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Novo Pulls Wegovy Heart Failure Application, Will Resubmit To Get ‘Hard Endpoints’ In Label

 
• By Jessica Merrill and Kevin Grogan

However, Lilly already has outcomes data for tirzepatide, meaning Novo could lose the race to market with a heart failure claim even after being first to the US FDA.

The FDA had some disappointing news for Novo Nordisk. • Source: Shutterstock

Novo Nordisk A/S’s decision to pull its heart failure applications for Wegovy (semaglutide) illustrates that blockbuster drugs can still face challenges with labeling subtleties.

Key Takeaways

  • Novo expects to resubmit semaglutide for a heart failure claim early next year, calling the delay in the hopes of a better label “a really good bargain.”

Incretins, and Wegovy in particular with its obesity and cardiovascular outcomes claims, have been seen as products whose sales are...

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• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
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As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
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AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

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AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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