Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Ipsen Positive On Palovarotene Despite Troubled Past

Filings For FOP In Early 2021

Executive Summary

Despite concerns over toxicity due to early growth plate closure in skeletally immature patients, Ipsen's CEO David Loew is confident that palovarotene will get through regulatory review for fibrodysplasia ossificans progressive.

You may also be interested in...



Ipsen’s Palovarotene Ultra-Rare Bone Disorder Drug Faces Hurdles At US FDA Adcomm

Agency questions whether post hoc analyses and use of natural history subjects as an external control group in a Phase III study support effectiveness of palovarotene; cites apparent increased incidence of flare-up events as a key safety issue.

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC143467

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel