FDA approved Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults aged 18 years through 65 years.
FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.
As specialty drugs become the standard of care for many complex diseases, they present unique challenges to payers, according to the 10th edition of the EMD Serono Specialty Digest. Specialty drugs can be delivered through various routes of administration (subcutaneous injection, intravenous, intramuscular injection, oral), all of which may have unique coverage criteria, patient cost share, clinical management, and patient access.
Antipsychotic drugs are increasingly being prescribed to treat attention-deficit/hyperactivity disorder (ADHD) in children and teens in foster care, according to a study published in the Journal of Child and Adolescent Psychopharmacology.
FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.
The global insulin delivery devices market value is projected to increase from $8.78 billion in 2012 to $13.8 billion by 2019, according to a new report.
Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, but more work is needed to improve patient safety, according to 2 reports released by the Centers for Disease Control and Prevention (CDC).
Low-risk Medicare patients entering home healthcare and receiving a telephonic medication therapy management (MTM) consultation by a pharmacist were three times less likely to be hospitalized within the next 2 months, while those at greater risk saw no benefit, according to a study in Health Services Research.
Antidiabetic drugs are considered to be first-line treatment options for individuals with type 1 and type 2 diabetes mellitus. It is estimated that type 2 diabetes affects about 24 million persons in the United States. Over time high blood levels can lead to complications such as heart disease, kidney damage, or blindness.1 When it comes to the treatment of type 2 diabetes individuals have the option of using oral hypoglycemic agents, compared to individuals with type 1 diabetes that requires insulin therapy.
FDA has approved naloxone hydrochloride injection (Evzio; Kaléo, formerly Intelliject) for emergency treatment when opioid overdose is known or suspected because of respiratory and/or central nervous system depression.
FDA approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
The U.S. Preventive Services Task Force (USPSTF) found that pregnant women who are at high risk for developing pre-eclampsia can take a low dosage of aspirin daily to help prevent the condition, and this can result in better health outcomes for both the mother and the baby.
Critically ill patients requiring mechanical ventilation in an intensive care unit (ICU) may be at increased risk of a new psychiatric illness and medication use following hospital release, according to a report published March 19 in JAMA.
Adult Americans lack sufficient information about the safety of vaccines and the risks of failing to vaccinate for highly contagious diseases, according to a survey released by the National Consumers League.
Compared to a combination of heparin and a glycoprotein (GP) IIb/IIIa inhibitor, use of bivalirudin (Angiomax) is associated with significant absolute reductions in risk for cardiac death and major non-coronary artery bypass graft (CABG) bleeding, according to data presented at the American College of Cardiology 63rd Annual Scientific Session (ACC.14), in Washington, D.C.
Results of 5 phase 3 studies evaluating evolocumab (AMG 145), an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood, were presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), in Washington, D.C
Sandoz this week introduced its calcipotriene and betamethasone dipropionate ointment in the United States. It will be the first generic version of Leo Pharma’s Taclonex ointment in the market.
FDA has approved non-prescription esomeprazole 20mg (Nexium 24HR, Pfizer).
In a study recently published in Nursing 2014, atrial fibrillation patients on warfarin therapy who self-tested their coagulation (via international normalized ratio [INR]) and were remanaged by their clinicians using a “Management by Exception” protocol had better warfarin control than traditional self-testers.1 The protocol, in which patients followed specific clinic-issued, written instructions for managing out-of-range INR self-test results within a predetermined safety range, also benefited clinics by reducing the need for telephone follow-up and related costs.
Poor adherence to prescription drug regimens has long been seen as a substantial roadblock to achieving better outcomes for patients. Data show that as many as half of all patients do not adhere faithfully to their prescriptions, and the result is more than $290 billion spent each year on avoidable medical treatment.
With total healthcare costs in the United States approaching $3 trillion, and costs for a wide range of drugs approaching nearly 15% of healthcare costs overall, or $450 billion, the industry is shifting toward a new emphasis focused on drug formularies.
FDA actions in brief, fast-track designation, orphan drug designation, first-time generic approvals
Influenza vaccination reduced children’s risk of pediatric intensive care unit (PICU) admission for flu by three-fourths during 2010 to 2011 and 2011to 2012, according to a Centers for Disease Control and Prevention (CDC) study published online March 26 in the Journal of Infectious Diseases.
Idarucizumab (Fab, Boehringer Ingelheim), an investigational humanized antibody fragment being studied as a specific antidote for dabigatran (Pradaxa), reversed dabigatran anticoagulation, even in the presence of elevated dabigatran levels and life-threatening bleeding from severe trauma, in animals, according to a study presented at the American College of Cardiology 63rd Annual Scientific Session (ACC.14), Washington, D.C.
Data from a phase 3 study comparing the low-density lipoprotein-cholesterol (LDLc)–lowering efficacy and safety of alirocumab, an investigational PCSK9 inhibitor, versus ezetemibe in patients not receiving statin or other lipid-lowering therapies was presented at the ACC.14, the American College of Cardiology’s 63rd Annual Scientific Session & Expo in Washington, D.C.
