FDA has issued a new draft guidance to facilitate the development and review of companion diagnostics ?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.
While the National Community Pharmacists Association (NCPA) is in favor of the Medicaid Access Rule proposed by the Centers for Medicare and Medicaid Services (CMS), it has several concerns about the proposal.
Duane Reade?s new flagship store on Wall Street in New York City features sushi chefs and a new connection to Walgreens? pharmacy network. The Duane Reade store signals a prototype for future Duane Reade stores. Duane Reade is owned by Walgreens and has more than 250 stores in the New York City region.
Ohio proponents of medical marijuana use are working to get the issue on the ballot for the November 2012 general election, hoping to see the drug finally approved for medical use in the state.
New studies confirm that lower levels of vitamin D are associated with a higher risk of diabetes and diabetic retinopathy. But the mechanisms by which vitamin D may affect progression, beta cell function, dysglycemia, and retinopathy are not clear.
Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes. The loss-leader strategy used by big-box, chain, independent, and online pharmacies has boosted the mean cost of branded diabetes medications by up to 113% since 2008.
David D. Pope, PharmD, CDE, editor-in-chief of CreativePharmacist.com, has developed and directs an innovative, web-based program titled HealthyHeartClub.com, which offers accountability, encouragement, and education to help patients adopt healthier lifestyles and decrease cardiovascular risk.
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.
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.
FDA 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.
In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life in patients with painful diabetic neuropathy, a broad literature review was conducted and new guidelines were published online May 17 in Neurology and were presented at the American Academy of Neurology Annual Meeting in Honolulu.
FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.
An FDA advisory panel recommended in late June that Avastin should no longer be used to treat breast cancer.
Passing the MTM Empowerment Act and expanding Medicare Part D coverage should be Congress?s focus this session, says the National Association of Chain Drug Stores.
From Drug Topics staff reports Generic manufacturer Qualitest recently recalled several lots of drugs, including hydrocodone bitartrate and acetaminophen tablets, because of a labeling mixup.
The National Association of Chain Drug Stores (NACDS) is urging FDA to streamline patient medication information.
The first Senate Community Pharmacy Caucus was established in late June. Senator Jerry Moran (R-KS) and Senator Jon Tester (D-MT) created the caucus, which is meant to serve as an advocate for community pharmacy issues and as a clearinghouse of information for senators, staff, and other interested parties.
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.
The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) last week issued a serious medication alert about colistimethate.
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) for breast cancer be withdrawn.
Diabetic kidney disease has become more prevalent in the United States over the last 2 decades due to the expansion of the diabetes population, concluded a study published in the June 22/29 issue of JAMA.
Crizotinib, an investigational drug, demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer (NSCLC) with an anaplastic lymphoma kinase (ALK) positive genetic alteration, according to the results of an early-phase study presented at the 2011 annual meeting of the American Society of Clinical Oncology.
FDA has issued a warning that smoking-cessation aid varenicline (Chantix, Pfizer) may be associated with a small, increased risk of certain adverse events in patients who have cardiovascular disease.
Compared with moderate-dose therapy, intensive-dose statin therapy appears to be associated with increased risk of new-onset diabetes, concluded a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.
Walgreens announced last week that it is ending its relationship with pharmacy benefits manager Express Scripts as of January 1, 2012.
