LONDON (Reuters)—Britain’s competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade (infliximab) that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) says it had provisionally found the U.S. company’s European unit, Merck Sharp & Dohme (MSD), had abused…
Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval
(Reuters)—Amgen Inc. and UCB SA no longer expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial. The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
Four-Week Methotrexate Break Improves Flu Shot Response in RA Patients
NEW YORK (Reuters Health)—Temporarily withholding methotrexate (MTX) can improve the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA), according to a new randomized clinical trial. Response was strongest in patients who discontinued MTX for two weeks before and two weeks after receiving the flu shot, Dr. Eun Bong Lee of Seoul National…
Rheumatology Drug Updates: Sirukumab Promising for RA, Plus Efficacy Duration of Ustekinumab for Plaque Psoriasis
Sirukumab Promising for RA Sirukumab, an investigational human monoclonal antibody that selectively binds to the interleukin (IL) 6 cytokine, has completed a randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial (SIRROUND-T) in patients with rheumatoid arthritis (RA).1 During the trial, which took place between July 25, 2012, and Jan. 12, 2016, researchers randomized adult patients…
Experimental Drug Combination Curbs Chikungunya Arthritis in Mice
Doctors have had few options to treat the chronic rheumatoid arthritis-like symptoms associated with chikungunya virus infections beyond over-the-counter pain relievers. A recent study in Science Translational Medicine has spurred new optimism by finding that a combination therapy—the anti-rheumatic drug abatacept paired with a chikungunya-neutralizing monoclonal antibody—abolished acute symptoms in infected mice.1 The strategy must…
FDA Approves Oral Methotrexate; Plus Restrictions for 2 Analgesics in Children
The FDA has approved a new formulation of methotrexate designed as an oral solution for pediatric patients. The agency has also recently introduced age restrictions for codeine and tramadol for children under age 12, citing their risks for slowed or difficult breathing and death…
Rheumatologists Respond to Prescription Opioid Analgesic Crisis
The alarming statistics on prescription opioid overdoses are well known to medical professionals, thanks to the Centers for Disease Control and Prevention (CDC)’s widely cited finding that deaths from opioid analgesics have increased fourfold since 1999.1 Half of all fatal drug overdoses now involve opioids prescribed by a doctor. Meanwhile, a lack of rigorous research…
Pembrolizumab May Induce Sarcoid-Like Skin Reactions
NEW YORK (Reuters Health)—Eruptive keatoacanthomas and extensive panniculitus are among the dermatological conditions associated with the anticancer agent pembrolizumab, researchers say. Pembrolizumab, a humanized IgG4 PD-1 (programmed cell death-1) antagonist antibody, is an immune checkpoint inhibitor (CPI) approved in the U.S. for treating advanced melanoma, non-small-cell lung cancer and head and neck squamous cell carcinoma….
Pricey Arthritis Drug Effective in Small Fraction of Ulcerative Colitis Cases
NEW YORK (Reuters Health)—Pfizer’s expensive arthritis drug tofacitinib has been shown to produce a remission in nearly 1 in 5 patients with moderate to severe ulcerative colitis, but long-term remission persists in fewer than half of those cases. In a series of studies published in the May 4 New England Journal of Medicine, researchers reported…
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