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 in EU for Jyseleca (200/100mg) in RA and UC + all future indications for which Gilead will receive royalties on EU sales initiating in 2024 Galapagos to receive $194.6M, which […]Read More
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
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
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 for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely […]Read More
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
Shots: The company has reported the first patient dosing in the P-I CALOSOMA study assessing the safety, tolerability, PK/PD of GLPG3970 single & multiple ascending doses in up to 52 adult healthy male subjects. The therapy will now be evaluated in 25 patients with moderate to severe psoriasis for 6wks. Galapagos is also evaluating the […]Read More
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
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
The 2020 JP Morgan Healthcare Conference was loaded with insights from key pharma companies. An analysis of events and catalysts that were announced or updated at the conference these days are included. Our PharmaShots team summarized the key deals which were presented during the updates from companies from Jan 13 to Jan 16, 2020. Date […]Read More
Shots: Fibrocor to receive upfront, option exercise fee, milestones and royalties on sales of the product. Galapagos to receive an exclusive option to in-license up to 4 targets, out of which two reached the lead optimization stage Galapagos takes an equity stake in Fibrocor and will get an exclusive global right to commercialize the developed […]Read More
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