Biologic Drugs in Development

GSK’s B7-H3-targeted ADC has shown durable responses in SCLC, supporting regulatory momentum and advancing targeted approaches for high-unmet-need lung cancers.

With the license, Sanofi gains Kali Therapeutics’ tri-specific T-cell engager pipeline candidate, KT501, which targets B cell-mediated autoimmune diseases.

The hub will integrate the company’s manufacturing and R&D in China to streamline CAR-T development while addressing scalability and accelerating regional access to advanced therapies.

With Sanofi as one of its backers, Earendil Labs is set to advance its AI-native biologics platform to scale antibody discovery, accelerate IND filings, and expand partnerships in autoimmune and oncology research.

Phase III data show retatrutide reduces HbA1c and body weight, supporting triple-agonist strategies for metabolic disease treatment.

The launch of Excalipoint Therapeutics brings to the table multi-specific T-cell engager platforms that aim to overcome tumor microenvironment barriers and expand efficacy into solid tumors and immunology indications.

Data from a Phase III trial showed durable survival benefit with PD-L1 blockade plus chemotherapy, reinforcing the use of immunotherapy in curative-intent GI cancer settings.

The current Middle East conflict is disrupting Gulf air and sea hubs, forcing bio/pharma firms to reroute cold-chain drug shipments and raising risks of oncology medicine shortages.

Regulatory acceptance of tildrakizumab's sBLA signals a potential expansion of IL-23 inhibition into joint disease, an area in which treatment gaps persist for a substantial share of psoriatic disease patients.

The companies’ new immunology-driven mAb, which targets an immune-evasion pathway in myeloproliferative neoplasms, is advancing toward first-in-human trials.

The company is targeting the $3 billion pancreatic cancer market with its lead proenzyme therapy candidate, PRP, which is supported by strong preclinical tumor inhibition data and for which a PK assay will be developed and validated.

Results from a head-to-head study highlight cytokine-targeting differences between UCB’s bimekizumab and risankizumab, strengthening evidence for dual IL-17 blockade in psoriatic arthritis therapy

The new clinical data show biomarker reductions and new motor milestones with salanersen, which supports once-yearly antisense therapy development in spinal muscular atrophy.

Data from the MajesTEC-9 Phase III trial shows teclistamab as monotherapy improves survival, indicating a shift in multiple myeloma treatment.

The launch of a new mRNA biotech spinout signals a structural shift in how next-generation RNA therapeutics are developed and commercialized.

In a Phase II trial, Pfizer’s tilrekimig demonstrated well-tolerated, dose-dependent improvements in chronic Th2 inflammation, supporting further clinical development in atopic dermatitis.

Phase III trial results show that trastuzumab deruxtecan reduced invasive recurrence or death 53% in patients with residual HER2-positive disease after neoadjuvant therapy.

China’s approval of Sciwind’s ecnoglutide for weight management, alongside the company’s Pfizer commercialization deal, intensifies competition in the global GLP-1 market.

Updated analysis from the COMPASSION-03 Phase II trial links response depth to survival, which supports PD-1/CTLA-4 bispecific checkpoint strategies in heavily pretreated cervical cancer.

Under the partnership, INOVIO and Akeso will evaluate DNA-encoded tumor antigen priming plus PD-1/CTLA-4 bispecific blockade in an adaptive Phase II trial for glioblastoma.

Data from Novo Nordisk’s UBT251 Phase II trial support triple-receptor metabolic modulation as a strategy to enhance weight-loss efficacy beyond single-pathway incretin therapies.

CGT Catapult’s newly formed advisory board aims to address manufacturing, data, and regulatory constraints influencing scalable development and clinical deployment of ATMPs.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Roche’s termination of the SHIELD DMD trial highlights how recruitment and regulatory feasibility increasingly shape rare disease drug development.

Long-term data from a Johnson & Johnson study show that sustained IL-23 inhibition maintains histologic and endoscopic remission, supporting durability-driven UC drug development strategies.