Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease
Withdraws US Marketing Submission
Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.
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Ipsen Eyes Opportunity In Rare Liver Diseases With Albireo Buy
The French firm is paying a 104% premium plus contingent value rights of an additional $10 per share to get hold of AstraZeneca spin-off Albireo and its lead asset Bylvay, which is approved for progressive familial intrahepatic cholestasis and is showing promise in two other more lucrative indications.
Zejula, Revatio Advisory Committee Meetings Cancelled; Palovarotene Panel Postponed
Panel to review overall survival data on GSK’s Zejula for ovarian cancer ‘is no longer needed,’ US FDA says. Meeting to consider pediatric indication for Viatris’ Revatio was also cancelled though sNDA remains active. FDA to review new information on Ipsen’s palovarotene clinical trial data.
Ipsen To Exit Consumer Health And Focus On Specialty Pharma
The French group is sharpening its focus on specialty care