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The company's first-in-class immune-boosting antibody could become the first approved treatment for a cancer with no existing options.

Amplitude Therapeutics has entered a strategic research collaboration and licensing agreement with Eli Lilly and Company to discover and develop trans-amplifying RNA (taRNA) vaccine candidates for infectious diseases with high unmet need, with Lilly holding an option to add up to two additional targets.

AbbVie's bispecific antibody posted a 90% response rate in squamous NSCLC, headlining the company's expanding lung cancer pipeline data.

Adaptin Bio has opened enrollment in a first-in-human Phase 1 trial of APTN-101, a bispecific T-cell engager built on the company's BRiTE platform designed to cross the blood-brain barrier and target EGFRvIII-positive glioblastoma. The trial, conducted with Duke University, will enroll up to 15 adult patients with WHO Grade IV malignant glioma.

A defensible AI quality framework links intended use, patient and product risk, evidence, human accountability, and lifecycle control, without forcing every use case into the same validation model.

This edition of The BioPharm Brief covers FDA approvals for Pasatru in fibrodysplasia ossificans progressiva and Genglycos in glycogen storage disease type Ia, along with a new bispecific CAR-T entering clinical development for large B-cell lymphoma.

Dr Eric von Hofe of CellxLife and Dr Keith L. Knutson of Mayo Clinic explain why manufacturing speed and cost will determine the scalability of personalized cancer vaccines.

Avexitide cut severe hypoglycemic events 55% in a pivotal PBH trial, positioning it to become the condition's first approved therapy.

Kirsten Detrick, chief representative, USA, at Basel Area Life Sciences Supercluster, discusses why emerging biopharmaceutical companies should incorporate market access and commercial considerations earlier and how Basel’s concentration of cross-functional talent can support product development and launch.

The FDA has approved Genglycos (pariglasgene brecaparvovec-opnr), a one-time AAV8 gene therapy, to reduce cornstarch dependence in patients eight and older with GSDIa, the first approved treatment to target the disease's underlying genetic cause.

AbelZeta Pharma has reclaimed global rights to prizloncabtagene autoleucel from Janssen and secured FDA clearance to begin US trials, positioning the anti-CD20/CD19 bispecific CAR-T for patients who relapse after existing CAR-T therapies.

This week’s BioPharm Brief covers positive phase 3 melanoma results for Merck and Moderna’s individualized neoantigen therapy, a personalized cancer vaccine manufacturing platform entering clinical use, and a new brain-penetrant antibody approach for glioblastoma.

AI tools that extract information from unstructured medical records could help oncology practices identify eligible clinical trial patients, surface care gaps, and compare treatment outcomes across real-world cohorts, according to Shaalan Beg and Eron Kelly of ConcertAI.