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…
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…
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…
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…
FDA to Review Immediate-Release Oxycodone; Plus NICE Recommends Secukinumab
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
Baricitinib Approval Stalls; Plus No REMS for Erythropoiesis-Stimulating Agents
The FDA has declined to approve baricitinib to treat rheumatoid arthritis, citing the need for more data on dosing and safety…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
Nevada Rheumatologists Take on Biologic and Biosimilar Substitution
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…
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