On March 22, 2017, Ewa Olech, MD, testified at a hearing before the Nevada State Assembly to voice support for A.B. 245, a bill governing biologic medications and biosimilar substitution in that state. She spoke on behalf of the Rheumatology Association of Nevada (RAN), as its president and founder. The bill establishes guidelines regarding biosimilars and requires…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
Insufficient Evidence Regarding Osteoporosis Medications in Kidney Patients
NEW YORK (Reuters Health)—There are insufficient data to make evidence-based decisions regarding the benefits and harms of osteoporosis medications in patients with chronic kidney disease (CKD), according to a systematic review and meta-analysis. “We found low to moderate evidence for the effects of some but not all of the medications, and the evidence was limited…
Ustekinumab Has Longer Efficacy Duration than TNFIs for Plaque Psoriasis
When compared with TNFIs, ustekinumab demonstrated a longer drug survival rate in patients with severe plaque psoriasis…
When Starting Biologics for RA, Disease Severity Predicts Likelihood of Remission
NEW YORK (Reuters Health)—After starting biologic therapy for rheumatoid arthritis (RA), patients with higher disease activity at baseline achieved greater improvements in measures of disease activity than those with lower levels of disease, but they were less likely to achieve remission or even low disease activity, according to a new real world analysis of registry data….
As Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
LONDON (Reuters)—European drugmakers, faced with increasing competition from cut-price copies of complex biotech drugs, cautioned doctors on Thursday to take care when switching patients from an established product to biosimilar version. The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But…
Brodalumab Approved for Plaque Psoriasis
Brodalumab has received FDA approval for treating plaque psoriasis in adults, with a Boxed Warning against prescribing it for patients with a history of suicidal thoughts or behavior…
Infliximab Use Not Tied to Malignancy in Pediatric IBD
NEW YORK (Reuters Health)—Immunosuppressive therapy with infliximab (Remicade) for inflammatory bowel disease (IBD) in pediatric patients is not associated with increased risk of malignancy or hemophagocytic lymphohistiocytosis (HLH), according to a Janssen study. Dr. Jeffrey S. Hyams, who worked on the study, calls the finding “reassuring.” He adds in an email to Reuters Health, “our…
ACR Releases New Position Statements on Site of Service & Compounding
Patient Safety & Site of Service for Biologics Although emphasizing its strong support for the use of biologic agents as necessary treatments for rheumatic diseases, the ACR Board of Directors continues to be concerned about the safe delivery of these agents, given the potential for associated adverse events and infusion reactions. In a position statement…
Certolizumab Pegol Promising for Plaque Psoriasis in Phase 3 Trial
Certolizumab pegol has proved safe and effective for treating patients with plaque psoriasis in a Phase 3 clinical trial…
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