The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
Benefits of Secukinumab in Ankylosing Spondylitis May Persist at 2 Years
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
U.S. Supreme Court to Hear Dispute Over Biologic Drug Sales
NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…
Pfizer Announces Medicare Reimbursement for Inflectra (infliximab-dyyb), the First Biosimilar Monoclonal Antibody Available in the United States
On Jan. 6, Pfizer Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has included payment information for INFLECTRA (infliximab-dyyb), a biosimilar to REMICADE (infliximab), in its January Average Selling Price (ASP) pricing file. This pricing took effect as of January 1, 2017. Additional claims processing information is listed in the MLN Matters…
Guselkumab Improves Active Psoriatic Arthritis
A study showed that guselkumab may decrease symptoms of psoriatic arthritis and improve quality of life in adult patients…
Rituximab Promising for Dermatitis Herpetiformis
NEW YORK—Rituximab may be an effective treatment for recalcitrant dermatitis herpetiformis (DH), according to a recent case study. “DH is an autoimmune blistering disease which is commonly associated with celiac disease and can present with debilitating pruritic blisters on extensor surfaces,” explained Dr. Ron Feldman of Emory University School of Medicine. “The most common treatments…
FDA Update: FX006 Promising for Knee OA; Pioglitazone Linked to Bladder Cancer Risk; & HIV Drug Gets New Labeling
The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…
New Test Yields Rapid Infliximab Drug Concentrations
NEW YORK (Reuters Health)—A new test provides rapid infliximab drug concentrations that enable immediate dosing adjustments, researchers from Belgium report. “With this rapid test, our biggest wish is to persuade physicians to now perform and use infliximab measurements also in their own daily clinical practice, as many practical and organizational issues that went along with…
U.S. Democrats Seek Trump’s Cooperation on Drug Price Reform
NEW YORK (Reuters)—A group of Democratic senators took their plans to tackle rising drug costs to President-Elect Donald Trump on Tuesday, asking him to work with them and Republicans on the issue. In a letter dated Tuesday, the 19 senators named five areas for cooperation: allowing the Medicare program to negotiate prescription prices, increasing transparency,…
Certolizumab Pegol Usage Compatible with Breastfeeding
In a small-scale study, researchers found that no, or minimal amounts of, certolizumab pegol transfers from mothers taking the drug to nursing infants…
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