News

FDA has approved vemurafenib (Zelboraf, Genentech), the second melanoma drug this year to improve overall survival. Zelboraf is indicated for the treatment of patients with late-stage (metastatic) or unresectable melanoma, the most dangerous type of skin cancer.

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.

FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

How much do employers know regarding biologics and specialty pharmacy?

FDA has approved the first antivenom treatment specifically for a scorpion sting by the Centruroides scorpions in the United States. The new biologic treatment?called Anascorp?was designated an orphan drug and given priority review because adequate treatment did not exist in the United States, according to a consumer update and corresponding news release issued by the agency.

The American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ACT), and the European Respiratory Society (ERS) have issued updated recommendations to the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD). The new recommendations were published in Annals of Internal Medicine.

Young adults treated with a statin after a first ischemic stroke of undetermined cause were 77% less likely to suffer subsequent vascular events, according to a recent study published in Neurology.

Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to the FDA.

FDA is warning consumers in the United States not to use an emergency birth control medicine labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.

The Centers for Disease Control and Prevention warned this week that the antimalarial drug primaquine is not available until September, 2011.

?Implementation of Medicare Part D and Nondrug Medical Spending for Elderly Adults With Limited Prior Drug Coverage? report finds that Part D implementation reduces nondrug medical spending for Medicare beneficiaries with limited prior drug coverage.

Pennsylvania?s HealthAmerica has announced the HealthAmericaOne Rewards program, which pays members for successfully completing health-promoting wellness activities.

Kaiser Permanente and University of California, San Francisco (UCSF) scientists have genotyped the DNA and analyzed the length of chromosome tips in more than 100,000 members.

New guidelines announced by the U.S. Department of Health and Human Services (HHS) require new health insurance plans to cover women?s preventive services such as well-woman visits, breastfeeding support, domestic violence screening, and contraception without charging a co-payment, co-insurance or a deductible

The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), has announced the appointment of 4 new FMCP Trustees.

The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.

FDA issued a warning this week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the Safety Alert released August 3.

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office?s ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA.

FDA has issued a Complete Response Letter (CRL) for Intermezzo (zolpidem tartrate sublingual tablet, Transcept Pharmaceuticals).

Over the past 3 decades, pharmacists have become integrated members of multidisciplinary teams. To recognize the value of the role of pharmacists in improving patient outcomes and safety in cardiac care, the American Heart Association (AHA) will offer pharmacists a session focused specifically on them at this year?s AHA Scientific Sessions in Orlando, Fla.

PriCara and Ortho-McNeil, divisions of Ortho-McNeil-Janssen Pharmaceuticals, will operate under the name Janssen Pharmaceuticals, the family of companies announced this week. The change, effective immediately, is part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity and to increase collaboration, the statement said.

More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug?s manufacturer Novartis.

A new report from the Institute of Medicine (IOM) recommends that 8 preventive health services for women will be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act of 2010 (PPACA).

Improving glycemic control may help prevent heart failure, according to a recent study published in The Lancet. The study enrolled at 20,985 patients with type 1 diabetes to assess variables associated with cardiovascular disease, including age, sex, duration of diabetes, HbA1c, body mass index, systolic and diastolic blood pressure, LDL and HDL cholesterol, and smoking status.

FDA has approved a subcutaneous (SC)formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.

FDA has issued a 90-day extension of the action date for Pfizer?s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.

FDA has received reports of serious central nervous system reactions when methylene blue is given to patients taking serotonergic psychiatric medications.

On August 9, Independence Blue Cross and Blue Cross Blue Shield of Michigan announced their alignment

Reform calls for establishment of the Consumer Operated and Oriented Plan, which permits new nonprofit insurers to offer plans in individual and small group markets