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Amylin’s Bydureon Approval: How Does It Sit With Novo Nordisk?

 
• By Wendy Diller

Sponsor of the leading GLP-1 agonist, Victoza, sees the launch of the long-acting competitor from Amylin as having a class-wide impact, drawing more patients to GLP-1s – and it thinks that it can stave off the once-weekly contender.

Competitors see the U.S. approval of Amylin Pharmaceuticals Inc.’s type 2 diabetes drug Bydureon (long-acting exenatide) on Jan. 27 as an event that will boost interest in the entire GLP-1 class, benefiting other agents as well.

Novo Nordisk AS has come out swinging in the wake of Amylin’s long-time-coming success, and it will be interesting to see if the chief differentiating points for Bydureon, convenience and better tolerability, can help it gain share against Victoza (liraglutide). Novo’s highly successful GLP-1 agonist had sales of more than $1 billion in 2011

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UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.