PCORI now has a chairman and board representing all stakeholders to take on the daunting task of setting the national CER agenda, developing systems for funding research, establishing standards and methods for comparative studies, and devising programs to disseminate results to practitioners and to the public.
Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex
Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.
Congress has enacted legislation mandating notice to individuals whose personal information has been compromised
When it comes to insurance, the latest figures from the U.S. Census Bureau show 2009 was a year of superlatives, and none of them good.
New worries should not distract executives from addressing rising costs and threats of consolidations
The federal government is out to change the nature of healthcare from reactive to proactive
HHS is providing some breathing room before employers and insurers have to meet new requirements
The most powerful person in the nation's healthcare system made a heartfelt call for industry assistance in reforming healthcare.
Employers are beginning to focus on price in the broader context of value according to industry analysts
New regulations challenge Medicare Advantage products, but HealthSpring is relying on the future outlook for larger plans in the MA market
The adoption of healthcare reform has created an environment that encourages insurers, health plans, hospitals and clinicians to seek common ground
California is making a statement as the first state to create an oversight board for insurance exchanges, in compliance with the requirements established by the Patient Protection and Affordable Care Act
Many of the estimated 5.1 million Americans with Alzheimer's disease also have other serious medical conditions
As healthcare stakeholders try to steer consumers to the most effective care delivery, they first need to overcome longstanding hurdles, including reliable quality measures
Consolidation is going to heat up in healthcare for two reasons
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.
