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FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More

Michele B. Kaufman, PharmD, BCGP  |  January 18, 2017

The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…

Psoriatic Arthritis Linked to Increased Heart Disease Risk

Carolyn Crist  |  January 17, 2017

(Reuters Health)—Arthritis that accompanies the skin condition psoriasis may also come with a higher risk of heart problems, according to a Hong Kong study. In particular, patients with psoriatic arthritis may have a three- to four-fold higher prevalence of coronary atherosclerosis. Clinicians need to identify patients with high cardiovascular (CV) risk so they can provide…

Do Fevers Offer Insight into Diagnosis & Disease?

Karen Appold  |  January 17, 2017

Patients experience fevers for many reasons, but can they help physicians diagnose disease? Using modern technology and social media, Jonathan S. Hausmann, MD, is working to further the understanding of body temperatures…

Step Therapy, Biosimilars among ACR’s 2017 State-Level Priorities

Kelly Tyrrell  |  January 17, 2017

Opportunities and challenges will continue to face the rheumatology community in 2017. In response to these challenges, the ACR has outlined its federal– and state-level legislative and regulatory healthcare priorities for the year. Howard Blumstein, MD, chair of the ACR Affiliate Society Council, says that achieving at least some of these priorities at the state…

Trump Vows ‘Insurance for Everybody’ in Replacing Obamacare

Reuters Staff  |  January 17, 2017

WASHINGTON (Reuters)—U.S. President-elect Donald Trump aims to replace Obamacare with a plan that would envisage “insurance for everybody,” he said in an interview with the Washington Post published on Sunday night. Trump did not give the newspaper specifics about his proposals to replace Democratic President Barack Obama’s signature health insurance law, but said the plan…

Benefits of Secukinumab in Ankylosing Spondylitis May Persist at 2 Years

Reuters Staff  |  January 17, 2017

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…

Stronger Malpractice Laws May Not Prevent Surgical Complications

Lisa Rapaport  |  January 15, 2017

(Reuters Health)—More aggressive malpractice climates don’t necessarily protect patients from surgical complications, a new study suggests. Supporters of medical malpractice laws that make it easier for patients to sue doctors say these protections are necessary to improve care. But in the current study, the risk of litigation didn’t translate into better outcomes, said study leader…

U.S. Supreme Court to Hear Dispute Over Biologic Drug Sales

Andrew Chung  |  January 15, 2017

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

Pfizer  |  January 13, 2017

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

Michele B. Kaufman, PharmD, BCGP, & Lara C. Pullen, PhD  |  January 11, 2017

A study showed that guselkumab may decrease symptoms of psoriatic arthritis and improve quality of life in adult patients…

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