The FDA has granted Priority Review to the combination of Padcev and Keytruda as a perioperative treatment for muscle-invasive bladder cancer, with a decision expected by Aug. 2026. Phase 3 trial results showed the regimen significantly improves survival outcomes and could become a new standard of care regardless of cisplatin eligibility.
Eli Lilly and Company is acquiring Kelonia Therapeutics for up to $7 billion to expand its genetic medicine portfolio, centered on Kelonia’s in vivo CAR T-cell therapy platform that generates therapies directly inside the patient. The deal is driven by early clinical promise of KLN-1010 in multiple myeloma and aims to overcome manufacturing and access limitations associated with traditional CAR T treatments.
New data from Immunocore show that its bispecific protein, tebentafusp-tebn, demonstrated durable 5-year survival benefit in uveal melanoma, which highlights TCR therapies and ctDNA as emerging tools in oncology.
Expanding natural chemical space may improve AI drug discovery by providing biologically relevant data to generate more clinically impactful therapeutics, says Guillaume Vandenesch, CEO and co-founder of Generare, in this exclusive interview.
Merck’s Enflonsia (clesrovimab) has been approved by the European Commission for RSV prevention in infants. The long-acting monoclonal antibody is given as a single fixed dose and is supported by Phase 2b/3 and Phase 3 data showing reduced RSV hospitalizations.
The company has identified a new glycan-based AML target that will be used to support the company’s CAR-NK development, which it expects will advance selective immunotherapy strategies in leukemia.
Marengo Therapeutics reported early Phase 2 activity for its invikafusp alfa combination in metastatic breast cancer and highlighted progress across its Selective T Cell Activation Repertoire (STAR) platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting.
A look inside our latest issue of BioPharm International, where we explore how the biopharma industry is leaning into technical innovation while remaining grounded in operational discipline.
Roche plans a Phase III study of Elevidys to generate additional data for European approval and expand access for patients with Duchenne muscular dystrophy. The trial will evaluate efficacy and safety in ambulatory boys, aiming to strengthen clinical evidence and enable broader approval and reimbursement.
Eli Lilly and Company reported that its oral GLP-1 therapy orforglipron met the primary cardiovascular safety endpoint in a Phase 3 trial, while also delivering superior A1C reduction and weight loss compared with insulin glargine. The drug additionally showed a substantial reduction in all-cause mortality in a pre-planned analysis, supporting plans for FDA submission in type 2 diabetes.
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.
Recent breakthroughs in artificial intelligence allow specialized language models to automatically extract critical information from thousands of complex drug labels in minutes instead of days.
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
With the closing of an acquisition, ROIS adds high-potent fill/finish and lyophilization capabilities to support biologics and ADC pipelines, addressing global supply and scalability challenges.
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.
