For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.
In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.
After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.
A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).
Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.
Several blockbuster drugs will fight to hold onto their top spots in 2009 as new products come before FDA for marketing approval, reported Brian W. Kolling, PharmD, at a recent meeting of the Academy of Managed Care Pharmacy (AMCP) in Kansas City, Mo. Key therapies to watch as they move through the pipeline include medications for cardiovascular (CV) disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes.
Pharmacogenomics offer value measures to MCOs as specialty drug costs skyrocket.
As cancer emerges as world's top killer by 2010, MCOs will need to offer targeted education and outreach programs.
Critical information doesn't follow an elderly patient from one point of care to the next. CMS is looking at the issues via a pilot project will examine readmission rates of elderly patients to hospitals, especially within 30 days, from the same diagnosis.
As a compromise effort for individual insurance reform dies in Michigan, BCBSM is left with tough options.
New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.
Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide
Generic drugs approved by FDA (through January 2009) including rocuronium injection and budesonide inhalation suspension
Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.
Sugammadex is a novel, first-in-class, selective relaxant binding agent that encapsulates the nondepolarizing aminosteroid muscle relaxants rocuronium and vecuronium, reversing and preventing their neuromuscular block (NMB) action. Clinical trials have demonstrated that sugammadex is effective in reversing both rocuronium- and vecuronium-induced NMB, and the agent has been well tolerated in studies.
Agents in late-stage development for the treatment of depression and generalized anxiety disorder
Lack of interoperability opens Medicaid programs to fraud and waste, but registry hubs can be a solution to help streamline IT systems.
Cancer patient advocates are concerned that management strategies are reducing access to treatment options.
2009 sure to be a year of quick changes
Not only does the cost shift from public programs increase premiums and costs in the private market, private plans pay taxes to boot.
Healthcare leaders are concerned about future public programs under the new administration that simply shift costs
Most consumers and healthcare experts want to see a reduction in costs or coverage expansion in 2009
Commonwealth Fund Performance Ranking: 1
Your retiring employees are taking their knowledge and experience with them. Transition them out while ramping up a new work force.
The disabled, elderly and poor populations would benefit from Medicare / Medicaid integration, but barriers have yet to give way
CMS is sending a message that all prescribers must begin using electronic tools to increase safety and reduce costs. Commerical payers are onboard.
We're winning the war on chronic disease, but we've reached a tipping point in DM strategies
New political leaders and intense economic woes set the stage for a new day in healthcare reform. No one disagrees with the need, just the means for getting there.
Brokers can no longer churn enrollees from plan to plan just to gain extra commission checks
Some plans are responding to disruptive innovations with innovative delivery strategies
