Shots:Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other marketsIn the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…
Shots:The EC has approved Tremfya to treat mod. to sev. active UC adults with inadequate response, no response or intolerance to SoCs or biologics; CHMP recommendation under EC review for mod. to sev. active Crohn’s disease with decision anticipated later 2025 Approval was based on P-IIb/III (QUASAR) trial assessing Tremfya (IV induction: 200mg Q4W;…
Shots:Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…
Shots:Jennifer talked about the results from QUASAR Induction Study-I evaluating Tremfya in adults with moderately to severely active ulcerative colitis presented at the 2022 American College of Gastroenterology Annual MeetingHe also gave an overview of Trefmya focusing on major advances. He also spoke about the epidemiology and etiology of Ulcerative ColitisThe interview…

