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….
Drug Assistance Programs Offer Little Charity to Uninsured
(Reuters Health)—Many patients who receive assistance from charities set up to defray prescription drugs costs may already have insurance that covers most the cost for their medications, a U.S. study suggests. Researchers examined data on the six largest independent charities offering patient assistance programs through 274 different disease-specific programs. These programs had total revenue ranging…
Baricitinib: Early vs. Late Treatment Outcomes in RA Patients
Recent research found that RA patients who began treatment with baricitinib experienced greater improvement from baseline than patients who began treatment with methotrexate…
Secukinumab: The Real World Experience of PsA Patients
Secukinumab therapy proved safe and effective for psoriatic arthritis patients with multiple co-morbidities and long treatment histories, according to recent research…
Samsung Bioepis Humira Biosimilar Wins FDA Approval
(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
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