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CordenPharma is expanding its Caponago, Italy site with a €80 million multi-year investment and new aseptic fill-finish lines, aiming to reach 500 million sterile injectable units of annual capacity to meet rising demand across peptide, biologic, LNP, and oligonucleotide-based drug products.

Lundbeck's asedebart, which blocks ACTH signaling at its source, has won FDA orphan status for endogenous Cushingsyndrome.

BIIE CEO Dr Stephen Wilson explains why Basel's condensed innovation ecosystem was chosen for the institute’s translational research mission.

Single-partner platforms promise to replace fragmented prescription hubs with one connected, data-driven journey for manufacturers and patients alike.

The BioPharm Brief highlights Biora Therapeutics’ first human trial of its BioJet oral delivery system, FDA priority review of Roche’s satralizumab for MOGAD, and Encoded Therapeutics’ $275 million financing for its Dravet syndrome gene therapy ETX101.

Solstice Oncology launched with a $225 million Series A financing to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody licensed from Harbour BioMed, into neoadjuvant Phase 2 testing for microsatellite-stable colon cancer.

Biora's BioJet capsule aims to deliver adalimumab without a needle, entering human testing after hitting 51.3% preclinical bioavailability.

Satralizumab cut MOGAD relapse risk 68% in a phase 3 trial, positioning it as the first potential treatment for this rare disease.

Encoded Therapeutics closed a $275 million Series F financing to fund pivotal and expansion studies of ETX101, an AAV9-mediated gene regulation therapy for SCN1A-positive Dravet syndrome, alongside commercial-scale buildout of the company's in-house GMP manufacturing.

Ersodetug missed its phase 3 primary endpoint in congenital HI, but FDA is reviewing CGM data showing 50%+ hypoglycemia reductions.

Amgen and AstraZeneca announced that the Phase 3 DeLLphi-305 trial met its primary endpoint, with Imdelltra (tarlatamab) plus Imfinzi (durvalumab) significantly improving overall survival versus durvalumab alone as first-line maintenance therapy for extensive-stage small cell lung cancer — the first phase 3 study of a bispecific T-cell engager to show a survival benefit in this earlier-line setting.

Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.

HHS announced four senior FDA leadership selections, including Karim Mikhail as permanent Director of the Center for Biologics Evaluation and Research and Michael Davis as Director of the Center for Drug Evaluation and Research, capping more than a year of turnover at both centers.