Data from two phase 3 studies were used to support the FDA’s approval of ixekizumab for adults with ankylosing spondylitis…
Drug Pricing Bills Move Forward
This week, the U.S. House of Representatives released a long-anticipated plan that contains provisions to reduce U.S. drug prices according to an international price index.
FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…
FDA Approves Upadacitinib for RA
Results from multiple phase 3 clinical trails have led to the FDA approval of upadacitinib to treat patients with moderate to severe active RA…
Filgotinib Promising for RA
Research shows filgotinib may be safe and effective for treating rheumatoid arthritis. The drug’s manufacturer is expected to be submit a new drug application for filgotinib to the FDA in 2019…
Trump Administration to Appeal Ruling Blocking Price Disclosure for Drug Ads
(Reuters)—The Trump administration is appealing a court ruling that struck down its plan to compel pharmaceutical companies to disclose wholesale prices of their drugs in televisions advertisements. The U.S. Department of Health and Human Services (HHS) filed a notice of appeal on Wednesday, as it prepares to challenge the July federal court ruling. “If the…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
Otilimab Begins Phase 3 Clinical Studies for RA
In a four-part clinical trial program, researchers are assessing the safety and efficacy of otilimab with placebo in RA patients, along side conventional treatments, such as tofacitinib, and DMARDs…
Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis
Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…
Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel
(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
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