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FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations
A significant spike in prescription drug costs helped drive healthcare costs for families covered under an average employer's health insurance plan up an estimated 6.3% in 2015, according to the Milliman Medical Index (MMI) report.
CVS Health’s acquisition of Omnicare for $12.7 billion is expected to significantly expand the drug chain’s business in specialty pharmacy, generics and long-term care.
This summer, Amgen and Regeneron Pharmaceuticals/ Sanofi will battle it out in the competitive cholesterol market. Repatha and Praluent, respectively, are expected to be approved by the FDA this summer.
The higher cure rate of treating hepatitis C patients with a combination of ledipasvir and sofosbuvir (Harvoni) led to substantially better work productivity, according to a new study. In fact, improved work productivity and lack of absenteeism could save the United States and 5 European countries more than $3.2 billion a year.
Johnson & Johnson is expanding its reach in the lucrative hepatitis C drug market after announcing it will collaborate with Achillion Pharmaceuticals to develop its HCV drugs.
In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions," including clear statements of a product's approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable.
Health exchange Covered California said it is the first in the United States to adopt benefit design changes to improve access to high-cost specialty drugs.
FDA has approved the first and only 4-times-per-year schizophrenia drug.
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Nonvalvular atrial fibrillation (NVAF) patients taking uninterrupted rivaroxaban or warfarin had a low rate of major bleeding and thromboembolic complications, according to data presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published in the European Heart Journal.
A Hepatitis C patient is suing Blue Cross because the payer will not cover her Harvoni medication. According to the complaint, filed this week in Los Angeles Superior Court by Shernoff Bidart Echeverria Bentley LLP, Blue Cross has arbitrarily chosen to give the treatment only to those patients suffering from the worst stages of liver damage.
The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
The population of Americans who spend more than $50,000 per year on prescription drugs grew 63% in 2014, largely driven by hepatitis C and cancer therapies, according to an Express Scripts report.
Global pharmaceutical manufactures need to invest billions of dollars to prevent antibiotic-resistant “superbugs”, according to Jim O’Neill, an economist leading a UK government review into antimicrobial resistance.
FDA has approved sumatriptan and naproxen sodium (Treximet, Pernix Therapeutics) for the treatment of migraines in pediatric patients.
FDA has approved moxifloxacin (Avelox) for the treatment of patients with plague. Avelox has been approved under the Animal Efficacy Rule, because it was not ethical to conduct human trials.
A large international study, published in Nature Genetics, found that the H58 “superbug” version, which is resistant to multiple types of antibiotics, is now a major global health threat affecting many countries, including Asia and Africa, where typhoid is endemic.
Nearly half of American hospitals aren’t taking key steps to prevent Clostridium difficile infection-despite strong evidence that such steps work, according to a new study published online in Infection Control & Hospital Epidemiology.
Hepatitis C infections are soaring in 4 states because of high rates of opioid abuse, according to a new report from the Centers for Disease Control and Prevention (CDC).
The non-profit Biosimilars Forum was launched in May 2015 to offer credible, sustained, and unbiased education about biosimilars. The founding members of the Biosimilars Forum represent the majority of companies with the most significant US biosimilars development portfolios.
Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing, plus 4 more new therapies approved by FDA.
Oral therapies are revolutionizing the treatment paradigm of multiple sclerosis (MS), offering enhanced dosing and patient compliance, according to new analysis. Frost & Sullivan’s A Product and Pipeline Analysis of the Multiple Sclerosis Therapeutics Market found that recent therapeutic advancements aim at improving the tolerability of existing products, specifically for interferon beta and glatiramer acetate. Developing anti-inflammatory medications has also been a key area of focus.
Antibiotic resistance has grown at an alarming rate over the last few decades. To prevent a post-antibiotic era in which common infections could become lethal, an estimated 20 novel families of antibiotics must be developed in the next 50 years. Political groups in both the U.S. and Europe are each working to promote new development, but there are concerns the results may not come in time.
New data from a fairly sizable, open-label follow-up trial, presented at the 2015 American Transplant Congress (ATC) in Philadelphia, showed a statistically significant 43% relative risk reduction of death or transplant failure in patients receiving the belatacept (Nulojix) FDA-approved dosing regimen.
FDA’s approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.
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