Industry & Policy News

[EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications] Regeneron Pharmaceuticals, Inc. announced that the US FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD^® Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications.

[Italfarmaco S.p.A. (BioSpace)] Italfarmaco S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Duvyzat^®, a novel histone deacetylase inhibitor. The authorization is for the treatment of patients with Duchenne muscular dystrophy aged six years and older who are able to walk, when taken together with corticosteroids.

[QPS (BioSpace)] QPS is pleased to announce the expansion of its pharmacology disease models portfolio to include highly relevant models for metabolic dysfunction-associated steatohepatitis (MASH), ulcerative colitis, wound healing, and psoriasis.

[Johnson & Johnson] Johnson & Johnson announced that the European Commission has approved a Marketing Authorisation for TREMFYA^® for the treatment of adult patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

[Cardiff Oncology] Cardiff Oncology, Inc. announced that the United States Patent and Trademark Office has issued to Cardiff Oncology U.S. patent No. 12,263,173 with an expected expiration date of no earlier than 2043. The patent cover the method of using onvansertib in combination with bevacizumab (bev) in any line of therapy for the treatment of metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.

[Gilead Sciences, Inc.] Gilead Sciences, Inc. announced positive topline results from the Phase III ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy^® plus Keytruda^® significantly improved progression-free survival compared to Keytruda and chemotherapy in patients with inoperable locally advanced or metastatic TNBC whose tumors express PD-L1.