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Novo Nordisk AS

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Latest From Novo Nordisk AS

Should US Insulins Be Treated As Biologics?

Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.

Regulation Biosimilars

US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Drug Approval Standards Post Market Regulation & Studies

Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.

Review Pathway Regulation

Novo Nordisk, Bluebird Targeting ‘Lifelong’ Gene Therapies

Novo Nordisk and bluebird bio will jointly develop genome editing treatments for genetic diseases, beginning with hemophilia.
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