Tags : Galapagos

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

Galapagos Signs an Exclusive Option to License Agreement with Fibrocor

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

PharmaShots Weekly Snapshot (October 28 – November 01, 2019)

1. Medtronic Reports MHLW’s Shonin Approval and Launches Valiant Navion Thoracic Stent Graft System in Japan Published: Oct 31, 2019 | Tags: Medtronic, Reports, MHLW, Shonin Approval, Launches, Valiant Navion Thoracic Stent Graft System, Japan  2. Beam Therapeutics Signs Exclusive License Agreement with Prime Medicine for Prime Editing Technology Published: Oct 31, 2019 | Tags: Beam […]Read More

PharmaShots Weekly Snapshot (August 12-16, 2019)

Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for Ablation of Prostate Tissue Published: Aug 16, 2019 | Tags: 510(k), Ablation, Clearance, Profound Medical, Prostate Tissue, Receives, TULSA-PRO, The US FDA 2. Mallinckrodt Reports Positive Results of Terlipressin in P-III CONFIRM Study for Hepatorenal Syndrome Type 1 Published: Aug 16, 2019 | Tags: CONFIRM, Hepatorenal Syndrome […]Read More

Gilead and Galapagos Reports the Validation of EMA’s MAA for

Shots: The MAA is based on P-III FINCH studies assessing Filgotinib (qd) in patients with RA resulted in improvements in clinical signs & symptoms, low disease activity and remission, inhibition of structural damage for different sub-populations The EMA will review Filgotinib filing under the centralized licensing procedure for all 28 member states of the EU […]Read More

Gilead to Raise Stake in Galapagos with ~$5.1B Deal

Shots: Galapagos to receive $3.95B upfront and $1.1B equity investment. Gilead to get rights of Galapagos’ GLPG1690 for IPF, option rights of GLPG1972 for OA in the US and option rights of all Galapagos’ current and future clinical programs (Ex-EU) Gilead has an option for GLPG1972 and will pay $250M license fee, $200M post to […]Read More