The 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.
Label 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.
Injections 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.
A 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.
House and Senate leaders announced final agreement June 18 on legislation that authorizes industry user fees to support FDA regulatory programs.
Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.
FDA has approved the first combination vaccination for use in children aged 6 weeks through 18 months for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenza type b, according to an FDA statement.
As the Supreme Court debates the constitutionality of the Patient Protection and Affordable Care Act, some states are taking a wait-and-see attitude on health insurance exchange implementation, while others are forging ahead. Meanwhile, private exchanges are gaining some traction.
Approximately half of drug labels don’t have information on the medication’s safety and proper dosing in children, revealing an overall lack of study of children’s drug therapies, according to a study from FDA researchers.
A substantial proportion of patients initiating an oral hypoglycemic drug do not receive the recommended therapy. The potential savings from improved adherence to the recommendations could top $420 million annually.
People with private individual health insurance will save between $280 to $589 annually via health exchanges under the Patient Protection and Affordable Care Act. But who will pay for those savings?
Daily vitamin D (≤400 IU) and calcium (1,000 mg) supplements for the primary prevention of fractures in postmenopausal women are no longer recommended as they don’t help prevent fractures and may cause harm, according to draft guidance from the US Preventive Services Task Force.
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.
