Shifting the Biomanufacturing Paradigm - Intensifying Upstream Processes

Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.

Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.

Insulin efsitora alfa-gobe (Onswik) cuts injections from 365 to 52 a year for adults with type 2 diabetes, per its new FDA approval.

Genentech is paying Earendil Labs $55 million upfront in a deal worth over $1.5 billion to develop bispecific antibodies for hard-to-treat cancers.

Acuitas CEO Dr Thomas Madden and NanoVation co-founder and president Dr Dominik Witzigmann discuss how LNP engineering is expanding genetic medicine applications to traditionally undruggable targets.

Guselkumab eased spinal pain, stiffness, and MRI-confirmed spinal inflammation in a 411-patient trial of psoriatic arthritis with axial involvement.

AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.