The BioPharm Brief: Weekly Insulin, Excipient Data, and the Fate of a Lung Cancer ADC

Welcome to The BioPharm Brief, your daily snapshot of the latest developments shaping biopharmaceutical research, regulatory progress, and drug development. Today’s update covers a new once-weekly insulin option for type 2 diabetes, efforts to standardize excipient information sharing, and a regulatory setback for an antibody-drug conjugate in small cell lung cancer.

First, FDA approved Eli Lilly and Company’s Onswik as a once-weekly basal insulin for adults with type 2 diabetes. The approval is supported by a phase 3 program that enrolled more than 3400 participants across 4 registration studies. Onswik achieved noninferior A1C reductions compared with daily insulin glargine or insulin degludec. By reducing basal insulin injections from roughly 365 to 52 per year, the therapy could change how some patients manage long-term insulin treatment. It is not indicated for type 1 diabetes because of an increased risk of severe hypoglycemia.

Shifting from clinical development to pharmaceutical manufacturing, another initiative focuses on improving how excipient information moves between suppliers and drug manufacturers. The International Pharmaceutical Excipients Council’s Excipient Information Package, or EIP, provides a standardized framework for sharing quality, regulatory, supply-chain, and security information. The approach is intended to reduce the need for companies to complete multiple customer-specific questionnaires while helping suppliers provide consistent information more efficiently.

Meanwhile, the oncology pipeline saw a regulatory setback. Daiichi Sankyo and Merck voluntarily withdrew their FDA application for ifinatamab deruxtecan, or I-DXd, in previously treated extensive-stage small cell lung cancer after discussions with FDA indicated that phase 2 data did not support accelerated approval. The companies continue enrolling patients in a phase 3 trial, which could provide data for a future filing.

Collectively, these stories show how biopharma progress depends on advancing patient-friendly therapies while strengthening the technical and regulatory processes supporting development.

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Key takeaways

• Weekly insulin could reduce treatment burden for adults with type 2 diabetes.
• Standardized excipient data sharing may improve pharmaceutical supply-chain efficiency.
• Daiichi Sankyo and Merck continue evaluating ifinatamab deruxtecan after withdrawing its SCLC filing.