Currently, exenatide is the only FDA-approved GLP-1 receptor agonist and its use is limited by the need for twice-daily injections. A long-acting release formulation of exenatide is being evaluated in clinical trials to assess effects on glucose control and patient quality of life.
Postmenopausal osteoporosis is a worldwide health concern associated with significant complications including fracture, disability, and mortality. The economic burden of this disease is substantial and is expected to increase significantly as the population ages. It is becoming increasingly important to identify patients who will benefit from available and emerging therapies for the prevention and/or treatment of osteoporosis.
Agents in late-stage development for renal disease
Recent FDA action (through February 2010) related to Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126
In less than 1 full year at the helm of FDA, Margaret (Peggy) Hamburg has worked to reposition FDA as a public health agency able to ensure the safety and quality of the nation's food supply and medical products.
Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose
After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.
Therapeutic strategies involving early conventional disease-modifying antirheumatic drugs or early biologics are preferred in treating very early rheumatoid arthritis, but the additional costs of early biologics may not be justified for all patients, according to a recent study reported in the Annals of Internal Medicine.
New molecular entity: Vigabatrin (Sabril) was approved as an adjunctive treatment of refractory complex partial seizures in adults who have responded inadequately to several alternative treatments; and as monotherapy for pediatric patients with infantile spasms.
Generic drugs approved by FDA (through February 2010): Donepezil hydrochloride orally disintegrating tablets, Ibutilide fumarate injection, Risperidone orally disintegrating tablets in 0.5-mg, 2-mg, 3-mg, and 4-mg strengths
A dosage of losartan of 150 mg/day is superior to 50 mg/day for the treatment of patients with congestive heart failure (CHF).
Lenalidomide plus high-dose dexamethasone compared with lenalidomide plus low-dose dexamethasone did not result in superior time to progression, progression-free survival, or overall survival in patients with newly diagnosed myeloma, according to a recent trial.
Extended-release niacin proved better than ezetimibe in favorably changing carotid intima-media thickness, a measure of atherosclerosis, in high-risk patients who were already receiving a statin.
New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).
Middle-aged (35 to 54 years) women are gaining ground on their male counterparts in their prevalence of myocardial infarction (MI) and their cardiovascular risk factor scores, according to an examination of the National Health and Nutrition Examination Survey (NHANES) over time.
Kasier Permanente is concerned that its physicians will be cut out of FDA programs
Here's a case where the payers were willing to talk, but the hospitals weren't
Insurers are no longer shy about letting members comment on care experiences
Poor adherence is the most common cause of treatment failure. Months of treatment and observation produces improvement
Clinic openings slowed from 350% growth in 2007 to 30% in 2008
Several public health threats prompted a new but underfunded plan
More specialty drugs means more management of patient needs and more cooperation
Economic drivers likely the cause of slowdowns in healthcare spending, but the general cost curve remains unsustainable
Medication adherence is the common goal of many stakeholders. Pharma is willing to help.
Everyone assumes the waste is caused by payers-think again! Administration might cost a few bucks, but it provides downstream benefits.
A panel of experts offers insight into experiences and future promise for the patient-centered medical home model
Plan administrators must provide notice of new COBRA extension to all eligible individuals
More gender-specific research is needed to improve poorer outcomes for women
The stars may be aligning for healthcare initial public offerings (IPOs) in 2010.
While the U.S. House and Senate wrangle over the final healthcare bill, health plans aren't sitting idly by waiting for the future to arrive.
