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

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

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).

Pharmacist-directed education combined with prepackaging of medications increases compliance with medication schedules, leading to improvements in blood pressure and cholesterol levels among elderly patients, according to a study headed by Allen J. Taylor, MD.

The thiazolidinedione pioglitazone has a beneficial effect on carotid intima media thickness (CIMT) compared with glimepiride in patients with type 2 diabetes, said Theodore Mazzone, MD, lead investigator of the CHICAGO (Carotid Intima Media Thickness in Atherosclerosis Using Pioglitazone) study.

The first-ever anticoagulant drug-plus-antidote system has passed initial safety trials at Duke University in Durham, N.C. The new platform combines a short nucleic acid chain that quickly blocks clotting with an antidote that removes the clotting blockage in minutes.

Researchers in Japan have created the first heart valves using the recipients' own tissues-in rabbits. Growing replacement valves in a host with host tissue could virtually eliminate rejection when the valve is implanted.

A series of analyses offers no consensus on the safety of drug-eluting stents (DES) compared with bare metal stents. Depending on the study, DES either result in an increase in major adverse coronary events (MACE) or a decrease in subsequent need for coronary artery bypass graft (CABG) surgery and repeat percutaneous coronary intervention without an excess of adverse clinical events.

A comparison of the investigational COX-2 inhibitor etoricoxib and diclofenac found no increase in the risk of cardiovascular events over 3 years with etoricoxib.

Screening for coronary calcium may provide an impetus for physicians to initiate preventive cardiovascular therapies in patients who have coronary calcium, but persistence with the medications is no better than in patients who are started on therapies without a coronary calcium test, said Allen J. Taylor, MD

Implanting a pacemaker or a cardiac defibrillator is the beginning of treatment, not the end. That was the message from a panel of researchers who spoke yesterday at the AHA Scientific Sessions.

Healthcare is a disaster in progress. That was the stark warning from AHA president Raymond Gibbons, MD, during his presidential address yesterday at the American Heart Association (AHA) Scientific Sessions.