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
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
Shots: The discontinuation of a clinical program is based on an interim analysis for futility in P-II IGUANA study which demonstrated low probability to meet 1EPs i.e, the percentage change in EASI score The clinical development program of MOR106 includes two P-II IGUANA & GECKO studies, P-I bridging study for SC formulation and Japanese ethno-bridging […]Read More
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
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
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
Shots: The P-III FINCH-3 study involves assessing of filgotinib (100/200 mg) + methotrexate (MTX) vs filgotinib (200mg)/MTX as monothx in 1252 patients in ratio (2:1:1:2) with moderate to severe active RA who are naive to MTX for @24 wks. P-III FINCH 3 results: ACR20 (80.2%, 81.2% vs 78.1%/71.4%); ACR50 (57%,61.5% vs 58.1%/ 45.7%); ACR70 (40.1%, […]Read More
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