Food and Drug Administration (FDA) committees this week voted to approve GlaxoSmithKline and Theravance’s Breo ELlipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for 12 to 17-year-olds.
Formulary Watch
Latest News
All News
Advertisement
The FDA warns consumers not to rely on the use of over-the-counter homeopathic therapies for the treatment of asthma. Without appropriate management, asthma could lead to a life-threatening asthma attack. Homeopathic remedies have not be evaluated by the FDA and may interfere with asthma management.
In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.
FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of Major Depressive Disorder (MDD) in adults.
Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) appears to reduce the risk of colorectal cancer in most individuals, but a few individuals with rare genetic variants do not share this benefit, according to a study published in the March 17 issue of JAMA.
To address the burden of COPD on hospital expenditures, on October 1, 2014, the Centers for Medicare & Medicaid Services included COPD in its Hospital Readmissions Reductions Program. This inclusion resulted in reduced Medicare reimbursement for hospitals that demonstrate excessive 30-day COPD patient readmission rates.
FDA approved its first treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
The United States Drug Enforcement Administration (DEA) on March 18 issued a nationwide alert about the dangers of fentanyl and fentanyl analogues/compounds.
Lemtrada (alemtuzumab) received FDA approval on November 14, 2014, under fast track designation, for the treatment of patients with relapsing forms of MS.Due to the safety profile, alemtuzumab should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for MS.
FDA has approved asenapine (Saphris, Actavis) for treatment of manic or mixed episodes of bipolar I disorder in pediatric patients, ages 10 to 17 years old.
Advertisement
Alirocumab (Praluent), a PCSK9 inhibitor, reduced low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy, according to a study published online in the New England Journal of Medicine.
There is widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease or dementia who live at home or in assisted living facilities, according to a new General Accountability Office (GAO) report.
In patients with type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 (DPP-4) inhibitor alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes, according to data published in The Lancet.
Double-lung transplantation in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) was associated with better graft survival and patient survival than single-lung transplantation, according to a JAMA study.
FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.
FDA's approval of the “generic" biologic prescription version of cancer medicine Neupogen opens the door to a movement that could save the US healthcare system tens of billions of dollars a year, according to Forbes.
Better post-hospital care is needed for sepsis patients to avoid readmissions that drive up costs and interfere with recovery, according to a study published in the March 10 issue of JAMA.
Taking commonly used medications with anticholinergic effects is associated with a significantly higher risk for developing pneumonia, according to a study published recently in the Journal of the American Geriatrics Society.
FDA approved dinutuximab (Unituxin, United Therapeutics) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.
FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations
FDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.
Paracetamol (acetaminophen) is still safer than nonsteroidal anti-inflammatory drugs (NSAIDs), but there is concern about its potential for some side effects not usually considered related to paracetamol, according to a study published in the Annals of Rheumatic Diseases.
Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.
Because the use of corticosteroids in patients with severe community-acquired pneumonia is controversial, researchers in Spain set out to determine the benefits versus the pitfalls of using the adjunctive therapy.
The anticoagulant medication Fondaparinux (Arixtra) was associated with reduced major bleeding events and improved survival, compared to low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI), according to a new study.
Advertisement
Advertisement
Trending on Managed Healthcare Executive
1
Study finds gaps in recommended cardiac amyloidosis testing
2
Zucker School of Medicine receives $1.8 million grant to train physician-scientists
3
ctDNA in the de-escalation of breast cancer therapy. A puzzle not solved.
4
A conversation about pesticides and the rise of early-onset lung cancer in non-smokers, with Jorge Nieva, M.D.
5