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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.

Regeneron Pharmaceuticals' garetosmab-grts has become the first approved therapy to shrink new bone lesions in FOP, cutting them by up to 94% as it targets the disease's root biology directly.

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.

Real-time process analytics and digital manufacturing systems could generate the reliable data needed for artificial intelligence to deliver more predictive insights in biopharmaceutical manufacturing, according to Bryan Hassell, founder and CEO of Nirrin Technologies.

Merck and Moderna report that the personalized mRNA plus mAb cancer therapy cleared its first phase 3 hurdle, cutting recurrence risk beyond pembrolizumab alone.

NTx Bio's NTxscribe CORE platform is being used by Baylor College of Medicine to manufacture mRNA for DOC1021, Diakonos Oncology's personalized dendritic cell vaccine, now dosing patients in a Phase 1 trial for refractory melanoma.

Today’s BioPharm Brief looks at a long-acting anti-VEGF therapy entering clinical trials, the first commercial use of imlifidase in Australia for kidney transplantation, and FDA Fast Track designation for a platelet-derived biologic for chronic sciatica.