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Novo Nordisk AS

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Latest From Novo Nordisk AS

Quality Experts Advise Industry To Move Products To Local Sites In Responding To COVID-19

Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.

Manufacturing Quality

Novo Nordisk Halts Phase III Concizumab Hemophilia Trials After Three Thrombotic Events

No new patients will be enrolled, and trial participants will stop treatment with the tissue factor pathway inhibitor antibody, a class with four prior suspended hemophilia programs.

Clinical Trials Drug Safety

The Last Days Of NDAs: Uncertainties Remain Ahead Of 23 March Move From Drugs To Biologics

Exactly how many NDAs ultimately will make the switch, the impact of pending applications on 'Orange Book' listings, and the ramifications for ‘authorized generics’ are areas of focus as the regulatory transition date looms.

Biosimilars Biologics

Medicare’s Insulin Demo Project Likely Depends On Plan Interest

Manufacturers are on board for ‘Part D Senior Savings Model’ that would set a $35 copay cap, but added risk corridor payments may be the key to getting PBMs to offer the enhanced plans focused on reducing insulin costs for patients.

Pricing Debate Medicare
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