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Formulary E-News
August 19, 2010
TOP SEARCHES: Hemophilia // Gene testing // Rifaximin
In this issue
New standard in leukemia
Pancreatic tumors
First-time generic Lovenox
Diabetes and hypertension
Pediatric trials
MPV4 vaccine
Lorcaserin
Weight loss combo
Oral antidiabetic agents
AEDs linked to suicide
Hospital-acquired MRSA
Longer Valcyte therapy for CMV
NovoSeven RT
Key Topic Updates

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Meeting Coverage

New tyrosine kinase inhibitors may represent new standard in chronic-phase CML
Major molecular responses are more common with the next generation of tyrosine kinase inhibitors as first-line options compared with imatinib for the treatment of newly diagnosed patients with chronic myelogenous leukemia (CML). Two separate studies confirmed superior response rates with dasatinib and nilotonib versus the current first-line standard imatinib. More...

Continuous daily sunitinib enhances response rates in advanced pancreatic tumors
Continuous daily sunitinib significantly improves overall survival and progression-free survival in patients with advanced pancreatic neuroendocrine tumors, according to data from a phase 3 study. More...

Triple antihypertensive combination therapy may be better than dual therapy in diabetic patients with hypertension
Investigational triple antihypertensive combination therapy lowers blood pressure more effectively than dual therapy in diabetic patients with hypertension, according to the results of a subgroup analysis of the TRINITY study. More...

Bias risk higher in industry-funded pediatric studies
A high proportion of pediatric, randomized controlled trials have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatrics, HealthDay News reported. More...
MPV4 vaccine not linked to Henoch-Schönlein purpura
Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura in 16- to 20-year-olds, according to research published online July 12 in Pediatrics, HealthDay News reported. More...
Lorcaserin linked to weight loss, maintenance
The use of lorcaserin, along with behavioral modification, is associated with weight loss and subsequent weight maintenance compared with placebo, according to a study published in the July 15 issue of the New England Journal of Medicine, HealthDay News reported. More...
Naltrexone, bupropion combination helps individuals lose excess weight
Investigational combination treatment with sustained-release (SR) naltrexone and bupropion (Contrave, Orexigen Therapeutics)—plus lifestyle modification, appears effective in helping people lose 5% or more of their excess body weight, according to research published online July 30 in The Lancet, as reported by HealthDay News. More...
OAD agents effective in reducing hemoglobin levels up to 1.5%
Oral antidiabetic (OAD) agents generally result in a maximum 1.5% drop in hemoglobin (Hb)A1C levels, with sulfonylureas and thiazolidinediones having a slightly more beneficial effect than other classes of oral agents, according to research published in the August issue of Diabetes Care, as reported by HealthDay News. More...
Newer AEDs linked to self-harm, suicidal behavior
Patients taking newer antiepileptic drugs (AEDs) that are associated with a high risk of depression may have an elevated risk of self-harm or suicidal behavior, but other groups of AEDs do not appear to carry the same risk, according to research published in the July 27 issue of Neurology, as reported in HealthDay News. More...
Hospital-acquired MRSA infections decline between 2005 and 2008
Infections with the deadly methicillin-resistant Staphylococcus aureus (MRSA) bacteria that begin in hospitals and other healthcare settings have declined 28% over a 4-year period, according to a new Centers for Disease Control and Prevention study of about 15 million people. The study was published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News. More...
FDA approves first-time generic Lovenox
No sooner does Sandoz begin shipments of the generic version, Sanofi-Aventis, manufacturer of Lovenox, files a lawsuit to prevent the approval of the generic. More...
FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients
FDA approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease, according to Genentech Inc. on Aug. 10. More...
Novo Nordisk gets approval for 8-mg vial of NovoSeven RT
FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8-mg vial size, making the hemophilia A or B with inhibitors treatment available in 1-, 2-, 5-, and 8-mg vials, Novo Nordisk announced on Aug. 10. The 8-mg vial allows a rapid initiation and administration of the medication for those patients who need a larger dose. More...
Key Topic Updates
FDA Approvals
Aztreonam for inhalation (Cayston): An inhaled antibiotic to improve lung symptoms in cystic fibrosis patients with pseudomonal infections
Denosumab (Prolia): A human IgG2 monoclonal antibody that binds to RANKL (or receptor activator of nuclear factor kappa-B ligand), preventing RANKL from activating its receptor (RANK) on the surface of osteoclasts
FDA Actions in Brief July 2010 (Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna)
First-time generic approvals July 2010

In the Pipeline
FDA Pipeline Preview, July 2010 (Aspirin/esomeprazole, Meningococcal and Hib combination vaccine, Eslicarbazepine acetate, Tesamorelin, Ulipristal acetate, flibanserin, Alemtuzumab, COL-172, Ex vivo expanded cord blood, Naltrexone for extended-release injectable suspension, Eribulin mesylate)

Medication Safety
FDA alerts to ongoing olmesartan cardiovascular review
Increased cataracts risk in elderly associated with SSRIs, SNRIs

Pharmacoeconomics
Gene testing stakes a claim in the health benefits marketplace

Drug Watch
Drug Watch: Agents in late-stage development for the treatment of female and male cancers (PDF) (July 2010)

Policy News
FDA commissioner announces launch of critical path to TB drug regimens

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