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.
In the summer of 2021, over 200 biopharma executives were surveyed about their changing approaches to building biologic drug development pipelines. This executive summary presents the findings from this outreach.
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).
Historically, therapies focusing on niche markets face tremendous obstacles, from drug development and clinical trials to drug access. Drew Desjardins – EVP, Chief Strategy Officer, Fishawack Health – analyzes several key challenges for brand marketers readying to launch products in these small markets, along with solutions for driving better stakeholder experiences.
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.
The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.
