FDA approved tavaborole (Kerydin, Anacor Pharmaceuticals) topical solution, 5%, which is the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.
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FDA approved coagulation factor VIIa [recombinant] (NovoSeven RT, Novo Nordisk), for the treatment of Glanzmann’s thrombasthenia, a rare genetic bleeding disorder.
Adverse reactions to antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulant drugs are responsible for almost 90,000 emergency department (ED) visits each year by US adults, according to a study in JAMA Psychiatry.
Drug overdose deaths in the United States increased for the 11th consecutive year in 2010, according to an analysis from the Centers for Disease Control and Prevention (CDC) and. continued to rise in 2011, the most recent year for which data were available.
Individuals with a large waist circumference may face a higher risk of developing chronic obstructive pulmonary disease (COPD), according to a study published July 7 in CMAJ (Canadian Medical Association Journal).
Postoperative antibiotics after cholecystectomy (gallbladder surgery) do not reduce the risk of infection, according to a study published in the Journal of the American Medical Association.
In adult patients with type 2 diabetes inadequately controlled on metformin monotherapy-the current standard of treatment- canagliflozin (Invokana) 100 mg and 300 mg reduced relative risk for myocardial infarction (1.6% and 3.0%) and congestive heart failure (2.7% and 4.0%), as compared to sitagliptin 100 mg, according to findings of the health economic simulation analysis presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco.
There are some risks associated with some childhood vaccinations, but overall the evidence shows that vaccines are very safe, according a study published in the July 1 online edition and the August print issue of Pediatrics.
In response to rising compounding drug costs, pharmacy benefit managers, such as Express Scripts, have made moves to restrict their coverage for active ingredients used by compounding pharmacies.
The cost and time commitment to develop new drugs has increased significantly over the last few decades. A variety of factors come into play, but on average, in terms of total expenditures, it has taken from $3 to $5 billion and up to 15 years to bring a new drug to market. Even after all that time and money, with challenging regulatory requirements and other factors, the odds of a new compound making it from the lab to the pharmacy are miniscule. The chance for a new drug to make it to market is a sobering 1 in 5000.
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FDA drug approvals, priority review, breakthrough designation, fast-track designations, orphan drug designations, first-time generic approval
Patients with diabetic macular edema (DME) treated with aflibercept Injection significantly improved vision and reduced the severity of diabetic retinopathy versus laser photocoagulation, according to data recently presented the American Diabetes Association (ADA) Scientific Sessions in San Francisco.
The management of bladder cancer represents one of the most costly and underestimated challenges in the oncology spectrum. Despite having the 6th highest incidence of any cancer in the United States, high recurrence rates and the need to constantly monitor patients act as the primary drivers for the high expenditures associated with the disease.
Chemotherapy-induced nausea and vomiting (CINV) is among the most feared adverse effects associated with cancer treatment.1 The likelihood of patients experiencing this entity depends on both patient-related and treatment-related factors. Not all chemotherapeutic products induce equivalent amounts of CINV resulting in the formation of groups contingent on the frequency of CINV in patients receiving a product without antiemetic prophylaxis
The Centers for Disease Control & Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that when available, the needle-free, nasal flu vaccine (Live Attenuated Influenza Vaccine [LAIV]) should be used for healthy children aged 2 to 8 years, who have no contraindications or precautions.
The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
FDA approved insulin human Inhalation Powder (Afrezza, MannKind), a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.
By 2018, specialty drug expenses will comprise 60% of all drug spend, 3 times more than 2014, according to Prime Therapeutics 2014 Report on prescription drug cost analysis.
Lifestyle factors may help predict whether people will adhere to statin therapy for high cholesterol, according to a study published in CMAJ (Canadian Medical Association Journal).
FDA has approved antibacterial drug tedizolid phosphate (Sivextro, Cubist Pharmaceuticals to treat adults with skin infections.
Teen suicide attempts went up about 22% after FDA warned about dangers of antidepressants, according to a study published in the June 18 BMJ.
FDA is requiring manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).
In pregnancy, first trimester use of antidepressants does not substantively increase the risk of specific cardiac defects in babies, and should not be an important consideration in the treatment decision, according to a study published in the June 19 issue of the New England Journal of Medicine.
An extended-release formulation of topiramate (Qudexy XR, Upsher-Smith Laboratories) has been shown to be sale and effective in refractory epilepsy patients in a global phase 3 clinical trial.
American Diabetes Association Scientific Sessions in San Francisco, showed that investigational, non-insulin, once-weekly dulaglutide 1.5 mg provided significant blood glucose control for patients with type 2 diabetes.
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