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Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome - Vimarsana News

Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome

Published: October 23, 2023

Positive opinion from Committee for Medicinal Products for Human Use recommending approval of Bylvay® (odevixibat) based on Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) already received in July 2023Committee for Orphan Medicinal Products confirms a negative opinion of its review recommending not to maintain the orphan designation for Bylvay in ALGSIpsen plans to submit a new Marketing Authorisation Application for the treatment of ALGS by the end of 2023 under a new brand nam

Source: yahoo.com
Related Topics:
United StatesFrance GeneralUnited KingdomJennifer MooreIoana PiscociuChristelle HuguetAmy WolfAsia PacificNicolas BoglerIpsen EuronextHead Of Corporate Brand Strategy CommunicationsCommittee For Orphan Medicinal ProductsCommittee For Medicinal Products HumanEuropean Society For Pediatric Gastroenterology HepatologyHead Of ResearchDevelopment For IpsenGlobal Corporate CommunicationsCommittee For Medicinal Products Human UseEuropean Medicines AgencyAlbireo Pharma IncMedicinal ProductsHuman UseOrphan Medicinal ProductsMarketing Authorisation ApplicationExecutive Vice President
Investegate | Company Announcement - Vimarsana News

Investegate | Company Announcement

Published: October 23, 2023

Investegate announcements from Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome

Source: investegate.co.uk
Related Topics:
France GeneralUnited KingdomUnited StatesAsia PacificIpsen EuronextChristelle HuguetJennifer MooreAmy WolfIoana PiscociuNicolas BoglerEuropean Medicines AgencyAlbireo Pharma IncEuropean Society For Pediatric Gastroenterology HepatologyCommittee For Medicinal Products HumanDevelopment For IpsenHead Of ResearchCommittee For Orphan Medicinal ProductsGlobal Corporate CommunicationsCommittee For Medicinal Products Human UseHead Of Corporate Brand Strategy CommunicationsAuthorisation ApplicationMedicinal ProductsHuman UseOrphan Medicinal ProductsMarketing Authorisation Application
Correction: Ipsen provides update on E.U. Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome - Vimarsana News

Correction: Ipsen provides update on E.U. Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome

Published: July 21, 2023

Positive opinion from Committee for Medicinal Products for Human Use based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome Negative opinion from Committee for Orphan Medicinal...

Source: marketscreener.com
Related Topics:
France GeneralUnited StatesUnited KingdomJennifer MooreIpsen EuronextNicolas BoglerIoana PiscociuHoward MayerAmy WolfAsia PacificDevelopment For IpsenCommittee For Medicinal Products Human UseHead Of Corporate Brand Strategy CommunicationsGlobal Corporate CommunicationsEuropean Medicines AgencyHead Of ResearchEuropean CommissionCommittee For Orphan Medicinal ProductsAlbireo Pharma IncEuropean Society For Pediatric Gastroenterology HepatologyMedicinal ProductsHuman UseBylvay PhaseOrphan Medicinal ProductsExecutive Vice President
Ipsen provides update on E.U. Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome - Vimarsana News

Ipsen provides update on E.U. Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome

Published: July 21, 2023

Positive opinion from Committee for Medicinal Products for Human Use based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome Negative opinion from Committee for Orphan Medicinal...

Source: marketscreener.com
Related Topics:
United KingdomFrance GeneralUnited StatesIpsen EuronextHoward MayerAsia PacificIoana PiscociuNicolas BoglerAmy WolfJennifer MooreHead Of Corporate Brand Strategy CommunicationsEuropean Society For Pediatric Gastroenterology HepatologyHead Of ResearchCommittee For Medicinal Products Human UseDevelopment For IpsenAlbireo Pharma IncEuropean CommissionGlobal Corporate CommunicationsCommittee For Orphan Medicinal ProductsEuropean Medicines AgencyMedicinal ProductsHuman UseBylvay PhaseOrphan Medicinal ProductsExecutive Vice President
U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome - Vimarsana News

U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome

Published: June 13, 2023

Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial... | June 13, 2023

Source: marketscreener.com
Related Topics:
France GeneralUnited StatesUnited KingdomRoberta SmithHoward MayerAnna GibbinsAmy WolfNadia OvchinskyAsia PacificIpsen EuronextNicolas BoglerIoana PiscociuFeldmanag NeoreviewsGlobal Head Of Franchise CommunicationsDrug AdministrationHuman ServicesUs Department Of HealthEuropean Medicines AgencyAmerican Association For Study Of Liver DiseasesDevelopment For IpsenHead Of Corporate Brand Strategy CommunicationsDivision Of GastroenterologyAlagille Syndrome AllianceHead Of ResearchCommittee For Medicinal Products Human