FDA expanded the approved use of ibrutinib (Imbruvica, Pharmacyclics and Janssen Biotech) as a single-agent, oral kinase inhibitor for chronic lymphocytic leukemia (CLL) patients who have received at least 1 previous therapy.
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The National Institutes of Health (NIH), FDA, 10 biopharmaceutical companies, the Pharmaceutical Research and Manufacturers of America, and several nonprofit organizations have launched an unprecedented public/private partnership to “transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease,” announced a recent statement from the NIH.
Riociguat (Adempas, Bayer Healthcare Pharmaceuticals Inc.) was approved by FDA on October 8, 2013 for two patient groups. It is intended for patients with pulmonary arterial hypertension (PAH) World Health Organization (WHO) group 1 to improve exercise capacity, improve WHO functional class, and delay clinical worsening. It is also approved for patients with pulmonary hypertension (PH) WHO Group IV who have inoperable or persistent/recurrent postoperative chronic thromboembolic pulmonary hypertension (CTEPH), with the intent of improving exercise capacity and WHO functional class.
After examining the latest research on nonsteroidal anti-inflammatory drugs (NSAIDs)-specifically whether naproxen carries lower cardiovascular (CV) risks than ibuprofen-an FDA panel has voted down the CV safety claim for naproxen.
For the first time, guidelines have been developed for preventing stroke in women.
Engaging pharmacists in healthcare information technology is crucial to increasing overall medication adherence in healthcare, panelists on the “Connected Health, Better Adherence” roundtable at the Pew Conference Center in Washington, DC, told attendees last week.
FDA actions in brief, complete response, breakthrough therapy designation, fast-track designation
An interdisciplinary group of pharmacists, pharmacy school and medical school faculty, pharmacy students, nurses, physicians, attorneys, and health advocates have called on Walgreens and Rite Aid to join CVS Caremark and stop the sale of tobacco products in their stores.
CVS Caremark is recognizing that cigarettes and pharmacies don't mix and will stop selling cigarettes and other tobacco products at its more than 7,600 CVS/pharmacy stores across the United States by October 1, 2014. This move makes CVS/pharmacy the first national pharmacy chain to take this step in support of the health and well-being of its patients and customers.
FDA said it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.
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Complex diseases present complex challenges for researchers, clinicians, drug manufacturers, and FDA for a variety of reasons. The impact, however, is felt at the patient level, particularly when there are no FDA-approved treatments. In some cases, such as myalgic encephalomyelitis, commonly known as chronic fatigue syndrome (ME/CFS), the devastating effects of the disease are exacerbated by the huge deficit in the drug application and approval pipeline. This leaves the patient population with little hope.
Researchers recently determined that acute otitis media is associated with an incremental increase in outpatient health care costs of $314 per child per year in the United States, which translates into approximately $2.88 billion in added health care expense annually.
FDA recently approved a unique test that can diagnose developmental delays and intellectual disabilities in babies postnatally.
Anti-muscarinic drugs are an option in the treatment of overactive bladder which is defined as urinary urgency with or without urge incontinence, usually accompanied by frequency and nocturia, in the absence of a urinary tract infection or other obvious pathology.Oral oxybutynin has been available by prescription for over 40 years, initially marketed as Ditropan® and Ditropan XL® although now generically availably, in addition to the transdermal patch Oxytrol and transdermal gel Gelnique. As an antagonist at muscarinic receptors, oxybutynin leads to relaxation of the smooth muscle of the bladder which leads to increased bladder capacity, decreased involuntary contractions and decreased urgency and frequency of both voluntary and incontinent episodes. The suggested dose is one patch applied for 4 consecutive days, after which the patch should be removed and a new one applied.
Adding evolocumab (Amgen) to statin therapy may help patients control their low-density lipoprotein cholesterol (LDL-C) levels when high doses of statins are not sufficient, according to results from a recent phase 3 study.
"Nudging" doctors with signed commitment letter in exam rooms lowered inappropriate antibiotic prescriptions for cold symptoms by nearly 20%, according to a study in JAMA Internal Medicine.
Two oncologists are calling on fellow oncologists and the American Society of Clinical Oncology (ASCO) to support a single-payer healthcare system, according to an article published in the January issue of the Journal of Oncology Practice.
For patients in the early stages of multiple sclerosis (MS), low levels of vitamin D were found to strongly predict disease severity and hasten its progression, according to a study online January 20, 2014 in JAMA Neurology.
FDA approved a 40 mg/mL dose of glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) to be used three times a week for patients with relapsing forms of multiple sclerosis (MS). This new higher-dose formulation will allow for a less-frequent dosing regimen.
A quality improvement initiative, conducted in a primary care setting, dramatically improved asthma control and outcomes for high-risk adolescents, according to a study published online in Pediatrics.
Ranbaxy Laboratories is being prohibited by FDA from manufacturing and distributing active pharmaceutical ingredients (APIs) from its Toansa, India, facility in order “to prevent substandard quality products from reaching U.S. consumers,” according to a news release.
More than 3 million Americans under aged 26 years have health insurance through their parents’ health plans. More than 9 million Americans have signed up for private health insurance or Medicaid coverage. And no American can be dropped or denied health insurance because of a pre-existing condition, said President Barack Obama about the Patient Protection and Affordable Care Act (PPACA) during his fifth State of the Union address on January 28th.
Working-age adults-aged 18 to 64-with diabetes appear to have an increased risk of being hospitalized for influenza compared to similar-aged adults without diabetes, according to a study in Diabetologia.
High concentrations of serum long-chain omega-3 fatty acids may help reduce the risk of type 2 diabetes, according to a University of Eastern Finland study published recently in Diabetes Care. The sources of these fatty acids are fish and fish oils.
While same-day tonsillectomy may be one of the most common and cumulatively costly surgeries for children in the United States, there is substantial variability in the quality of care and outcomes, reports a study in Pediatrics.
A recent study confirms cost recovery and long-term savings for morbidly obese patients undergoing bariatric surgery procedures. - See more at: http://formularyjournal.modernmedicine.com/formulary-journal/news/bariatric-surgery-demonstrates-cost-recovery-less-2-years-study#sthash.gdmwiTok.dpuf
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