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.
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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.
Use of investigational reversal agent idarucizumab can allow physicians to focus on other vital aspects of emergency management beyond anticoagulant reversal in dabigatran-treated patients, according to a study published in the New England Journal of Medicine.
Illinois legislators recently approved a pilot program that would place locking devices on some prescription painkillers.
A surprising 50 percent of U.S. drug overdoses are caused by prescription drugs – 22,000 annually – according to a new report, The Facts Hurt: A State-By-State Injury Prevention Policy.
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Novartis’ new injectable drug secukinumab (Cosentyx) showed significant improvements in treating psoriatic arthritis (PsA), according to a new study.
FDA has approved lumacaftor/ivacaftor (Orkambi, Vertex) for the treatment of cystic fibrosis in patients 12 years and older.
After its proposed acquisition of Humana, Aetna is considering bringing its prescription drug management business in-house, which would mean an end to its contract with CVS Health in 2019.
New data from two phase 2 studies showed ceritinib (Zykadia) shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who had received previous treatment with an ALK inhibitor and in those receiving an ALK inhibitor for the first time.
Antibiotics are frequently and often inappropriately prescribed to nursing home residents, according to a new study in JAMA Internal Medicine. These antibiotics pose direct risks to recipients and indirect risks to others residents.
Drug maker Novartis plans to try a new pricing model with some healthcare customers when it launches its heart failure drug LCZ696, an angiotensin receptor neprilysin inhibitor (ARNI).
In a new lawsuit, the U.S. government alleges Novartis paid kickbacks to specialty pharmacies to increase sales of deferasirox (Exjade), which removes excess iron from the blood of patients who receive transfusions, and mycophenolic acid (Myfortic), to prevent rejection of kidney transplants.
The American Society of Clinical Oncology is asking for comments on its ASCO Value Framework, which compares the value of new cancer therapies with established treatments.
Patients with previously-treated metastic colorectal cancer (mCRC) taking regorafenib (Stivarga) experienced progression-free survival of 2.7 months, according to new data presented at the recent ESMO 17th World Congress on Gastrointestinal Cancer 2015 in Barcelona.
A first-in-class antipsychotic that is a selective serotonin inverse agonist (with no dopaminergic, histaminergic, adrenergic, or muscarinic activity) potentially targeting 5-HT2A receptors, improved Parkinson’s disease psychosis (PDP) with demonstrated safety and tolerability, and without worsening motor Parkinson’s, according to data presented in two posters at the 19th International Congress of Parkinson’s Disease and Movement Disorders (MDS), in San Diego.
According to the August issue of Consumer Reports, the overuse and misuse of antibiotics is leading to the strengthening and spread of dangerous infections that are becoming resistant to these drugs. Here are four recommendations Consumer Reports has for the medical community.
Overuse and misuse of antibiotics has led to a public health crisis-a crisis we must pay attention to now, according to a report that will be published in the August issue of Consumer Reports.
FDA has approved Aurobindo’s entacapone tablets USP, 200 mg, the generic equivalent to Novartis’ Comtan tablets 200 mg.
As lipid management in the United States under goes transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) announced a new study to better understand contemporary lipid management as well as the beliefs and attitudes of patient and providers regarding cholesterol, cardiovascular risk assessment, and options for lipid treatments.
While sales of Gilead Science’s popular hepatitis C drug, Harvoni, had been performing well for several months, the trend has reversed of late. Hepatitis C drug Sovaldi, also from Gilead, has also hit some bumps in the road – in both the U.S. and China.
FDA has approved cangrelor (Kengreal, The Medicines Company) for reducing the risk of periprocedural thrombotic events in patients undergoing percutaneous coronary intervention.
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