FDA faces congressional probes and more transparency and organizational changes
February 1st 2011With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.
Read More
FDA: Dolasetron mesylate IV no longer indicated for CINV
February 1st 2011Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.
Read More
Study finds different opioids offer variable safety in older adults with noncancer pain
February 1st 2011Different opioids had different safety profiles when administered to older adults for noncancer pain, according to results from a new study published in the Archives of Internal Medicine.
Read More
Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
February 1st 2011New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.
Read More
Formulary design, individual mandate key to healthcare reform law
January 28th 2011With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers.
Read More
FDA sends complete response letter to MannKind regarding new inhaler
January 28th 2011FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
Read More
Medication adherence by elderly after MI is low
January 21st 2011Elderly patients have difficulty with long-term adherence to medications following myocardial infarction, and this is significantly worse among those with kidney dysfunction, according to a study published online January 13 in the Clinical Journal of the American Society of Nephrology, HealthDay News reported.
Read More
Risk of nontraumatic fractures may rise with use of antiepileptic drugs
January 21st 2011Antiepileptic drugs may increase the risk of nontraumatic fractures in patients aged 50 years and older, according to a study published in the January issue of the Archives of Neurology, HealthDay News reported.
Read More
Patients see greater BP drop with combination therapy at the start
January 21st 2011A combination drug therapy given initially appears to result in better blood pressure control in individuals compared with those who are treated with monotherapy, according to research published online January 13 in The Lancet, HealthDay News reported. Those who underwent the 2-drug treatment after taking the single-drug therapy also experienced better blood pressure outcomes, though not at the same level as those who began with the combination treatment.
Read More