Gilead Sciences Inc. and partner Galapagos NV said only a higher dose of their experimental drug filgotinib showed greater effectiveness than placebo in a pivotal study testing it in ulcerative colitis patients.
Despite concerns about potential competition from recently approved and available European biosimilars to Humira, AbbVie was able to stave off some of the losses expected during Q2 2019.
Bristol-Myers Squibb Co., which is set to buy biotechnology company Celgene Corp. for $74 billion, posted better-than-expected second-quarter 2019 earnings on strong sales from the blood thinner Eliquis and the rheumatoid arthritis treatment Orencia.
The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira.
High Dose of Pfizer’s Xeljanz Raises Red Flag in a Post-Marketing StudyAnkylosing Spondylitis (AS), Blockbusters, Drug Safety Concerns, FDA, FDA/Regulatory, Janus Kinase (JAK) Inhibitors, Juvenile Idiopathic Arthritis, Postmarket Studies, Priority Review, Psoriatic Arthritis, Rheumatoid Arthritis, Therapeutics, Tumor Necrosis Factor (TNF) Inhibitors
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz has been a strong performer for the company, bringing in $1.77 billion in revenue last year, but now the company has indicated it intends to make a change in a post-marketing study due to safety concerns.
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The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
Novartis is taking a treatment for persistent hives into Phase III trials after a mid-stage trial showed that the medication, ligelizumab (QGE031), outperformed Xolair in patients with chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines.
Europe approved a fifth copy of AbbVie’s $18-billion-a-year biologic Humira – the world’s best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs.
AbbVie faces a crunch moment in Europe in mid-October 2018 when less-expensive copies of the U.S. drugmaker’s $18-billion-a-year biologic drug Humira – the world’s best-selling prescription medicine – hit the market.
Amgen announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis.