Eisai and Biogen completed the rolling submission of a Biologics License Application for their proposed Alzheimer’s disease drug to the U.S. Food and Drug Administration.

Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.

Y-mAbs Therapeutics Inc. announced that the company completed the resubmission of its Biologics License Application (BLA) for 131I-omburtamab to the U.S. FDA.

The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.

Pharma giant AbbVie and Iceland-based Alvotech settled a case filed with the International Trade Commission. The dispute centered around Alvotech’s adalimumab biosimilar drug, which AbbVie posited had been developed through theft of trade secrets of the company’s Humira product.

The U.S. Food and Drug Administration accepted for review Pfizer Inc.’s Prior Approval Supplement to the Biologics License Application for ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

FDA

Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.

Provention Bio is resubmitting a Biologics License Application (BLA) for teplizumab, a drug intended to delay the onset of Type 1 diabetes (T1D) in at-risk individuals, following a Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.

Lilly announced that mirikizumab, the company’s monoclonal antibody formulation to treat ulcerative colitis (UC), met the primary endpoint of clinical remission and all key secondary endpoints at one year in a Phase III maintenance study.

Lexington, Mass.-based Agenus withdrew the company’s Biologics License Application (BLA) for the PD-1 inhibitor balstilimab from the U.S. Food and Drug Administration.