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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 launch and availability for eligible patients ASSERT clinical study demonstrated efficacy of ...
Seven abstracts to be presented demonstrating treatment effects of Bylvay ® in two cholestatic liver diseases, progressive familial intrahepatic cholestasis and Alagille syndrome Data to be presented from a qualitative trial on patient validation of pruritus (itch) and fatigue assess...
Palovarotene is the first medicine to be submitted for regulatory approval for fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease with an estimated prevalence of 1.36 per million individuals and around 900 people diagnosed worldwide. 1,2 FOP continuously and permanently ca...
Six abstracts to be presented demonstrating efficacy and tolerability of investigational Bylvay in select cholestatic liver diseases New data emphasizes the consistent benefit of Bylvay as an investigational drug in Alagille syndrome and an approved medicine in PFIC, with evidence of rapid, s...
2023-05-11 16:04:46 ET Summary Results from the phase 3 ELATIVE study, using elafibranor to treat patients with primary biliary cholangitis, are expected to be released before end of Q2 of 2023. The primary biliary cholangitis market is expected to reach $1.7 billion by 2029. ...
Ipsen appoints Sandra Silvestri as EVP, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs PARIS, FRANCE , 24 April 2023 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, announced today...
Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP PDUFA date has been set for 16 August 2023 following the New Drug Application resubmission containing additional information on palovarotene clin...
2023-03-09 09:05:52 ET Exelixis ( NASDAQ: EXEL ) shares ticked higher in the pre-market trading Thursday after Wells Fargo launched its coverage on the cancer drugmaker with an Overweight recommendation and a $23 per share target citing the sales potential of its lead rev...
Ipsen completes acquisition of Albireo , expanding the scope of its R are D isease portfolio Bringing medicines to patients with rare liver disease, a growth opportunity for Ipsen Lead asset Bylvay® (odevixibat) is the first approved tr...
Ipsen e xtends e xpiration d ate of t ender o ffer for Albireo Pharma , Inc. to 1 March 202 3 Extension a llows for the satisfaction of the HSR Act related condition as o utlined ...
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Decision adds to existing collaboration agreement with Exelixis, permitting Ipsen to seek potential marketing authorizations for Cabometyx ® (cabozantinib) in advanced pancreatic and extra pancreatic neuroendocrine tumors outside of the U.S. and Japan Agreemen...
Iqirvo ® (elafibranor) 80 mg tablets is the first new medicine approved in nearly a decade for the treatment of the rare liver disease called primary biliary cholangitis Approval based on positive Phase III ELATIVE trial data Primary biliary cholan...
Using Marengo’s TriSTAR platform, Ipsen and Marengo teams expand their ongoing oncology research to include up to two additional assets in new early development collaboration Research will focus on using Marengo’s TriSTAR platform to reinvigorate and mobilize selective V...