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.
Novartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
Gilead Sciences and Google/Alphabet’ Verily Life Sciences teamed up to focus on three inflammatory diseases: rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases.
Shares of South Korea-based Celltrion were down more than 5 percent after the company announced it received a warning letter from the U.S. Food and Drug Administration after the regulatory agency inspected a company drug manufacturing facility.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.
Merck & Co. reported profit ahead of Street estimates on strong sales of its cancer drug Keytruda, but total revenue fell in third-quarter 2017 from disruptions due to the NotPetya cyber attack and loss of market share for many of the company’s older drugs.
Incyte Corporation will have an abstract published at the European Society for Medical Oncology (ESMO) meeting in early September with new and updated data from its ongoing Phase I/II trial of epacadostat in combination with Merck & Co.’s Keytruda in advanced melanoma.