As Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.
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FDA recently expanded the use of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals) to treat cystic fibrosis in children aged 6 to 11 years who have two copies of the F508del mutation.
FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.
NIH-funded study shows less diabetic retinopathy progression among those who underwent intensive glycemic control.
IMS Health study: Up to 15% of healthcare system costs avoidable and effective patient activation by multiple stakeholders is key to driving improvement.
FDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month.
FDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014.
FDA approved once-daily Yosprala (Aralez), a fixed-dose combination of aspirin, an anti-platelet agent and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.Here are the top 5 facts to know about Yosprala.
Even though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.
FDA’s approval of a new biosimilar-the third FDA-approved biosimilar-stands to save the US healthcare system millions of dollars.
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Despite offering a generic version of its EpiPen, Mylan has been unable to curb the backlash that began in late August over the cost of its epinephrine injection.
FDA recently approved the only oxycodone with oral abuse-deterrent features.
Healthcare spending for people with diabetes rose nearly 6% in 2014, according to a new study. Find out what contributed to the rise.
UK study: Diabetes increases risk of heart attack death. Here are the surprising details.
After protests by patients, parents and Congressional representatives, Mylan said it would offer discounts on its epinephrine EpiPen Auto-Injector treatment to stop allergic reactions.
FDA recently granted Breakthrough Therapy Designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for suicide.
PCSK9 inhibitors such as alirocumab (Praluent, Sanofi) and evolocumab (Repatha, Amgen) are priced too high to benefit the US healthcare system, according to a new study.
FDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.
In an era when legislators, pharmacy benefit managers and others continue to protest the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed. FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
Merck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.
When Express Scripts and CVS Health announced their 2017 formularies on August 1, a common theme emerged among the healthcare giants: several blockbuster drugs will be removed from both companies’ formularies and lower-cost options such as biosimilars are being embraced.
A senator is investigating whether Medicare's prescription drug benefit is vulnerable to manipulation by pharmaceutical companies after an exclusive Associated Press report showed that Medicare’s spending on certain drugs soared by 85 percent.
FDA added new safety labeling changes for a class of antibiotics, fluoroquinolones (Levaquin, Cipro and other branded drugs), to enhance warnings about their association with disabling and potentially permanent side effects. Plus, the new labeling says that the drugs’ use should be limited in patients with less serious bacterial infections.
FDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).
Mayo Clinic researchers found that beyond overtesting, focus on HbA1C levels can lead to serious harms for patients, especially as more diabetes drugs are needed to keep HbA1C within desired targets.
A large-scale observational study led by Columbia University researchers may offer new approach to studying diverse patient groups.
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