As useful stand-ins for biologics targeting a range of inflammatory diseases, biosimilars have made significant inroads across Europe as less expensive alternatives. Denmark, for example, realized a cost savings of 64% after instituting a mandatory national switch from the originator infliximab to its biosimilar counterpart. In the U.S., however, a considerably smaller fraction of rheumatologists…
FDA Approves Celecoxib in an Oral Solution
The FDA has approved a 25 mg/mL dose of an oral solution of celecoxib to treat adults with acute migraine…
Influential Lancet Article on HCQ Retracted
NEW YORK, June 4 (Reuters)—Three of the authors of an influential article that found hydroxychloroquine (HCQ) increased the risk of death in COVID-19 patients retracted the study, citing concerns about the quality of the data behind it. The anti-malarial drug has been controversial in part due to support from U.S. President Donald Trump, as well…
2 Pediatric Indications Sought for Golimumab
The FDA is reviewing supplemental Biologics License Applications for golimumab to treat polyarticular JIA and juvenile PsA…
Longer Rituximab Therapy Boosts Remission in ANCA-Associated Vasculitis
NEW YORK (Reuters Health)—Long-term rituximab use lowers the chance of relapse of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV), compared with standard maintenance therapy, according to a report from the MAINRITSAN3 randomized trial. “Physicians should consider AAV to be a long-lasting, chronic disease which requires maintenance therapy,” says Dr. Pierre Charles of Cochin Hospital, Paris…
Hydroxychloroquine Combination Risky for Cancer Patients with COVID-19
CHICAGO (Reuters)—Cancer patients with COVID-19 who were treated with a drug combination promoted by U.S. President Donald Trump to counter the coronavirus were three times more likely to die within 30 days than those who got either drug alone, U.S. researchers reported on May 28. The preliminary results suggest doctors may want to refrain from…
U.S. Insurers Often Limit Biosimilar Coverage
(Reuters Health)—U.S. commercial health plans only covered biosimilar treatments as preferred products in 14% of coverage decisions last year, according to an analysis of publicly available data on coverage decisions.1 Researchers examined records from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database, which has information on coverage decisions made by 17 of…
Long-Term Biologic Use May Not Raise Melanoma Risk
NEW YORK (Reuters Health)—Patients treated with biologic therapy for rheumatoid arthritis, inflammatory bowel disease and psoriasis don’t appear to be at increased risk of melanoma, according to the results of a systematic review and meta-analysis. However, because the study found trends toward increased melanoma rates with long-term therapy, “a clinically meaningful increase in risk cannot…
WHO Expects HCQ Safety Findings by Mid-June
ZURICH (Reuters)—The World Health Organization (WHO) on Tuesday promised a swift review of data on hydroxychloroquine (HCQ), probably by mid-June, after safety concerns prompted the group to suspend the malaria drug’s use in a trial on COVID-19 patients. U.S. President Donald Trump and others have pushed HCQ as a possible coronavirus treatment, but the WHO…
Hydroxychloroquine Tied to Increased Risk of Death in COVID-19 Patients
(Reuters)—Malaria drug hydroxychloroquine (HCQ), which U.S. President Donald Trump says he has been taking, is tied to increased risk of death in COVID-19 patients, according to a study published in The Lancet.1 The registry analysis, which included data from 671 hospitals in six continents and over 96,000 patients hospitalized with COVID-19, showed that people treated…
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