Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market
This article was originally published in The Pink Sheet Daily
FDA advisory committee scheduled for Valentine’s Day is key test for Guerbet’s efforts to get its MRI imaging agent a wider indication than Bayer’s Gadavist.
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The gadolinium-based contrast agent should be approved for use in adults and older pediatric patients, but more data are needed to support a novel indication for children under two years old, the Medical Imaging Drugs Advisory Committee says.
In advisory committee briefing documents, agency reviewers cite limitations in gadoterate’s pediatric experience, particularly among patients two years of age and younger. This is the key population that would differentiate Dotarem from other gadolinium-based contrast agents already on the market.
An NME Surge After The Patent Cliff? Reinvention Of R&D Starts Paying Off In 2013 New Product Candidates
With almost 40 novel agents already pending at FDA, 2013 looks like a good bet to repeat the strong NME and novel biologic approval counts of 2012 and 2011. Big pharma and big markets dominate the 2013 slate so far, especially with diabetes, respiratory and central nervous system candidates.