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Latest From Novo Nordisk A/S

ERC Not Giving Up On Glioma Immunotherapy In EU

ERC Belgium has pledged to collect more data to convince the European Medicines Agency that Sitoiganap merits approval. Meanwhile, UGA Biopharma said it would address the agency’s objections over its biosimilar version of eptacog alfa.

Drug Review Regulation

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: a US setback for UCB; Lilly challenges Novo’s GLP franchise; Seagen searches for CEO after scandal; Hengrui hopes for US PD-1 success; and a look ahead at ASCO.

Commercial Executive Changes

PTC Confident About Commercial Prospects For Gene Therapy Upstaza

PTC CEO Stuart Peltz tells Scrip that cost watchdogs are likely to look favorably on the firm’s transformational gene therapy for a distressing rare brain disorder in children who could not even lift their heads before treatment.

Gene Therapy Drug Review

Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

Commercial Clinical Trials
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