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All News - Page 156
CDER to transition Office of Compliance to Super Office
June 17, 2011
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.
BUD/FORM maintenance and reliever therapy effective asthma control
June 17, 2011
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 risk of cancer, FDA finds
June 17, 2011
Angiotensin receptor blockers do not increase the risk of developing cancer in patients using the medications, FDA announced recently after a safety review.
Drug products recalled for possible penicillin cross-contamination
June 17, 2011
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 reviews safety of drospirenone for increased DVT, PE risk
June 17, 2011
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.
For severe gouty arthritis, ACZ885 provides better pain relief and reduces risk of new attacks
June 10, 2011
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.
Lomitapide still looks promising at 56 weeks
June 10, 2011
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 demonstrates potential cost savings as add-on seizure therapy
June 10, 2011
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.
Higher calcium intake may not lower risk of fracture or osteoporosis
June 10, 2011
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.
IACs linked to increased risk of acute urinary retention in men with COPD
June 10, 2011
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.
REMS now available for Avandia; access to drug restricted
June 3, 2011
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.
Trilipix to stay on market, but FDA panel recommends new study
June 3, 2011
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.
Study finds unexpectedly high risk of hypertension for young adults
June 3, 2011
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 approves Solesta for fecal incontinence in adult patients
June 3, 2011
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.
Fixed-dose combination ARB plus CLD significantly lowers blood pressure
June 3, 2011
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.
Abiraterone acetate may improve survival for patients with metastatic advanced prostate cancer
June 3, 2011
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 approves Dificid for treatment of Clostridium difficile-associated diarrhea
June 3, 2011
FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.
Antihyperglycemic agents useful as third agent, but class preference unclear
June 3, 2011
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.
Formulary Digital Edition June 2011
June 1, 2011
Multiple sclerosis: A paradigm change with oral agents?; Focus On Telaprevir: A novel, protease inhibitor for the treatment of hepatitis C virus
Expect comparative effectiveness research to play a more notable role in payer policies, programs
June 1, 2011
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.
Policy-makers move to curb drug abuse, diversion and disruptions to ensure quality supply
June 1, 2011
The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.
Ranibizumab and bevacizumab show equivalent effects on visual acuity in patients with neovascular AMD
June 1, 2011
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.
Topiramate reclassified as Category D due to potential link to oral clefts in newborns
June 1, 2011
FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.
Academy of Managed Care Pharmacy: Cancer, diabetes, cardiovascular agents fill pipeline
June 1, 2011
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.
Telaprevir: A novel, protease inhibitor for the treatment of hepatitis C virus
June 1, 2011
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.
Gabapentin enacarbil extended-release tablets (Horizant): Treatment for moderate-to-severe restless legs syndrome
June 1, 2011
New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.
Multiple sclerosis: A paradigm change with oral agents?
June 1, 2011
Multiple sclerosis is the most common disabling neurologic disease afflicting young adults in the United States. Since the majority of MS patients have normal or near-normal life expectancy, the clinical and economic burden is substantial, with disability typically worsening over time. Disease-modifying therapies have been shown to decrease and postpone long-term disability by lowering the relapse rate, extending the remission phase, and reducing the accumulation of new magnetic resonance imaging lesions and related neurologic deficits.
Academy of Managed Care Pharmacy: Specialty drug approvals trend upward; biobetters gain momentum
June 1, 2011
Within the next 5 years, approximately $100 billion will be lost on previous blockbuster brands that will lose patent protection.
FDA Pipeline Preview, June 2011 (BioMimetic Therapeutics, Pfizer, D-Pharm, Bayer HealthCare Pharmaceuticals, Mithridion, Cytonet)
June 1, 2011
Recent FDA action (through May 2011) related to Augment Bone Graft, crizotinib, DP-b99 development program, regorafenib, MCD-386CR, liver cell infusion of donated human liver cells
Belimumab intravenous injection (Benlysta): IV injection for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus already receiving standard therapy
June 1, 2011
New biologic: Belimumab intravenous injection is a B-lymphocyte stimulator-specific inhibitor approved by FDA to treat systemic lupus erythematosus.
