(IN BRIEF) GSK has announced that momelotinib, a differentiated JAK inhibitor marketed as Ojjaara or Omjjara in approved indications, has received orphan drug designations from the US Food and Drug Administration and the European Medicines Agency for the treatment of … Read the full press release
Posted in Business, European Union, Government, Healthcare, Law, Pharma & Biotech, Science, Technology, United Kingdom
Tagged activin A receptor type I, ACVR1, anaemia, ATLAS trial, bone marrow failure, clinical trial, clonal myeloid disorder, EHA Congress, EMA, European Hematology Association Congress, European Medicines Agency, FDA, GSK, GSK Advances Momelotinib Development Programme With Orphan Drug Designations for VEXAS Syndrome, GSK’s Momelotinib Receives US and EU Orphan Drug Designations for Rare VEXAS Syndrome, haemato-inflammatory condition, haematologic features, haematologic malignancy, hepcidin, JAK inhibitor, JAK1, JAK2, Janus kinase 1, Janus kinase 2, life-threatening disease, lung involvement, macrocytic anaemia, momelotinib, Momelotinib Gains Regulatory Support in US and EU as GSK Targets High Unmet Need in VEXAS Syndrome, myelofibrosis, neutrophilic dermatosis, ODD, Ojjaara, Omjjara, orphan drug designation, phase II/III trial, rare disease, rare disorder treatment, regulatory submissions, relapsing chondritis, rheumatologic features, splenomegaly, thrombocytopenia, UBA1 gene mutation, US Food and Drug Administration, uveitis, Vacuoles E1 enzyme X-linked Autoinflammatory Somatic syndrome, vasculitis, VEXAS syndrome
(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, cancer research, EMA, EMA Grants Orphan Drug Designation to GSK’s B7-H3 Antibody-Drug Conjugate for Pulmonary Neuroendocrine Carcinoma, FDA, GSK, GSK Strengthens Oncology Pipeline With EMA Orphan Drug Status for GSK’227 in Small-Cell Lung Cancer, GSK5764227, GSK’227, immuno-oncology, lung cancer, NEC, ODD, oncology, oncology pipeline, orphan drug designation, PRIME designation, pulmonary neuroendocrine carcinoma, relapsed or refractory, SCLC, Small cell lung cancer, solid tumours, targeted therapy
(ACTUALITÉ EN BREF) DNV, un expert indépendant en énergie et fournisseur d’assurance, a signé un protocole d’accord (MoU) avec l’Egyptian General Petroleum Corporation (EGPC) pour soutenir leurs efforts dans la définition d’objectifs fondés sur la science pour leurs objectifs nets … Read the full press release
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