Tags : Galapagos

M&A

Selvita to Acquire Fidelta from Galapagos for ~$37M

Shots: Selvita to acquire 100% of the outstanding shares in Fidelta for $37.08M + customary adjustments for net cash & working capital The acquisition will expand Selvita’s integrated drug discovery services offering with the addition of Fidelta Fidelta will be fully consolidated under Selvita Group & will continue to operate under the Fidelta name. Fidelta […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

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, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, […]Read More

Clinical Trials

Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION

Shots: The P-llb/lll SELECTION study comprises two induction trials and a maintenance trial. Both induction studies involve assessing of filgotinib (200/100 mg) vs PBO in a ratio (2:2:1) in adult patients with moderately to severely active UC Induction study result: In biologic-naïve patients (200mg dose), clinical remission @10wks. (26.1% vs 15.3%); MCS remission (24.5% vs […]Read More

Pharma Regulatory

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion

Shots: The 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 FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage […]Read More

Biotech Clinical Trials

Gilead and Galapagos Report Results of Filgotinib in P-IIb/III SELECTION

Shots: The P-IIb/III SELECTION study involves assessing of filgotinib (200/ 100mg) vs PBO in 1,348 biologic-naïve & biologic-experienced patients in a ratio (2:2:1) with mod. to sev. UC. The SELECTION study consists of 2 induction trials and a maintenance trial Filgotinib (200mg) achieved all its 1EPs inducing clinical remission @10wks. in biologic-naïve & experienced patients […]Read More