The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.
Angiotensin receptor blockers do not increase the risk of developing cancer in patients using the medications, FDA announced recently after a safety review.
Aidapak Services has issued a voluntary recall of a large number of repackaged drug products after learning of the potential cross contamination of non-penicillin with penicillin drug products repackaged in the same facility.
FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.
An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.
A 56-week phase 3 data for orphan drug lomitapide are consistent with 26-week data, showing that the drug significantly reduced low density lipoprotein cholesterol levels in patients with homozygous familial hypercholesterolemia, according to the drug?s manufacturer Aegerion Pharmaceuticals.
Lacosamide (Vimpat, UCB) appears both cost- and utility-effective as an add-on therapy for adults with uncontrolled partial-onset seizure, according to a pharmacoeconomics analysis that was recently presented at the International Society for Pharmacoeconomics Research.
Dietary calcium intake above 750 mg does not provide added benefit against risk of fractures or osteoporosis, according to the results of a large prospective longitudinal cohort study reported in the May 24 issue of the British Medical Journal.
Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.
FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.
An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.
Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health (Add Health) published online May 23 in Epidemiology.
FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.
An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.
Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine.
FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.
There is no clear difference in benefit between drug classes when adding an antihyperglycemic as a third agent to the treatment of patients with type 2 diabetes who are already receiving metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of Annals of Internal Medicine.
Comparative effectiveness research will take a more prominent role in payer policies and programs, as the Patient-Centered Outcomes Research Institute will increase CER and CER will be used by Medicare and managed care organizations in development of clinical policies and programs, according to a recent audio conference.
The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.
Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.
FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.
The pipeline continues to decline from 4 to 5 years ago where smaller molecules led the way, according to a current state of the pharmaceutical pipeline presentation at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis.
Chronic hepatitis C virus affects more than 170 million people worldwide and is the most common chronic blood-borne infection in the United States. Telaprevir is a member of a new class of specifically targeted antiviral therapies for HCV.
New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.
