Development

Savara’s inhaled GM-CSF therapy for autoimmune PAP faces delayed review, potentially postponing access to a treatment targeting impaired lung function

PrecisionLife and Ovation.io are partnering to translate multi-omic analyses of GLP-1 receptor agonist use into predictive biomarker tools, with early findings indicating distinct biological drivers of glycemic control and weight loss and supporting development of diagnostic tests to guide treatment selection and clinical trial stratification.

Updated Phase 1/2 data show trastuzumab pamirtecan achieved an objective response rate of around 50% and disease control exceeding 90% in heavily pretreated patients with HER2-expressing recurrent endometrial cancer, with responses observed across varying levels of HER2 expression and duration of response not yet reached.

Verismo will use the funding to advance Phase I programs using NK-inspired signaling approaches to improve persistence and activity of engineered T cells in solid tumors and blood cancers.

At PDA Week this year, industry leaders highlighted the shift to applied AI in bio/pharma manufacturing and quality and compliance, while focusing on real-world implementation, say Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, as they share their insights from the event.

Mirvetuximab soravtansine–carboplatin combination demonstrates strong response rates and manageable safety profile in FRα-positive patients.

Ifinatamab Deruxtecan is a potential first-in-class B7-H3–directed antibody-drug conjugate for this patient population, which currently faces limited treatment options and poor prognosis.

Novo Nordisk intends to apply advanced AI to analyze complex data, improve target identification, and accelerate development of therapies for chronic diseases

In the collaboration, Regeneron and Telix will combine antibodies with targeted radiation to improve tumor selectivity as they aim to enable more precise treatment and response monitoring in oncology.

Through collaboration, Imagene AI and Daiichi Sankyo will apply multimodal AI to improve biomarker discovery with the goals of advancing precision oncology and enhancing clinical trial success rates.

Oricell Therapeutics has raised over $110 million in a pre-IPO round to advance its CAR-T cell therapy platform aimed at treating solid tumors, including liver cancer. The company is developing its lead candidate Ori-C101 and next-generation CAR-T technologies such as in vivo and armored CAR-T, positioning itself to address longstanding challenges in solid tumor immunotherapy.

Alpheus Medical has initiated a phase 2b trial evaluating a novel sonodynamic therapy approach for glioblastoma, with early patient enrollment underway. The investigational PoMA platform aims to improve outcomes by targeting diffuse tumor cells across the brain, addressing a major limitation of current treatments.

Recapping this year’s PDA Week, Kate Malachowski, PhD, and Malav Parikh, the co-chairs of PDA Week 2026, share their insights on how AI and knowledge management are shaping the future of bio/pharma quality.

Astellas taps Dyno’s AI-designed AAV capsid to boost skeletal muscle gene delivery, aiming for lower doses and safer next-gen therapies.

Phase 2 results from Sanofi suggest that lunsekimig could emerge as a novel treatment option for respiratory conditions such as asthma and chronic rhinosinusitis with nasal polyps. The investigational therapy achieved both primary and key secondary goals in two clinical studies, supporting its potential as a dual-target biologic aimed at tackling complex inflammatory pathways.

Subcutaneous Tepezza shows Phase 3 efficacy in thyroid eye disease, achieving 77% response, significant proptosis reduction, and improved patient outcomes.

With $137 million in Series B funding led by Novartis and other firms, Sidewinder Therapeutics will support development of bispecific ADCs designed to improve tumor targeting, enhance drug delivery, and reduce off-target toxicity in cancer.

As 2026 marches forward, the biopharma industry finds itself balancing therapeutic innovation with operational discipline across manufacturing, data integrity, and next-gen precision medicine

Drug development has evolved from a linear, data-driven expectation into a complex, iterative process shaped by scientific uncertainty, modality-specific challenges, and increasing demands for differentiation, real-world value, and reimbursement.

The acquisition aims to advance next-gen ADCs that target NaPi2b and 5T4 and that show early clinical activity in solid tumors, which highlight advances in precision payload delivery and durability.

A disciplined approach is needed to address complexity, limited knowledge, lack of platform processes and standard analytics, and regulatory uncertainty.

Webinar Date/Time: Thu, Apr 30, 2026 11:00 AM EDT

Webinar Date/Time: Tue, May 19, 2026 11:00 AM EDT