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Aeglea s Pegzilarginase Hits Primary, but Misses Secondary, Endpoints in Phase 3 Study in Patients with Arginase 1 Deficiency

Aeglea s Pegzilarginase Hits Primary, but Misses Secondary, Endpoints in Phase 3 Study in Patients with Arginase 1 Deficiency
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New yorkUnited statesGeorge diazAeglea biotherapeuticsAnthony quinnEuropean medicines agencyDrug administrationInherited metabolic disordersMount sinai hospitalMinute walk testLong term extensionLabel extensionRare pediatric diseaseBreakthrough therapyFast trackOrphan drug

X4 Pharmaceuticals to Have Strong Presence at ASH 2021 with Seven Accepted Abstracts

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

United statesPaula raganRouco molinaMary dibiaseDevelopment expensesExchange commissionAmerican society of hematologyLifesci communicationsPharmaceuticals incOral administration of mavorixaforInvestor dayAmerican societyAnnual meetingChief executive officerClinical response dataLong term extension

Bristol Myers Squibb Presents New Clinical and Real-World Data on Mavacamten and Obstructive Hypertrophic Cardiomyopathy at Upcoming American College of Cardiology s 70th Annual Scientific Session

New analysis of EXPLORER-HCM trial assessing impact of mavacamten on patient’s health status to be presented as late-breaking oral presentation Interim results of EXPLORER long-term extension study of mavacamten safety and efficacy data in patients with obstructive hypertrophic cardiomyopathy also to be presented Bristol Myers Squibb today announced that data from multiple studies across the company’s clinical … New analysis of EXPLORER-HCM trial assessing impact of mavacamten on patient’s health status to be presented as late-breaking oral presentation Interim results of EXPLORER long-term extension study of mavacamten safety and efficacy data in patients with obstructive hypertrophic cardiomyopathy (oHCM)

United statesJay edelbergJohna spertusBristol myers squibbSusan francisSnehas jainFlorian raderAmerican college of cardiologyClinical researchi sessionExchange commissionCardiomyopathy development at bristol myers squibbClinical researchHealth status benefits of mavacamtenMyers squibbAmerican collegeAnnual scientific session

LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021

LEO Pharma LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021 Monday, April 26, 2021 1:00PM IST (7:30AM GMT) Ballerup, Denmark & Madison, N.J., United States: Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients 1 Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years 1 1 LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

United statesLinda mayerAndrew blauveltOregon medical research centerGlobal researchEuropean medicines agency onAmerican academy of dermatology virtual meeting experienceNational library of medicineCommittee for medicinal products human useGlobal product communicationsAmerican academyDermatology virtual meeting experienceInvestigator global assessmentEczema areaSeverity indexExecutive vice president

Redirecting to LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021

2.0 (2.4) Participants included 1,174 patients from ECZTEND at data cut-off.1 Observed outcomes for all patients enrolled 60 weeks prior to data cut-off (n=513) were analyzed at Week 56.1 At parent-trial baseline, ECZTEND baseline, and Week 56, median EASI score was 26.6, 4.7, and 1.8, respectively.1 At Week 56, IGA and EASI response rates were 49.7% (IGA 0/1), 95.1% (EASI-50), 82.8% (EASI-75), 61.0% (EASI-90), and 79.7% (EASI ≤7). An EASI score of ≤7 corresponds to mild atopic dermatitis.1 At the same 56-week data cut-off, measurements of itch and sleep disruptions due to itch were also reported.1 At Week 56, the mean worst weekly pruritus (i.e. itch) numeric rating scale (NRS) score was 3.3 (parent-trial baseline was 7.7) while the mean eczema-related weekly sleep NRS score was 2.0 (parent-trial baseline was 6.9).1

United statesAndrew blauveltOregon medical research centerAmerican academy of dermatology virtual meeting experienceGlobal researchNational library of medicineEuropean medicines agency onCommittee for medicinal products human useAmerican academyDermatology virtual meeting experienceInvestigator global assessmentEczema areaSeverity indexExecutive vice presidentMedicinal productsHuman use