.
Managed care organizations need to look toward the future market in long-term care.
A survey by Express Scripts shows that patients tend to think that they are more compliant than they are.
Healthcare experts say a move away from the fee-for-service payment model can't happen too soon.
Support school nurses who can improve kids' health.
Providers, especially primary care physicians, are struggling to meet increasing demands.
Few consumers are able to find adequate cost and quality information that truly helps them make cost-conscious healthcare decisions
Sure, you need to eat right and exercise, but why aren't you doing it?
With health reform transforming the industry, a study from the Employee Benefit Research Institute (EBRI) shows the current realities of employer-based care.
Well-constructed data integration strategies can help manage the swelling data flood.
A policy requirement that employers with more than 200 full-time employees must enroll their employees in a company health plan may not take effect until 2015.