Galapagos Loses Potential Ticket To America As Crohns Trial Flops
The company reported the Phase III DIVERSITY trial of Jyseleca did not meet its primary endpoint in Crohn’s disease, closing another path to the US market.
You may also be interested in...
Paul Stoffels On Galapagos’s Turnaround And Making Its Gilead Partnership Work
After scoring a long-term multi-billion dollar deal with Gilead, Galapagos rushed into clinical trials and paid the price. Paul Stoffels talks to Scrip about returning to his Belgian roots and turning around the company he co-founded.
Gilead Gives Up On Galapagos's Filgotinib In RA
A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.
Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan
Galapagos and Gilead's JAK inhibitor has been approved for rheumatoid arthritis in the second and third biggest pharma markets, softening the blow somewhat of rejection from the US FDA in the biggest market last month.