Recently, FDA Commissioner Margaret Hamburg, MD, addressed a press conference of global representatives from advocacy, industry, academia, and government who convened in Washington, DC, to launch a benchmark international consortium to fight tuberculosis (TB).
Using massively parallel gene sequencing technology, researchers were able to identify specific genetic mutations that appear to be predictive of response to a drug commonly administered for metastatic colorectal cancer.
Five-year data from a seminal study in patients with type 2 diabetes who are at especially high risk of heart disease show that intensive glucose control does slow the progression of microvascular disease, but mortality is increased and there is no benefit on macrovascular complications.
New data are changing the way gestational diabetes is diagnosed and treated.
The new standards using glycated hemoglobin for the diagnosis of diabetes issued in January 2010 have not come without controversy.
Agents in late-stage development for the treatment of female and male cancers.
New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.
Forty-two cases of progressive multifocal leukoencephalopathy (PML) in patients receiving the humanized monoclonal antibody natalizumab have been documented since 2006 from MedWatch reports.
New Formulation: Aztreonam for inhalation (Cayston) was approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas Aeruginosa.
Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna
Generic drugs approved by FDA (through June 2010): Venlafaxine hydrochloride extended-release capsules, Meropenem for injection, Adapalene 0.1% gel, Aztreonam for injection, Oxaliplatin for injection
On June 11, 2010, FDA announced in a drug safety communication that the agency was currently evaluating whether the use of the angiotensin II receptor blocker olmesartan (Benicar, Daiichi Sankyo) (also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.
Transparency has become the lead philosophy governing biomedical research and regulation. FDA and the National Institutes of Health are requiring more disclosure of financial relationships between industry and scientists and physicians.
A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.
New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
A recent landmark phase 3 trial in patients in remission from recurrent hepatic encephalopathy demonstrated that rifaximin at a dose of 550 mg twice daily is significantly more effective than placebo in maintaining remission and reducing the risk of hospitalization. Rifaximin's approval by FDA in March 2010, offers clinicians the first pharmacologic treatment for hepatic encephalopathy in more than 30 years.
In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.
A systematic review and meta-analysis evaluating the effects of rosiglitazone on cardiovascular morbidity and mortality confirmed the finding of increased odds of myocardial infarction with rosiglitazone.
Hemophilia is a rare congenital bleeding disorder, resulting from a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B). Deficiency of either of these factors interrupts normal hemostasis resulting in an inability to form a stable fibrin clot to halt bleeding. This article reviews the etiology of hemophilia, available pharmacologic approaches to bleeding episodes, and treatment options in the presence of complications.
One approach to aligning cost/quality outcomes is Value-Based Benefit Design which is designed to lower out-of-pocket costs for high-value services while providing greater quality of life for members
According to several presenters at the recent America's Health Insurance Plans Institute, coordination, communication and challenges are now the industry's driving forces.
Federal officials are pressuring insurers to keep premium rates under control for the coming year.
Most allergies are due to a combination of genetic factors and environmental exposure. The first step in coping with allergies is to reduce exposure to triggers.
In this environment, payers must provide added benefits while holding the line on costs.
Clinician handwashing protocol varies widely. Standardized measures for monitoring handwashing are lacking and tracking costly hospital-acquired infections in relation to hand hygiene is spotty at best.
Patients who do not follow their medication regimens cost the U.S. healthcare system an estimated $290 billion a year, or 13% of total healthcare expenditures.
The Commonwealth Fund supports research on practical healthcare issues to drive improvement, while also sharing data publicly. Lately, its task has been formidable.
Approximately 75 million Americans have two or more chronic conditions, Often the sickest members of a population, they experience a serious disconnect.
The restaurant industry is the second largest private-sector employer which also represents a significant portion of the uninsured population.
A far-reaching provision related to the Patient Protection and Affordable Care Act involves the 1099 tax reporting requirements and how they are expanded in the healthcare reform.
