BioBusiness

Precision analytics and flexible manufacturing are helping to advance safer, scalable bispecific antibodies, antibody-drug conjugates, and central nervous system monoclonal antibodies from development to patients.

Novo Nordisk's ziltivekimab failed to reduce cardiovascular events in the phase 3 ZEUS trial despite confirmed IL-6 target engagement.

The EC has approved AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan ADC for 1st-line metastatic TNBC, which showed a 5.0-month overall survival benefit over chemotherapy.

Polpharma Biologics and Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed biosimilar to Takeda's Entyvio (vedolizumab), with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa.

Kelun-Biotech's sac-TMT has gained NMPA acceptance for a new first-line indication application in advanced triple-negative breast cancer.

FDA has granted priority review to Johnson & Johnson's Rybrevant Faspro for head and neck cancer, backed by 42% ORR in the OrigAMI-4 trial.

Aprea Therapeutics CEO Dr Oren Gilad discusses ASCO 2026 data for WEE1 inhibitor APR-1051 and the company's precision oncology strategy while at BIO 2026.

Allogene's cema-cel has received FDA RMAT and fast track designations for first-line consolidation therapy in high-risk large B-cell lymphoma.

FDA staff have questioned RP1's melanoma trial data ahead of a July 30, 2026 advisory committee vote, causing Replimune shares to fall 30%.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Harbour BioMed and Sinopharm have formed a strategic Innovation Consortium to co-develop biologics in oncology and immune-mediated inflammatory disease.

argenx will acquire Forte Biosciences for $2.2 billion, which will add first-in-class anti-CD122 antibody, FB102, to its immunology pipeline.

Johnson & Johnson reported that phase 3 MonumenTAL-6 data show Tecvayli plus Talvey cut the risk of progression or death by 89% in relapsed/refractory multiple myeloma.

Sanofi announced it has discontinued amlitelimab in atopic dermatitis, forgoing global regulatory submissions despite positive long-term phase 3 data.

Repligen will acquire BioLife Solutions for $1.5 billion, adding CryoStor biopreservation media to its cell therapy portfolio.

Ipsen has completed its acquisition of Memo Therapeutics, which adds potravitug, an anti-BKPyV antibody, to its rare disease pipeline.

Phase 3 SHASTA-3/4 trials show plozasiran cut triglycerides up to 81% and reduced pancreatitis events up to 100% in high-risk sHTG patients.

Propanc Biopharma has reported peer-reviewed data on scalable recombinant production of trypsinogen and chymotrypsinogen, supporting a synthetic backup to its lead cancer candidate, PRP.

Under the deal, Lonza will grant Engitix a single-target ADC license for SYNtecan E, GlycoConnect, and HydraSpace to advance ECM-targeted fibrosis and cancer therapies.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

Halozyme and Incyte will advance subcutaneous INCA033989 for mutCALR-positive MPNs, with the aim of improving treatment delivery while supporting targeted clinical development.

The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.

Boehringer Ingelheim has started a phase 2 trial of BI 3034701, an investigational triple GLP-1/GIP/NPY2 receptor agonist for obesity and overweight.

Deck Bio’s Dr Johanna K. Kaufmann spoke at BIO 2026 about how the company’s multi-peptide major histocompatibility complex T cell engager strategy aims to expand patient eligibility and overcome solid tumor heterogeneity and antigen escape resistance.