News

Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The US Department of Justice (DOJ) and Medco Health Solutions, a large pharmacy benefit manager (PBM) based in Franklin Lakes, NJ, reached a settlement over allegations that the PBM had submitted false claims to the federal government, had paid kickbacks to health plans to obtain business, and had both solicited and accepted kickbacks from pharmaceutical companies.

The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..

Methicillin-resistant Staphylococcus aureus (MRSA) strains showing reduced susceptibility to vancomycin (minimum inhibitory concentration [MIC] of 2 mcg/mL) and requiring aggressive empiric vancomycin dosing are highly prevalent among those that cause invasive infections, according to a prospective cohort study.

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.

Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).

Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations

Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Review of agents in late-stage development for the treatment of ankylosing spondylitis, osteoarthritis, and related pain (December 2006).

When you're in the innovation business, you take some risks and temper your expectations. When one of your innovations produces $100 million in annual savings, you know you're doing something right.

We've come a long way, baby. Yes, women in the workplace, in the board room, in political office-and in healthcare-have come a long way. A status report on Health Plan Employer Data and Information Set (HEDIS) measures specifically targeting women is showing upward trends, or at least steady statistics. Private health plans showed improvement in 35 out of 42 effectiveness of care HEDIS measures in 2005.

With business moving faster than ever, fragmented communications are typical. This leaves managers to wonder how to keep everyone in sync and correctly informed. Change management can play a key role toward ensuring success in major change events; however, it's critical to define what change management is. As defined by Prosci, a premier change management research organization, change management is the process of proactively managing the people side of change.

Price is paramount to survival in the current healthcare market. With skyrocketing premiums, moving toward an affordable level for both the employer and the employee/member is essential, experts agree.

The rise in popularity of consumer-driven healthcare (CDHC) will challenge HMOs to be at the top of their game, say industry watchers.

When you're in the innovation business, you take some risks and temper your expectations. When one of your innovations produces $100 million in annual savings, you know you're doing something right.

Health insurance is one of the most regulated industries in the world. Within its comprehensive regulatory scheme, there are several laws that are designed to assure the solvency of health insurance companies and HMOs. These laws limit and restrict the types of investments that these companies may own, dictate the level of capitalization they must maintain, and establish other solvency measures.

Like the wide-eyed toddlers who will stare in awe at their stack of holiday gifts this year, healthcare consumers certainly have a few surprises to get excited about as 2006 comes to a close.

When employees can't work because of sickness or injury, both employers and employees suffer. By using a holistic approach to maintaining a healthy workforce, employees are more secure, productivity improves and the cost of running a business can dramatically decrease.

Wherever you go, you can see technology's impact on our society. Household bills are paid online, satellites can locate your home from space, and cell phones have the ability to send and receive e-mail. Another area of society seeing a surge in technological advancement is the healthcare sector. From applying transactional data management for disaster recovery to implementing real-time analysis software to improving systems management, hospitals are adopting technology to ensure that their most important information-patient data is accessible and secure.

Low levels of testosterone are associated with an increased risk of mortality from coronary heart disease (CHD) in postmenopausal women, reported Gail A. Laughlin, PhD.

Men who suffer from migraines are at increased risk for cardiovascular events, according to researchers. The new findings follow similar reports that women with migraines are at higher risk for cardiovascular disease.

A change in resting heart rate in healthy middle-aged men is tied to mortality risk, with those who experience a long-term rise in resting heart rate having an increased risk of mortality and those with a long-term decrease in resting heart rate having a reduced risk of mortality.

After years of minimal results, stem cell research is forging ahead. "This is a new appetizer for what may be an excellent meal in years to come," said former AHA president Valentin Fuster, MD, PhD, at a press briefing Tuesday morning. "Reports the past couple of years have been equivocal at best."

A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).

The practice of late reperfusion-percutaneous coronary intervention (PCI) performed 2 to 28 days after myocardial infarction (MI)-in patients who are stable does not lead to improved clinical outcomes compared with medical therapy, said Judith S. Hochman, MD, lead investigator of the Occluded Artery Trial (OAT).