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.
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.
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.
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
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.
CGT is rapidly transforming oncology and rare disease research, with patient-derived models, advanced imaging, CRISPR/Cas9, and 3D organoids driving innovation while solid tumor modeling remains a critical frontier.
New phase 3 data from AstraZeneca suggest that adding systemic agents to embolization can significantly delay disease progression in early hepatocellular carcinoma.
Indirect comparison data from Novo Nordisk show oral semaglutide achieved greater HbA1c reduction and weight loss than Lilly’s orforglipron.
Experts from Acuitas, Mana.bio, NanoVation, and ReCode share their input on targeted LNP engineering, which is accelerating pipeline expansion of nucleic acid therapies for chronic and rare diseases beyond the liver.
FDA approval of a denosumab (Prolia) biosimilar and dual filing acceptances by FDA and EMA for an omalizumab (Xolair) biosimilar candidate from Teva signal increasing competition in the biosimilar markets as well as expanded access for allergy and immunology patients.
Christopher Locher, PhD, CEO, Versatope Therapeutics, discusses how emerging vaccine platforms are advancing the pursuit of a universal influenza vaccine, while highlighting the scientific, regulatory, and economic barriers that continue to shape its path to reality.
