Paul Stoffels swiftly resurfaces as Galapagos’ next CEO
Paul Stoffels’ retirement at the end of last year after nine years as head of R&D at Johnson & Johnson was short lived – he’s […]
Paul Stoffels’ retirement at the end of last year after nine years as head of R&D at Johnson & Johnson was short lived – he’s […]
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jyseleca (filgotinib) 200mg tablets to treat ulcerative colitis (UC) in adults whose UC is […]
After 22 years at the helm of Belgian biotech Galapagos, chief executive Onno van de Stolpe has decided it is time to retire and hand […]
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | […]
Galapagos has had to send its SIK inhibitor programme back to the drawing board after its lead compound GLPG3970 has failed two of three clinical […]
Shots: The P-III SELECTION trial comprises 2 induction trials & a maintenance trial evaluating filgotinib (200/100 mg) vs PBO in adult patients with active UC […]
Episode 35 of the pharmaphorum podcast hears from Michael Smyth about Galapagos UK and joining the company as medical director just as COVID-19 hit. With […]
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, […]
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common […]
Gilead and Galapagos’ much-trumpeted R&D alliance has suffered another setback with the abandonment of ziritaxestat after a late-stage failure in idiopathic pulmonary fibrosis (IPF). Ziritaxestat […]
Shots: The P-III program consists of two trials (ISABELA 1 & 2) assessing ziritaxesta (200/ 600mg, qd) + SOC vs PBO + SOC in ~1500 […]
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the […]
Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed […]
Shots: Following the FDA Type A meeting, Gilead will not pursue the approval of Jyseleca for RA in the US. Galapagos will be solely responsible […]
Shots: Selvita to acquire 100% of the outstanding shares in Fidelta for $37.08M + customary adjustments for net cash & working capital The acquisition will […]
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, […]
Shots: The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA […]
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval […]
The FDA has rejected Gilead and Galapagos’ rheumatoid arthritis (RA) pill filgotinib over concerns that it could damage male fertility, prompting speculation that the big […]
Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three […]
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