Friday, October 19, 2012

Reuters: Regulatory News: EU agency backs Novo's new insulin, Lilly imaging agent

Reuters: Regulatory News
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EU agency backs Novo's new insulin, Lilly imaging agent
Oct 19th 2012, 11:54

LONDON | Fri Oct 19, 2012 7:54am EDT

LONDON Oct 19 (Reuters) - Novo Nordisk's ultra long-lasting insulin Tresiba has been recommended for approval for the European Medicines Agency in an important boost for the Danish drugmaker's key new product.

The European endorsement, announced by the London-based agency on Friday, comes after the treatment hit regulatory delays in the United States.

Tresiba, or degludec, is central to Novo's aim of ending Sanofi's dominance of the long-acting insulin market.

The regulator also recommended a new Alzheimer's imaging agent from Eli Lilly, the first radiopharmaceutical for PET imaging of beta-amyloid plaques, which are found in the brains of patients with the disease.

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