Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…
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….
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…
Subcutaneous CT-P13 Injection Evaluated for Safety & Efficacy of in RA Patients
Results from a one-year study suggest subcutaneous CT-P13, which is biosimilar to infliximab, is as safe and effective for RA patients as intravenous (IV) CT-P13 and IV infliximab…
Ixekizumab vs. Adalimumab for PsA: How Do They Compare?
In a study of bDMARD-naive patients with active PsA and skin disease, ixekizumab proved more efficacious than adalimumab…
FDA Approves Risankizumab, Adds Stronger Warning to Sleep Medications
The FDA has approved rizankixumab to treat adults with plaque psoriasis and added boxed warnings to sleep medications…
British Columbia Will Be First Canadian Province to Switch Patients to Biosimilars
TORONTO/MONTREAL (Reuters)—The Canadian province of British Columbia said on May 28 that its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars, saving an estimated C$96.6 million ($71.9 million) over three years. The new policy from the province’s PharmaCare program targets Johnson & Johnson’s…
Ixekizumab Promising for Non-Radiographic Axial SpA; Plus FDA Approves Belimumab for Pediatric Lupus
Results from a Phase 3 study showed ixekizumab significantly improved the signs and symptoms of non-radiographic axial spondyloarthritis in patients…
Common Characteristics in RA Patients Who Don’t Respond to Biologics
At least 6% of patients who used biologic disease-modifying anti-rheumatic drugs (bDMARDs) suffered refractory disease, according to a recent study based on data from the British Society for Rheumatology Biologics Registry for Rheumatoid Arthritis.1 This observational study evaluated the extent of biologic refractory rheumatoid arthritis (RA). The study defined biologic refractory disease as occurring in…
IV Meloxicam Stalls at FDA; Plus Health Canada Approves Risankizumab for Plaque Psoriasis
In a second response letter, the FDA has cited the onset and duration of intravenous meloxicam, a non-opioid pain treatment, as concerns that it fails to meet prescriber expectations…
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