To investigate on-target activity of ruxolitinib, we investigated tissue-based and transcriptional evidence of JAK–STAT signaling inhibition comparing metastatic biopsies obtained pre-treatment and prior to cycle 2. A total of 14 patients underwent study biopsy with nine patients having baseline biopsy ...
NMD Pharma Receives FDA IND Clearance to initiate a Phase 2b Clinical Trial of NMD670 in Generalized Myasthenia Gravis Patients in the US Aarhus, Denmark, 22 March 2024– NMD Pharma A/S, a clinical-stage biotech company dedicate...
台北2023年5月31日/美通社/ -- 康霈(6919-TW)旗下新藥CBL-514注射劑經美國食品藥物管理局(U.S. FDA)核准執行用於減少皮下脂肪(非手術局部減脂)之Phase 2b臨床試驗(CBL-0204 Phase2bStudy, NCT05736107),已開始進行受試者招募,預計將於2024年Q2完成相關試驗數據收集,惟實際時程將依執行進度調整。 康霈生技...
Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS). These data were presented as a late-brea...
US Food and Drug Administration https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence (2022). Stephens, P. et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. Nature 431, 525–526 (2004). Article CAS PubMed Google Scholar Wei, X.-W....
The company's Advanced ALN-TTRsc02 is a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. The company reached alignment with the FDA on a pivotal phase III study for ALN-TTRsc02 in patients with hATTR amyloidosis. ...
Data have been submitted to the FDA as part of its submission for Emergency Use Authorization, and findings from the EPIC-HR interim analysis have been submitted to a peer-reviewed journal for publication. In August 2021, Pfizer began the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition ...
(U.S. FDA), respectively. Announced by the National Health Commission onSeptember 20th2023,China’ssecond catalog of rare diseases contains achondroplasia (ACH) within 86 rare diseases of 17 medical specialties, including hematology, dermatology and pediatrics.[2]In recent...
Immune responses and clinical outcomes in STAND, a randomized phase 2 study evaluating optimal sequencing of sipuleucel-T (sip-T) and androgen deprivation therapy (ADT) in biochemically-recurrent prostate cancer (BRPC) after local therap... 143 Background: Sip-T, an FDA-approved autologous immunot...
The safety and efficacy of zilebesiran have not been established or evaluated by the FDA, EMA or any other health authority. Zilebesiran is being co-developed and co-commercialized by Alnylam and Roche. About Hypertension Uncontrolled hypertension is the chronic elevation of blood pressure (BP...