News

The concentration of the influenza drug oseltamivir phosphate (Tamiflu, Genentech) for oral suspension has been reduced from 12 mg/mL to 6 mg/mL to reduce the possibility of prescribing and dosing confusion that can lead to medication errors, according to FDA.

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.

The Centers for Disease Control and Prevention (CDC) is concerned about the increasing potential in gonorrhea patients for resistance to cephalosporin.

Medications with anticholinergic activity increase the cumulative risk of cognitive impairment and death, according to findings from a study published online June 24 in the Journal of the American Geriatric Society.

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FDA has issued a new draft guidance to facilitate the development and review of companion diagnostics ?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.

Disease-modifying antirheumatic drugs (DMARDs) may lower diabetes (DM) risk in patients with rheumatoid arthritis (RA) or psoriasis, according to a study published in the June 22 issue of the Journal of the American Medical Association.

Exposure to fluoxetine and paroxetine in early pregnancy is associated with a small but established risk of specific cardiac anomalies, according to a study published in the July issue of Obstetrics and Gynecology.

Chronic self-reported use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with coronary artery disease (CAD) and hypertension is associated with harmful outcomes and alternative methods of pain relief should be considered, according to a study in the July issue of The American Journal of Medicine.

A new analysis released by the Kaiser Family Foundation?s Commission on Medicaid and the Uninsured provides an overview of online applications for Medicaid and/or Children's Health Insurance Program (CHIP).

Blue Cross Blue Shield of Michigan (BCBSM) has designated roughly 2,500 physicians in 770 practices across the state as patient-centered medical homes (PCMH), a 28% increase from the 1,800 designated PCMH physicians in 2010.

A new analysis released by the Kaiser Family Foundation?s Commission on Medicaid and the Uninsured provides an overview of online applications for Medicaid and/or Children's Health Insurance Program (CHIP).

Pennsylvania?s Independence Blue Cross (IBC) is changing the way it pays primary care physicians via its Integrated Provider Performance Incentive Plan (IPPIP).

Senate bill seeks to prohibit Medigap policies from covering the first $550 in healthcare costs as a way to make seniors more cost-conscious.

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults aged 65 years and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group.

DA has approved the first and only fentanyl nasal spray (Lazanda, Archimedes) in the United States for the management of breakthrough pain in cancer patients aged 18 years and older who are already receiving opioid therapy to which they are tolerant, for their underlying persistent cancer pain.

An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer.

Amgen has submitted a supplemental Biologics License Application to FDA to expand the indication for Xgeva to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release.

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies.

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis, which may lead to a pulmonary embolism in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

In the face of dozens of pink-clad demonstrators at the gates of FDA and many heartfelt pleas from women with metastatic breast cancer, an advisory committee to the agency voted unanimously at the end of June to hold firm in its recommendation that approval for Avastin (bevacizumab, Genentech/Roche) for breast cancer be withdrawn.

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life (QOL) in patients with painful diabetic neuropathy (PDN), a broad literature review was conducted and new guidelines were published online May 17 in Neurology, as well as presented at the American Academy of Neurology Annual Meeting in Honolulu.

FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

Intensive-dose statin therapy appears to be associated with an increased risk of new-onset diabetes compared with moderate-dose therapy, according to a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.