Older men with metastatic castration-resistant prostate cancer (mCRPC) derive a similar if not superior survival benefit from treatment with enzalutamide as do younger men, according to a post-hoc analysis of the phase III AFFIRM trial.
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Autism spectrum disorders (ASD) are complex neurodevelopmental disorders that involve significant social functional impairment and behavioral inflexibility. Autism is the most severe form of ASD and includes significant impairment in communication skills. Treatment of ASD is complex and involves a comprehensive educational interventional plan. Medications are used only as adjuncts, and only in cases in which maladaptive behaviors are severe or life-threatening, or to enable a patient to participate in their behavioral therapies. The most commonly used medications include second-generation antipsychotics (SGAs), selective serotonin reuptake inhibitors (SSRIs), and psychostimulants. Risperidone and aripiprazole are the only medications to carry an FDA indication to treat ASD-related symptoms. There is interest in using newer agents, such as atomoxetine, galantamine, rivastigmine, and memantine, to treat ASD-associated symptoms, but data are lacking to support their use.
Use of tivozanib, an experimental tyrosine kinase inhibitor (TKI) with increased specificity and potency for the vascular endothelial growth factor (VEGF) receptor, as initial targeted therapy for patients with advanced renal cell carcinoma did not translate into improved overall survival compared with sorafenib (Nexavar) in a phase 3 clinical trial.
The standard of care for hepatitis C (HCV) was uprooted in 2011. Prevailing treatment involved a combination of 2 drugs-pegylated-interferon and anti-viral ribavirin-taken for 1 year. Two new protease inhibitors, boceprevir and telaprevir, joined the regimen.
In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.
Medication Reconciliation, “Med Rec” as it has come to be known, is recognized as an important part of the growing practice of medication management and a critical step in improving the care of patients in all settings. Despite the many challenges associated with implementation of a successful Med Rec program, the potential for significant value drives the ongoing effort to find scalable, cost-effective solutions.
Anticoagulation while on docetaxel (Taxotere) chemotherapy is an independent predictor of survival in men with metastatic castration-resistant prostate cancer (mCRPC).
Pipeline preview, FDA actions in brief
Ponatinib (Iclusig; Ariad Pharmaceuticals) is an oral tyrosine kinase inhibitor (TKI) that was approved by FDA on December 14, 2012, for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myelogenous leukemia (CML) that is resistant or intolerant to previous TKI therapy, and for Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (Ph+ALL).
A new multinational study confirms the impact of the recently-approved lung cancer medication, crizotinib, on testosterone. The study was published online first in the April 12, 2013, issue of Cancer.
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Prenatal exposure to valproate significantly increased the risk of autism spectrum disorder and childhood autism in the offspring of mothers who took the anti-epileptic agent, according to a study published in the April 24 issue of the Journal of the American Medical Association.
A draft bill that hopes to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.
FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.
FDA issued a warning April 26 that the anti-seizure drug, ezogabine (Potiga) may cause pigment changes in the retina as well as blue skin discoloration. It is not known if the changes are permanent, according to an FDA drug safety communication.
The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has halted a phase 2b clinical trial, HVTN 505, evaluating a sequential regimen of 2 HIV vaccine candidates.
Actavis will be able to sell defined quantities of a generic version or an authorized generic version of reformulated OxyContin as early as next year, according to a prepared statement from Purdue Pharma L.P., the manufacturer of the opioid analgesic
Patients who fail to fill a new prescription for statin therapy have a number of reasons, including negative perceptions about the medication, a preference for lifestyle modifications, concerns about side effects, drug interactions, polypharmacy, and a perception that they do not need the drug, according to a study published by The American Journal of Managed Care.
L-carnitine significantly improves cardiac health in patients after a heart attack, according to a multicenter team of investigators in a study published in Mayo Clinic Proceedings.
Global progress has been made since the introduction of pneumococcal conjugate vaccines (PCVs) 13 years ago, according to a report published in the April 26 Morbidity and Mortality Weekly Report (MMWR).
FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.
As FDA takes an increased interest in the prescribing of narcotic medications, due to higher levels of prescribing and increased overdoses over the recent years, the American Society of Health-System Pharmacists (ASHP) stressed the importance of understanding the causes of pain and issues of patient access to appropriate drug therapy.
FDA announced April 16 that it will not approve any generic versions of the original OxyContin formulation as the benefits no longer outweigh its risks. The original OxyContin was withdrawn from sale for reasons of safety, as it could be easily misused and abused by crushing and snorting. The original formulation was approved in 1995.
Healthcare providers believe that the pharmaceutical industry could play an important role in helping value-based healthcare providers such as accountable care organizations to deliver better care at lower cost. But pharma companies currently do a poor job of delivering the kind of data needed to accomplish that goal, according to a survey of physicians in value-based delivery models, conducted by Oliver Wyman, a New York-based management consulting firm.
Women at the highest risk for breast cancer benefit the most from preventive drug therapy, including tamoxifen and raloxifene, according to a study, published in the April 16, 2013, issue of the Annals of Internal Medicine.
The increase in utilization of generic drugs is driving costs down, while the increase in specialty pharmacy utilization is driving costs up, according to the 2013 CVS Caremark annual Insights Report.
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