BioCentury | Feb 11, 2021
Deals

Next up: Galapagos, Gilead turn to second IPF program, Toledo molecules after $5B deal’s third setback

...in December to abandon U.S. development of the headliner of the original deal, JAK1 inhibitor Jyseleca filgotinib, in...
BioCentury | Dec 16, 2020
Deals

Third strike for Jyseleca takes therapy out of play in U.S. as focus of Gilead, Galapagos deal shifts to IPF

...after the August complete response letter for Jyseleca filgotinib...
...it will stop U.S. clinical trials of filgotinib...
...report.TARGETSJAK – Janus kinase Jeff Cranmer Jyseleca, filgotinib (GLPG0634, GS-6034) Gilead...
BioCentury | Nov 3, 2020
Product Development

Nov. 2 Quick Takes: EMA reviewing filgotinib and DBV’s peanut allergy therapy; plus Royalty Pharma-CF Foundation, CARSgen, Karyopharm, Aurinia, Regeneron and Astellas

...By BC Staff EMA reviewing filgotinib for ulcerative colitisGilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG...
...Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) said EMA is reviewing its MAA for Jyseleca filgotinib...
...ITIM domainsXPO1 (CRM1) – Nuclear export (SINE) protein exportin 1 Danielle Golovin Viaskin Peanut (DBV-712) Jyseleca, filgotinib (GLPG0634, GS-6034) Xpovio...
BioCentury | Oct 29, 2020
Product Development

Gilead leaning on cancer deals for growth as filgotinib’s future hangs in the balance

...Gilead has paused enrollment on three late-stage trials of filgotinib  By Virginia Li, Associate Editor As...
...II ankylosing spondylitis and uveitis trials of filgotinib as it awaits its coming meeting with FDA.Filgotinib...
...Janus kinaseTROP2 (TACSTD2; EGP-1) – Tumor-associated calcium signal transducer 2 Virginia Li Gilead Sciences Inc. Jyseleca, filgotinib (GLPG0634, GS-6034)Gilead...
BioCentury | Oct 13, 2020
Product Development

Gilead’s Jyseleca has a leg up over BMS’s Zeposia in biologic-experienced UC patients

...colitis show two oral therapies —Jyseleca filgotinib...
...Sphingosine 1-phosphate receptor 1 Stephen Hansen Jyseleca, filgotinib (GLPG0634, GS-6034) Gilead...
BioCentury | Sep 29, 2020
Financial News

Sept. 28 Quick Takes: Biogen gains $1.4B on aducanumab update; plus Zai, XtalPi, InventisBio, Galecto, Innovent, Galapagos-Gilead, Biocytogen and ACT Accelerator

...sorafenib in an interim analysis. Japanese approval is filgotinib’s...
...Friday the first global approval of Jyseleca filgotinib...
...first orders this week. Paul Bonanos Jyseleca, filgotinib (GLPG0634, GS-6034) D-0502 Galapagos...
BioCentury | Sep 12, 2020
Product Development

Galapagos gains on Phase II win for systemic sclerosis candidate

...month for an NDA for 100 and 200 mg doses of filgotinib to treat rheumatoid arthritis. Filgotinib...
...European biotech with $3.95 billion in cash and $1.1 billion in equity up front (see “Filgotinib...
...Next Big Biotech”). Despite Friday’s bump, Galapagos’ market cap remains below where it was after the filgotinib...
BioCentury | Aug 21, 2020
Regulation

Data Bytes: FDA approving new drugs at rapid clip in 2020

...36 came in mid-September that year.On Wednesday two therapies received complete response letters from FDA: filgotinib...
...Euronext:GLPG; NASDAQ:GLPG); and Roctavian valoctocogene roxaparvovec, a hemophilia A gene therapy from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) (see “Filgotinib...
BioCentury | Aug 19, 2020
Product Development

Filgotinib setback a blow to building franchise around Gilead-Galapagos therapy

...By stephen hansen, associate editor After a surprise setback at FDA for filgotinib in rheumatoid arthritis caused Galapagos to...
...and other autoimmune indications.  Polar Capital’s David Pinniger had a grim outlook for the future of filgotinib...
...either company.TARGETSENPP2 (ATX) – AutotaxinGPR84 – G protein-coupled receptor 84JAK – Janus kinase Stephen Hansen filgotinib (GLPG0634, GS-6034) Galapagos...
BioCentury | Aug 15, 2020
Deals

Scipher tech could fatten Galapagos’ IBD pipeline

...granted Gilead Sciences Inc. (NASDAQ:GILD) worldwide rights to filgotinib...
...submitted an NDA to FDA in December for filgotinib...
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