Agents in late-stage development for the treatment of female and male cancers.
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New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.
Forty-two cases of progressive multifocal leukoencephalopathy (PML) in patients receiving the humanized monoclonal antibody natalizumab have been documented since 2006 from MedWatch reports.
New Formulation: Aztreonam for inhalation (Cayston) was approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas Aeruginosa.
Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna
Generic drugs approved by FDA (through June 2010): Venlafaxine hydrochloride extended-release capsules, Meropenem for injection, Adapalene 0.1% gel, Aztreonam for injection, Oxaliplatin for injection
On June 11, 2010, FDA announced in a drug safety communication that the agency was currently evaluating whether the use of the angiotensin II receptor blocker olmesartan (Benicar, Daiichi Sankyo) (also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.
Transparency has become the lead philosophy governing biomedical research and regulation. FDA and the National Institutes of Health are requiring more disclosure of financial relationships between industry and scientists and physicians.
A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.
New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
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A recent landmark phase 3 trial in patients in remission from recurrent hepatic encephalopathy demonstrated that rifaximin at a dose of 550 mg twice daily is significantly more effective than placebo in maintaining remission and reducing the risk of hospitalization. Rifaximin's approval by FDA in March 2010, offers clinicians the first pharmacologic treatment for hepatic encephalopathy in more than 30 years.
In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.
A systematic review and meta-analysis evaluating the effects of rosiglitazone on cardiovascular morbidity and mortality confirmed the finding of increased odds of myocardial infarction with rosiglitazone.
Hemophilia is a rare congenital bleeding disorder, resulting from a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B). Deficiency of either of these factors interrupts normal hemostasis resulting in an inability to form a stable fibrin clot to halt bleeding. This article reviews the etiology of hemophilia, available pharmacologic approaches to bleeding episodes, and treatment options in the presence of complications.
A pilot study of resveratrol in 10 older adults suggests that the compound may be beneficial for patients with impaired glucose tolerance.
In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials.
A post hoc analysis of 5 clinical trials of liraglutide suggests that it was significantly better than active comparators on a composite end point of glycated hemoglobin less than 7% without hypoglycemia or weight gain, reported French investigators.
Liraglutide is more successful in reducing glycated hemoglobin levels to 7% or less regardless of baseline glycated hemoglobin level compared with sitagliptin in adults with type 2 diabetes, said Melanie Davies, MD, MB ChB, professor of diabetes medicine, University of Leicester, United Kingdom.
Patients who are not well controlled on metformin may get better control of glycated hemoglobin levels and weight using once-weekly exenatide than by titrating insulin glargine.
Data from phase 3 trials of an investigational once-weekly injectable human GLP-1 analog?taspoglutide?show that it compares favorably with currently available agents in terms of glycemic control while offering favorable gastrointestinal tolerability and equal or superior weight loss.
An experimental drug for hepatitis C from Vertex Pharmaceuticals, telaprevir, sharply increased the cure rate in a clinical trial, while reducing the time needed for treatment. Experts said the results could herald a new era in treating the sometimes-fatal disease that is often overlooked, as reported by The New York Times.
Most patients with resistant rheumatoid arthritis (RA) who failed to respond to an initial cycle of rituximab (Rituxan) showed clinical improvement following a second treatment cycle, a British study found, as reported by MedPage.
Most patients with resistant rheumatoid arthritis (RA) who failed to respond to an initial cycle of rituximab (Rituxan) showed clinical improvement following a second treatment cycle, a British study found, as reported by MedPage.
Researchers will explore whether a new, very low-cost, one-a-day combined ?polypill? could reduce the risk of heart attacks, strokes, and other cardiovascular problems across the world, in a major new international trial that has just launched, as reported by ScienceDaily.
In 2009, the drug trend for children, a measure of prescription spending growth, increased 10.8%, driven by a 5% increase in drug utilization and higher medication costs, according to the Medco 2010 Drug Trend Report.
Low-dose hormone therapy significantly reduced ?sleep time? awakenings caused by hot flashes in postmenopausal women, according to the results of a recent multicenter study conducted at 19 US sites.
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