Oncology

Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

Exosome-based treatments hold promise, but their reality has not yet materialized in the form of compelling clinical data. Belgian biotech Exo Biologics’ CEO Hugues Wallemacq believes his company can help move the field forward, both through its own clinical programs and by offering high-quality exosomes to others in the field.   

Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Leaders from Eli Lilly and Vertex Pharmaceuticals, 9amHealth, Features Capital, and accelerator PharmStars discussed the convergence of biopharma, medtech and healthtech, and what is needed to achieve health care transformation, in an LSX World Congress USA panel.

Exact Sciences presented new data for its blood-based colorectal cancer screening test, which BTIG analysts say bodes well for the test’s probability to receive US FDA approval. Study results are expected in the first half of 2025.

New data suggest that RP1 could become the therapy of choice in melanoma patients who do not respond to checkpoint inhibitors.    

Newly public company ArriVent BioPharma presented Phase Ib results at WCLC for its kinase inhibitor, which could be the first drug available specifically for hard-to-treat PACC mutations.

Cardio-oncology and cardiotoxicity have come directly into the spotlight following ESC's first consensus guidelines. AI is being used for early risk identification, Philips said during the European Society of Cardiology congress 2024.