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Eisai, Gilead Enter Exclusive Agreement for JAK Inhibitor Filgotinib in Asia contractpharma
December 22, 2021
Eisai obtains exclusive marketing right for filgotinib in South Korea, Taiwan, China, Hong Kong, S.A.R., China and Singapore and will take over manufacturing and marketing.
Galapagos’ filgotinib leads to rapid symptom improvement for ulcerative colitis patients pharmatimes
July 13, 2021
A post-hoc analysis from a Phase III clinical programme evaluating Galapagos’ filgotinib showed significant symptom improvements for patients with ulcerative colitis (UC).
EMA begins evaluation of filgotinib for ulcerative colitis pharmatimes
November 05, 2020
Gilead and Galapagos’ application seeking approval for their oral JAK1 inhibitor filgotinib as a treatment for ulcerative colitis has been validated by the European Medicines Agency (EMA).
Gilead’s oral JAK inhibitor filgotinib wins EU approval pharmatimes
September 30, 2020
Gilead Science’s Galapagos-partnered oral JAK inhibitor filgotinib has been approved by the European Commission under the brand name Jyseleca for the treatment of moderate-to-severe active rheumatoid arthritis (RA).
US FDA declines approval for Gilead’s rheumatoid arthritis drug, Filgotinib expresspharma
August 20, 2020
The US drug regulator has issued a complete response letter requesting data from the MANTA and MANTA-RAy studies and expressing concerns regarding the overall benefit/risk profile of the drug.
Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderate pharmaceutical-business-review
May 27, 2020
Gilead Sciences and Galapagos announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily ...
Gilead Submits Filgotinib NDA for Rheumatoid Arthritis Treatment americanpharmaceuticalreview
December 24, 2019
Gilead Sciences has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the ...
Filgotinib Bests Placebo in Tx of Refractory Rheumatoid Arthritis drugs
July 24, 2019
Among patients with moderately to severely active rheumatoid arthritis (RA) resistant to previous therapy with biologic agents...
Galapagos and Gilead announce positive Phase III results for filgotinib pharmaceutical-technology
April 23, 2019
Galapagos and Gilead announce positive Phase III results for filgotinib.