FDA recently granted special approval of pediatric use of OxyContin in patients aged 11 to 16 years, under specific conditions.
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A study of tocilizumab (Actemra) in the treatment of rheumatoid arthritis (RA) found that the number of serious adverse events (SAEs) found in postmarketing data were similar to other populations from clinical trials and epidemiology data.
Novo Nordisk is expected to find out in October whether FDA will approve its long-acting insulin Tresiba for sale in the US market. However, if approved, Tresiba faces growing competition from Sanofi, which markets the leading basal insulin Lantus along with Toujeo.
A Medicare reimbursement policy proposing that multiple biosimilars have the same pricing J-code for Medicare reimbursement purposes could ultimately result in fewer treatment options, according to a group representing the industry.
Surprisingly, giving prescriptions to the wrong patients is still common in community pharmacies across the U.S. According to the Institute for Safe Medication Practices (ISMP), this error occurs about once in every 1,000 prescriptions dispensed.
FDA has approved azelaic acid (Finacea, Bayer HealthCare) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
Pharmaceutical firms “underinvest” in long-term research to develop new cancer-fighting drugs because of the time and expense, according to a new study.
FDA approved epilepsy drug levetiracetam (Spritam), the first FDA-approved drug that utilizes three-dimensional printing (3DP).
Unichem Pharmaceuticals issued a voluntary recall of Hydrochlorothiazide Tablets 25 mg, 1,000-count bottle. The precautionary measure is due to the identification of a Clopidogrel tablet found in a bottle at one pharmacy.
Global sales of pharmaceuticals will soar to $1.3 trillion in 2018, led by new cancer and specialty drug introductions, a new report found.
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FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).
After positive phase 3 trial data for its treatment for the bleeding disorder von Willebrand disease, Baxalta Inc. is awaiting FDA approval for the drug.
FDA has granted priority review to naloxone nasal spray (Indivior) for the treatment of opioid overdose. If approved, naloxone nasal spray is expected to be the first FDA-approved intranasal naloxone product indicated to treat opioid overdose in the United States.
There have been 8 high-profile FDA approvals in the last few weeks. Here is an overview.
On July 24, FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections.
FDA has approved sonidegib (Odomzo, Novartis) for locally advanced basal cell carcinoma.
Misconceptions about antibiotic use persist and continue to be more prevalent among parents of Medicaid-insured children, according to a study published in Pediatrics.
FDA has approved ombitsavir, paritaprevir and ritonavir (Technivie, AbbVie) for the treatment of hepatitis C virus genotype 4 infections.
With FDA’s approval of Praluent (alirocumab) injection, the first in a new class of injectable cholesterol-lowering drugs called PCSK9 inhibitors, comes the need for a utilization management approach.
AbbVie on July 24 reported weaker-than-expected revenue for its most recent quarter, which some analysts say is due to increased competition for its anti-inflammatory drug, Humira.
FDA has granted CLIA waiver for the Alere i Strep A test. The test, which was cleared for marketing by FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less.
The current global Parkinson’s disease market is characterized by a number of unmet needs, which include addressing the motor complications of dyskinesia and off-episodes. The recent approval of novel therapies and reformulations of existing drugs has the potential to fulfill some of these unmet needs, particularly in patients with advanced disease.
FDA has granted CLIA waiver to Theranos for herpes simplex virus test and test system.
Patients with moderate to severe atopic dermatitis (AD)-or eczema-may be successfully treated using a rheumatoid arthritis (RA) drug recently shown to reverse 2 other skin conditions, vitiligo and alopecia areata, according to findings published early online in the Journal of the American Academy of Dermatology.
In this blog response to the July 13 article "5 reasons to keep biosimilar names the same," Louis Tharp, executive director or Global Healthy Living Foundation, lists 5 reasons biosimilars must have distinguishable names.
On July 7, the FDA updated its list of drugs that are in short supply. Some of the drugs – such as Sodium Chloride 0.9 percent Injection Bags – have been in short supply for months, while others have become more problematic recently.
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