Bio/Pharma Outsourcing Innovation eBook February 2025

Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.

Part 2 of the VK2735 maintenance study tests whether daily or weekly oral tablets can hold weight loss first achieved with weekly subcutaneous injections.

CSL and Alentis will co-develop lixudebart, an antibody targeting claudin-1, across 3 rare kidney and liver disease indications.

AL050 aims to treat GBA1-driven Parkinson disease by delivering a GCase enzyme across the blood-brain barrier.

Survodutide advances metabolic disease treatment, while biosimilar capacity expands, FDA delays hemophilia review, and lupus data support next steps.

Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.