News

FDA has granted priority review to crofelemer 125-mg tablets (Salix Pharmaceuticals) for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).

Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) tablets? label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.

FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

Hospitals and healthcare facilities should require all employees to get an annual flu shot, a group representing many of the nation?s largest employers emphasized again at a press conference Wednesday in Washington, DC.

FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) ? the first once-weekly treatment for type 2 diabetes.

Cardiovascular agents

Clinicians are urged to be cautious when selecting an antiepileptic drug (aeD) for patients with HIV/AIDS, according to new evidence-based guidelines developed by the American Academy of Neurology (AAN) and the International League Against Epilepsy (ILae).

In patients with severe, refractory, persistent systemic juvenile idiopathic arthritis (JIA), long-term treatment with tocilizumab induces significant, durable responses with acceptable toxicity, according to results from a multicenter phase 3 trial presented at the annual scientific meeting of the American College of Rheumatology, Chicago.

Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)

In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).

Last month, economists in the Department of Health and Human Services (HHS) reported a big slow-down in healthcare spending for 2010. Outlays rose only 3.9% to $2.6 trillion, largely because the recession and unemployment reduced healthcare coverage and prompted people to skip doctor visits. Spending on prescription drugs increased at a record low 1.2% to $259.1 billion, as utilization stagnated, more generics replaced old blockbusters, and fewer new drugs came on the market.

An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.

An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.

New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.

In patients with major depressive disorder (MDD) and general medical conditions, the use of antidepressants was safe and effective compared to patients without such conditions. Combination therapy was no different than monotherapy, regardless of the number of comorbidities present, according to the recent findings of a new randomized, single-blind, placebo-controlled trial published in The Annals of Family Medicine.

Vaccines are one of the greatest achievements of biomedical science and public health. Proper vaccination plays a critical role in the reduction of vaccine-preventable disease and related morbidity and mortality.

Respondents to a Formulary readers' poll would reserve the use of newly approved rivaroxaban (Xarelto, Janssen) for the management of chronic atrial fibrillation (AF) to those patients who have contraindications to warfarin, had unmanageable side effects to warfarin, or in whom warfarin was ineffective.

New indication: FDA approved Zolpidem tartrate sublingual tablets or the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep.

Orally inhaled dihydroergotamine (DHE) is a newly developed formulation of DHE for the treatment of acute migraine attack and is undergoing FDA review.

Hospital-acquired Clostridium difficile significantly prolongs the duration of a patient's stay in the hospital by at least 6 days, according to the findings of a study published online December 5, for the Canadian Medical Association Journal.

Methotrexate alone, with step up to other therapies only if a response is not achieved, is a reasonable starting strategy for treating "poor prognosis" rheumatoid arthritis (RA), said James O'Dell, MD, at the annual scientific meeting of the American College of Rheumatology, Chicago.

Romiplostim (Nplate, Amgen), a synthetic protein that binds to and stimulates the thrombopoietin receptor, induced a rapid platelet response in most adult patients with immune thrombocytopenia (ITP) who had low platelet counts or bleeding symptoms, regardless of splenectomy status.

Recent FDA action (through January 2012) related to dapagliflozin, progesterone vaginal gel 8%, ACH-1625 protease inhibitor, CPP-115 GABA aminotransferase inhibitor, AC607, NBI-98854 VMAT2 inhibitor, AIC246 inhibitor, CBP501, Porfimer sodium, inhaled nitric oxide, carbamazepine extended-release capsules, levetiracetam extended-release tablets

In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.

The healthcare overhaul has allowed 2.5 million young adults to gain insurance coverage under their parents' plans, a figure that is more than double previous estimates.

Savings of $4.5 billion over 10 years is the projection by the federal governement relative to a new rule to standardize electronic funds transfers.

When it comes to health insurance and the Patient Protection and Affordable Care Act, defintion "affordable" can be a complex and confounding task.

Supreme Court unlikely to allow live C-SPAN coverage of the five and half hour healthcare reform hearing, unfortunately.