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.
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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.
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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.
The FDA last week approved Rexulti (brexpiprazole) for schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).
In this blog post, Robert Kyle of AdverseEvents compares the results of a postmarket survey of 3 obesity drugs.
Pregnant women who use antidepressants to manage depression should talk with their doctors for a personalized recommendation on how the antidepressants may affect the pregnancy.
Major safety concerns exist for many top-selling prescription drugs including benzodiazepines/prescription sleep aids, anticoagulants, cholesterol-lowering statins, oxycodone and hydrocodone, and stimulants. The following provides an overview of these classes and issues.
FDA is warning that diazoxide (Proglycem) for low blood sugar has caused pulmonary hypertension (high pressure in the blood vessels leading to the lungs) in infants and newborns.
FDA’s approval last week of AstraZeneca's Iressa (gefitinib) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) is an important tool in fighting the disease.
FDA approved Ipsen Biopharmaceuticals’ supplemental Biologics License Application (sBLA) for abobotulinumtoxinA (Dysport) for the treatment of upper limb spasticity (ULS).
The Healthcare Supply Chain Association (HSCA), the Generic Pharmaceutical Association (GPhA), and other healthcare stakeholders are calling on FDA to institute a clear policy for biologics and biosimilars.
Actavis is voluntarily recalling more than half a million boxes of Lutera birth control pills because of packaging problems.
The FDA this week approved Novartis’s sacubitril/valsartan (Entresto) tablets to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF).
FDA’s approval last week of Vertex Pharmaceutical’s groundbreaking drug lumacaftor/ivacaftor (Orkambi) for cystic fibrosis is certainly good news, but formulary managers need to be aware of the high cost of the drug and other factors.
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