The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
NEW YORK (Reuters Health)—The oral Janus kinase inhibitor tofacitinib (Xeljanz, Pfizer) shows long-term efficacy against chronic plaque psoriasis, according to findings from two randomized studies and an extension trial. The outcome, Dr. Svitlana Tatulych told Reuters Health by email, “demonstrated that oral tofacitinib, at both the 10 mg and 5 mg twice-daily doses, provided sustained…
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
New research indicates that vaccination for the herpes zoster virus in patients with rheumatoid arthritis starting tofacitinib appears to be both safe and useful. Rheumatologists may want to check the patient’s pre-existing immunity status prior to administering the vaccine…
WASHINGTON (Reuters)—The U.S. Senate on Monday moved closer to confirming Dr. Robert Califf to lead the U.S. Food and Drug Administration, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move designed to prevent the opponents from blocking the confirmation indefinitely, the Senate voted 80 to…
A recent Phase 3 clinical trial found apremilast safe and effective for treating patients with active psoriatic arthritis and skin symptoms who found conventional and biologic DMARDs ineffective…
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
(Reuters)—Amgen Inc. and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study. The topline results, from a Fracture study in postmenopausal women with osteoporosis (FRAME), showed that the drug romosozumab met a…