Pharmaceutical Executive Daily: Novo Nordisk Resubmits BLA for Awiqli

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s resubmission of its BLA for Awiqli, the FDA’s approval of Kedrion’s Qivigy for primary humoral immunodeficiency, and Eli Lilly’s decision to halt development of a muscle-preserving weight-loss therapy.

Novo Nordisk has resubmitted its biologics license application to the FDA for Awiqli, its investigational weekly insulin. The company withdrew the filing earlier this year after the agency requested additional information on manufacturing and quality controls. With the resubmission, Novo aims to move forward with its first weekly insulin, a therapy that could reduce the burden of daily injections for millions of people living with diabetes. Analysts see the program as strategically important, both for expanding Novo’s diabetes portfolio and for maintaining its leadership in metabolic health innovation.

Meanwhile, Kedrion Biopharma has received FDA approval for Qivigy, the first treatment in the United States specifically indicated for adults with primary humoral immunodeficiency. The therapy, administered subcutaneously, offers a new option for patients who require regular immune globulin replacement to prevent serious infections. Physicians welcomed the approval, noting that Qivigy’s profile provides both clinical benefits and potential quality-of-life improvements for individuals managing lifelong immune deficiencies. For Kedrion, the approval marks a significant milestone in expanding its U.S. footprint.

And finally, Eli Lilly has halted a clinical study of its experimental weight-loss drug designed to preserve muscle mass in patients with type 2 diabetes. The company made the decision after early results failed to show the expected benefit. While Lilly remains a dominant player in the obesity and diabetes space with drugs like Zepbound and Mounjaro, the halt reflects the complexity of balancing weight reduction with muscle preservation. Industry observers say the discontinuation will sharpen Lilly’s focus on advancing its broader GLP-1 and obesity pipeline, even as competition intensifies.

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