News

The American Medical Association released its "Health Insurer Code of Conduct Principles," which defines 10 standards AMA believes will ensure consistent corporate practices.

Primary care providers are increasingly caring for and treating people living with HIV, according to a recent survey by HealthHIV.

Innovative payers are starting to look differently at how they build their pharmacy network, using a bottom-up approach to network design.

Some 70% of survey prescription drug users reported concerns about therapeutic substitutions without a physician's consent.

The regulations provide guidance to employers and sponsors regarding the definition of a grandfathered health plan, as well as the changes that may and may not be made.

The application of pharmacogenomics-the science of how genetic variations influence drug response-is new to the field of health benefit management, and its potential to improve care and reduce costs is significant.

The Money Follows the Person (MFP) demonstration, a federal initiative launched in 2005 and extended in 2010 as part of the Patient Protection and Affordable Care Act, provides funds to help states transition elderly people and people with disabilities from long-term care institutions to receive care in the community in the setting of their choice.

The future presents significant challenges and opportunities for Medicaid directors, who can leverage their purchasing power to influence improvements in health care quality, delivery and value.

Savings could reach more than $1 trillion over a period of 10 years if 25% of individuals participate in risk reduction and prevention programs.

Recently, FDA Commissioner Margaret Hamburg, MD, addressed a press conference of global representatives from advocacy, industry, academia, and government who convened in Washington, DC, to launch a benchmark international consortium to fight tuberculosis (TB).

Using massively parallel gene sequencing technology, researchers were able to identify specific genetic mutations that appear to be predictive of response to a drug commonly administered for metastatic colorectal cancer.

Five-year data from a seminal study in patients with type 2 diabetes who are at especially high risk of heart disease show that intensive glucose control does slow the progression of microvascular disease, but mortality is increased and there is no benefit on macrovascular complications.

New data are changing the way gestational diabetes is diagnosed and treated.

The new standards using glycated hemoglobin for the diagnosis of diabetes issued in January 2010 have not come without controversy.

Agents in late-stage development for the treatment of female and male cancers.

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).

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.