FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.
OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.
Childhood obesity has tripled in the past 30 years, leading to many chronic lifelong conditions. Obese children, for example, are more likely to have risk factors for cardiovascular disease, are at greater risk for bone and joint problems, and are more likely to become overweight as adults.
The newly created Center for Medicare and Medicaid Innovation (CMI), which was created by the Patient Protection and Affordable Care Act (PPACA), has an acting director. Richard Gilfillan, MD, who has directed the Centers for Medicare and Medicaid Services' (CMS') performance-based policy staff since August, has been named acting director of CMI.
The effectiveness of Total Health, a benefits program for Group Health Cooperative employees, is the subject of a four-year study that the federal Agency for Health Research and Quality (AHRQ) recently funded. It's part of a trend to integrate care, insurance, and wellness programs and base them on research findings. The goal is to help people stay healthier and control health care costs.
The New England Healthcare Institute (NEHI) is calling for a national strategy to examine the role care teams can have on improving patient adherence to prescription medicines. Given the shortage of primary care physicians and escalating health care costs, care teams may be useful to better medication adherence, but more research is needed on how to best deploy them in a wide variety of practice settings, according to a NEHI report titled "Medication Adherence and Care Teams: A Call for Demonstration Projects."
Intense public scrutiny of drug safety issues is prompting FDA to take a closer look at its program for establishing Risk Evaluation and Mitigation Strategies. Healthcare providers, as well as pharmaceutical companies, believe that the program is being overused, raising costs, and interfering with patient treatment.
Agents in late-stage development for pulmonary disease.
A new case-control study nested within a large database of human immunodeficiency virus (HIV)-infected patients found abacavir initiation was associated with increased odds of having a myocardial infarction, while longer exposure to abacavir was not.
Platelet response to clopidogrel (Plavix) may be enhanced by concomitant use of agents that induce cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), according to research presented during the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia) was approved for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor.
Atrial fibrillation (AF) is the most common form of arrhythmia, affecting an estimated 2.2 million people in the United States. The goal of treatment is to reduce symptoms through rate or rhythm control and to prevent a cardioembolic event. Dronedarone (pronounced droe'' ne' da rone) is a noniodinated benzofuran derivative with characteristics of all 4 Vaughan-Williams antiarrhythmic classes. A search in clinicaltrials.gov for dronedarone phase 3 studies yielded 5 randomized controlled studies that investigated the efficacy and safety of the drug.
Recent FDA Approvals (through August/September 2010) related to Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz.
Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
Non-Hodgkin's lymphoma (NHL) has several subtypes, with subtle variations, which leads to reduced effectiveness of standardized therapies. The introduction of rituximab, which targets B-cells, has had a positive effect on the management of NHL, but much still needs to be accomplished.
Pain is a significant medical problem and choosing the appropriate treatment may be complex. Opioids are considered a gold standard in the treatment of pain and as pain management has become a more prominent strategy, opioid dependence has become more frequent. The misuse and abuse of opioids have also increased. Successful management of opioid dependence requires utilization of both pharmacologic and nonpharmacologic treatment.
New combination: Dutasteride and tamsulosin (Jalyn) was approved by FDA for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
The bigger obstacle to overcome will be the general lack of understanding of the healthcare system
Aging baby boomers will bring more people into Medicare, while reform will expand Medicaid
Republicans introduced a bill to abolish Medicare's Independent Payment Advisory Board (IPAB) before it even gets off the ground
For health reform to be a success, employers must continue to provide healthcare benefits
Beyond basic compliance with the regulations, the market fallout could be anything from a pin drop to a sonic boom
Navigating legal issues to create the best possible program sometimes requires a delicate balancing act by plan sponsors
The empowered patient is one change that stands above all others
Provider groups are on task to create accountable care organizations (ACOs), and many believe they will change the delivery of healthcare
Most existing benefit plans will lose their grandfathered status by 2019, according to observers
Many fear that the $5 billion allocated by the federal government for high-risk insurance pools won't last until 2014
Now is the time for collaboration of payers, billers and providers to lead the industry by reducing inefficiencies
A cumulative 23% cut is scheduled for this December. Another 6.5% cut in January 2011 and a 2.9% cut in January 2012 are scheduled.
The stimulus package provided more than $1 billion in federal support for comparative effectiveness research (CER), which has the potential to improve clinical decision making