The addition of everolimus, an mTOR inhibitor, to trastuzumab and vinorelbine in heavily pretreated advanced breast cancer patients led to a 22% reduction in the risk of disease progression in the first phase 3 study showing that inhibition of human epidermal growth factor receptor-2 positive (HER2+) receptor and mTOR provides significant benefit in HER2+ advanced breast cancer.
Octreotide LAR not only prolongs time to progression (TTP) but also appears to extend overall survival (OS) in a subgroup of patients with metastatic midgut neuroendocrine tumors (NETs) and a low hepatic load.
Incidence of human immunodeficiency virus (HIV) has decreased dramatically since its emergence in the early 1980s, but it remains a worldwide epidemic. There is a reduction in newly diagnosed patients, but prevalence is increasing due to a longer life expectancy, which is attributed in part to highly effective antiretroviral therapies. Newly approved and investigational antiretroviral therapies provide additional options for the healthcare team to prevent progression of disease as well as transmission of HIV. Early detection and prevention of HIV is still paramount with the use of in-home HIV testing as well as antiretrovirals for pre-exposure prophylaxis. While many advances in HIV diagnosis and treatment have been made, the importance of education and risk avoidance cannot be underestimated.
FDA actions in brief
Complete response, priority review and orphan drug designations.
Educating pediatricians in their offices, auditing their prescription patterns, and leveraging a shared electronic health record, encourages them to choose more appropriate antibiotics for children with common respiratory infections, according to a study published in the June 12 issue of the Journal of the American Medical Association.
Medicinal cannabis, despite its emerging popularity, presents unique issues to managed care and hospital decision makers. Exactly how does a quasi-legal substance, which has existed outside the sphere of mainstream medicine, become integrated into a traditional hospital and managed care setting?
FDA issued a warning July 3 that olmesartan medoxomil, an angiotensin II receptor blocker (ARB), may cause sprue-like enteropathy several months to years after initiation of treatment.
Opioid overdose deaths in women in the United States increased fivefold from 1999 to 2010. During the same time period, the risk of opioid pain reliever (OPR) deaths in men increased 3.6 times, according to the July 2 Morbidity and Mortality Weekly Report.
The Academy of Managed Care Pharmacy (AMCP) will be hosting a new conference, Nexus 2013, October 15-18 in San Antonio, Texas. Nexus 2013 will aim to simplify the complex healthcare system and find new and innovative solutions by bringing together people from both sides of the equation. The new conference will be replacing AMCP’s Education Conference.
There was both bad and good news from the National Community Pharmacists Association’s (NCPA) national medication adherence report card survey results released recently.
FDA has approved low-dose paroxetine capsules (Brisdelle, Noven Pharmaceuticals), 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, also referred to as hot flashes and night sweats.
In addition to boosting patient health outcomes, medication therapy management (MTM) is vital to a pharmacy’s bottom line, according to various speakers participating in the recent Pharmacy Quality Alliance’s webinar “Boosting MTM Program Compliance.”
FDA has approved Coagulation Factor IX (Recombinant) (Rixubis, Baxter International) for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B.
The first of 2 pivotal phase 3 trials with a new allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases, has met its primary end points, according to ALK and partner Merck.
FDA has expanded the use of telavancin (Vibativ, Theravance) to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
The Centers for Disease Control and Prevention (CDC) recommended preexposure prophylaxis (PrEP) to injection drug users who are at high risk of HIV infection, following the positive results of the Bangkok Tenovir Study, published online June 12 in the Lancet.
Adding more than a one-half serving of red meat daily for 4 years can increase the risk of type 2 diabetes mellitus over the subsequent 4-year period, according to a report published online June 17 for JAMA Internal Medicine.
FDA approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II (Abbott Molecular) can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 using a sample of an infected patient’s blood plasma or serum, which will aid healthcare professionals in determining the appropriate approach to treatment, resulting in better patient outcomes. Various HCV genotypes respond differently to available drug therapies.
FDA announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 , order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
FDA approved the expanded use of denosumab (Xgeva, Amgen) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
FDA is investigating 2 unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate), according to an FDA Drug Safety Communication.
The US Supreme Court today stated that pay-for-delay agreements between brand name drug companies and generic manufacturers are subject to antitrust scrutiny.
Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
FDA has issued a complete response letter (CRL) to for Aveo’s investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).
FDA has approved the supplemental biologics license application (sBLA) for licensure of its 4-strain influenza vaccine, Fluzone Quadrivalent vaccine (Sanofi Pasteur).
