Development

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.

Early-phase clinical trials are becoming more complex and data-driven, requiring emerging biotechs to incorporate biomarker strategies, exposure–response analyses, and regulatory planning into Phase I study design while carefully considering CRO selection, operational continuity, and trial geography.

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.

Advanced data strategies and specialist biometrics teams can deliver faster, cleaner insights from Phase I trials and power smarter early drug decisions, says Ben Edwards of Avance Clinical.

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.

Outsourced partners can help innovators make better decisions earlier in development, before uncertainty becomes late-stage risk.

Johnson & Johnson reports encouraging Phase 1b data for its bispecific antibody pasritamig in combination with docetaxel in metastatic castration-resistant prostate cancer, showing strong PSA responses and manageable safety

Utilizing contract development and contract research organizations in drug discovery and development may offer benefits for drug formulators.

Webinar Date/Time: Thu, Mar 19, 2026 11:00 AM EDT

Webinar Date/Time: Fri, Mar 20, 2026 11:00 AM EDT

Webinar Date/Time: Tue, Mar 17, 2026 11:00 AM EDT

Avance Clinical’s Ben Edwards explains how biotechs must design Phase I trials for quantitative exposure–response data to meet current FDA guidance and de‑risk Phase II dose selection.

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.