The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Regeneron Pharmaceuticals in Tarrytown, New York, are partnering to develop a novel Ebola virus treatment.
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FDA announced new requirements for the monitoring, prescribing, and dispensing of clozapine, an atypical antipsychotic for treatment-resistant schizophrenia, due to the continued risk of severe neutropenia, which can be life-threatening.
While biosimilars’ savings will not reach the historically high level achieved for small-molecule generic drugs, the impact on the healthcare industry will still be significant, according to a new report.
Joint FDA advisory committees voted 23-1 against approving Purdue Pharma’s immediate release opioid painkiller Avridi last week.
FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.
FDA approved aspirin extended release capsules (Durlaza, New Haven Pharmaceuticals, Inc.) for the prevention of stroke and acute cardiac events.
The FDA has strengthened its warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density.
Alynlam Pharmaceuticals and The Medicines Company reported positive initial results from their ongoing Phase 1 clinical trial with their injectable cholesterol-lowing drug, ALSN-PCSsc, at the ESC Congress 2015 held in London, August 29 – September 2.
Healthcare providers, celebrities, patients and others are helping to increase awareness of idiopathic pulmonary fibrosis (IPF) during the Pulmonary Fibrosis Foundation’s (PFF) Pulmonary Fibrosis Awareness Month.
Pre-exposure prophylaxis (PrEP) may prevent HIV infection, according to a study published in Clinical Infectious Diseases. It is one of the first and largest published evaluations of the use of PrEP to prevent HIV infection in a clinical practice setting.
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FDA has approved rolapitant (Varubi, Tesaro) for the prevention of chemotherapy-induced nausea and vomiting.
Rituxan (rituximab) has a consistent safety profile through multiple courses over 11 years of observation, according to a new long-term study published in the online edition of The Journal of Rheumatology.
The first biosimilar drug approved by FDA in March was officially launched in the United States on September 3 – at a value compared to competing medications.
FDA warned this week that several leading drugs for type 2 diabetes may cause severe and disabling joint pain. FDA said that sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain, and added a new Warning and Precaution about this risk to the labels of all dipeptidyl peptidase-4 (DPP-4) inhibitors.
Pharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.
FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes.
FDA has expanded approval of eltrombopag (Promacta, Novartis) to treat low blood platelet count in pediatric patients with chronic immune thrombocytopenic purpura.
Fortune describes the 5 fastest-growing US pharmaceutical manufacturers.
4 things formulary managers can do to save lives and resources.
FDA’s approval of the first 3D-printed pill – Spritam to control epileptic seizures – will have a major impact on the medical and pharmaceutical community as a whole.
FDA’s long-awaited approval of Addyi (flibanserin) to treat hypoactive sexual desire disorder in premenopausal women, is significant for the prescribing community.
Jardiance is the first diabetes drug that has also been shown to lower strokes, heart attacks and cardiovascular deaths, according to a new study.
FDA has approved sNDA for new formulation of fentanyl buccal soluble film (Onsolis, BioDelivery Sciences International) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.
While FDA is proposing that bevacizumab (Avastin) for macular degeneration be used within 5 days of re-packaging to avoid development of endophthalmitis in patients, that precaution may not be necessary, according to a new study.
FDA recently granted special approval of pediatric use of OxyContin in patients aged 11 to 16 years, under specific conditions.
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.
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