This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|September 18, 2013
GSK Responds to Patent Ruling Reversal on Lovaza
Author(s)Melanie Sena
GSK reported that the Court of Appeals has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza.
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The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico.
Lovaza remains available, and GSK is not aware that FDA has approved any generic versions to date.
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The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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