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.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, after an inadequate response or intolerance to TNF blockers.
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.
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.
Novartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological 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.
Pfizer Inc. announced that the supplemental New Drug Application for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis, has been accepted for filing by the U.S. Food and Drug Administration.
Britain’s AstraZeneca said it had licensed a potential medicine for inflammatory diseases to Allergan for an upfront payment of $250 million and potential additional payments of up to $1.27 billion.