Re­gen­eron's pre-filled Eylea sy­ringe makes the FDA cut; Cure­Vac inks pact with Yale

→ As the FDA re­views No­var­tis‘ $NVS ri­val brolu­cizum­ab (set­ting the stage for ap­proval by the end of the year) — the for­mi­da­ble mak­er of Eylea, Re­gen­eron, has man­aged to get a pre-filled sy­ringe ver­sion of the eye treat­ment across the fin­ish line — af­ter an ini­tial re­jec­tion — as it works to for­ti­fy its block­buster fran­chise. Last Au­gust, the FDA al­lowed Re­gen­eron $REGN to start mar­ket­ing a 12-week reg­i­men for Eylea for wet AMD pa­tients, ver­sus the orig­i­nal bi-month­ly reg­i­men. Brolu­cizum­ab is al­so a 12-week reg­i­men, al­though No­var­tis has ar­gued piv­otal tri­al da­ta sug­gests the drug was “con­sis­tent­ly su­pe­ri­or” to its Re­gen­eron ri­val, which gen­er­at­ed more than $4 bil­lion in net US sales last year.

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