LEO Plays Up Rapid Action Of Picato For Actinic Keratosis
This article was originally published in The Pink Sheet Daily
Executive Summary
Newly approved plant-based gel works in just a few days of treatment, rather than the weeks required for some competitors.
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New Irritable Bowel Disease And Burn Therapies Among Those Recommended By Europe’s CHMP
Bayer’s aflibercept, Leo’s ingenol mebutate, Almirall’s linaclotide and a proteolytic enzyme concentrate, Teva’s NexoBrid, were given positive opinions on their marketing by CHMP on Sept. 21, with Almirall taking a different approach to linaclotide’s development than that taken in the U.S.
CDER Approvals In January Came Early And Often
FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.
NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate
With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.