News

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.

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

Pharmacy professionals

Although Judy Cahill will end her term as CEO of the Academy of Managed Care Pharmacy next year, there's plenty to keep her busy between now and then.

When it comes to big health plan payers, hospitals aren't feeling the love. That's the feedback from Revive Public Relations' fifth annual national payer survey.

About 1 in 10 computer-generated prescriptions includes at least 1 error, and one-third of those has potential for harm, which is consistent with the error rate for paper-written prescriptions, according to a new study published online June 29 in the Journal of the American Medical Infomatics Association.

A smoking cessation program in which participants received mobile phone motivational text messages significantly improved smoking cessation rates at 6 months and the method should be considered for inclusion in smoking cessation services, according to a study published June 29 in The Lancet.

The US Centers for Disease Control and Prevention (CDC) has released revised recommendations for postpartum contraceptive use based on an assessment of new evidence, according to an article published in the July 8 issue of Morbidity and Mortality Weekly Report.

Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), and therefore is indicated for use only in transplant patients who are EBV seropositive.

Nesiritide cannot be recommended in the broad population of patients with acute decompensated heart failure, according to the results of a recent study published in the New England Journal of Medicine.

Novartis announced that it has stopped early its phase 3 trial of everolimus (Afinitor) plus exemestane in women with estrogen receptor-positive locally-advanced or metastatic breast cancer after an interim analysis showed that the primary end point of progression-free survival was met, the company said.

A recent study raises safety concerns associated with the use of varenicline among tobacco users. Use of the drug was associated with a 72% increased risk of serious adverse cardiovascular events and deserves further investigation, according to results of the study, which was published July 4 in the Canadian Medical Association Journal.

FDA has issued a new draft guidance to facilitate the development and review of companion diagnostics ? tests used to help healthcare professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency's policy for reviewing a companion diagnostic and the corresponding therapy.

Dronedarone (Multaq, Sanofi), which is approved for nonpermanent atrial fibrillation (AF), was being tested on patients with permanent AF. However, that trial, PALLAS (Permanent Atrial fibrillation outcome Study using Dronedarone on top of standard therapy) phase 3b, has been terminated because it was causing increased cardiovascular events.