Latest

CNS monoclonal antibody therapies demand rigorous screening and monitoring to ensure patient safety in MS, NMOSD, and Alzheimer disease.

Today's BioPharm Brief explores three distinct ways researchers are engineering the immune system, from a first-in-human bispecific T-cell engager for ovarian cancer and the FDA's first regulatory T-cell immunotherapy to promising vaccine data against antibiotic-resistant Shigella.

92Bio, Inc. has dosed the first patient in a Phase 1 trial of NTB-928, a fully human bispecific T-cell engager targeting FOLR1 and CD3, designed to selectively kill FOLR1-overexpressing ovarian cancer cells while sparing normal tissue — addressing a key limitation of prior FOLR1-directed therapies in platinum-resistant ovarian cancer.

BIO 2026 highlighted biotech's resurgence through M&A dealmaking, CDMO diversification, and renewed investor confidence in biopharma development.

A phase 2 controlled human infection trial has found that two doses of WRSs2, a live-attenuated oral vaccine candidate against Shigella sonnei, achieved 89% protection — the highest efficacy reported for any Shigella vaccine candidate — with no serious adverse events, advancing a century-long quest for a licensed vaccine against the diarrheal pathogen.

Speaking at BIO 2026, Kasper Øland, Samsung Biologics' vice president of sales execution, emphasizes how complex molecules now exceed 55% of the company’s pipeline as biotechs demand faster, more flexible CDMO partnerships.

FDA reported that the PRECISION-T trial showed 78% chronic GVHD-free survival at 1 year versus 38.4% with standard transplant and granted the approval to Orca Biosystems, making the therapy the first Treg cell–based therapy in blood cancers.

At BIO International Convention 2026, Sara-Jane Demy discusses improving biotech investment, renewed NIH support for emerging companies, and why capital access remains one of the industry's biggest priorities.

From a potential first at home treatment for thyroid eye disease to progress in lymphoma and a first in class antibody entering the clinic for kidney fibrosis, today's BioPharm Brief highlights three developments advancing biologic drug development.

The biopharmaceutical landscape grows increasingly complex, and competition for experienced engineering talent has intensified accordingly. For professionals with advanced expertise, evaluating potential employers involves assessing innovation capabilities, organizational culture, career trajectory opportunities, and tangible contributions to healthcare advancement.

The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.

In biopharmaceutical environments, specialized liquid formulation ingredient sourcing choices shape development timelines, production continuity, regulatory readiness and commercial performance.

The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.