Pharmaceutical Executive Daily: September 17, 2025

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 Lilly’s orforglipron as a prime candidate for FDA fast-track approval, Merck and Daiichi Sankyo’s breakthrough therapy designation for R-DXd in ovarian cancer, and Novo Nordisk’s EU approval of Rybelsus for reducing cardiovascular risk.

Eli Lilly’s oral GLP-1 candidate, orforglipron, has been highlighted as a prime contender for FDA fast-track approval. Analysts point to strong clinical data supporting weight reduction and metabolic benefits, positioning the therapy as a potential blockbuster in the expanding obesity market. If advanced through fast-track status, orforglipron could reach patients more quickly, complementing Lilly’s growing portfolio of GLP-1 treatments and strengthening its leadership in the obesity and diabetes space. The move comes as demand for oral and patient-friendly formulations continues to grow worldwide.

In oncology, the FDA has granted breakthrough therapy designation to Merck and Daiichi Sankyo’s antibody-drug conjugate, R-DXd, for the treatment of platinum-resistant ovarian cancer. The designation reflects promising clinical data suggesting significant benefit in a patient population with limited treatment options. For Merck, this strengthens its partnership with Daiichi Sankyo and its push into ADC innovation, while Daiichi continues to expand its footprint in one of the fastest-growing oncology modalities. Both companies are expected to accelerate development efforts as they prepare for pivotal late-stage studies.

And in Europe, Novo Nordisk achieved a milestone with the approval of its oral GLP-1 therapy, Rybelsus, as the first treatment in the EU shown to reduce the risk of severe cardiovascular events in patients with type 2 diabetes. The approval broadens Rybelsus’ therapeutic profile beyond glycemic control and could drive wider adoption across European markets. With cardiovascular outcomes increasingly central to diabetes treatment guidelines, Novo’s win positions the company strongly against rivals in the GLP-1 class.

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