Tag Archives: CKD

GlaxoSmithKline: US FDA regulatory submission acceptance of New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor

(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the third major regulatory milestone for its daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of … Read the full press release

GlaxoSmithKline: Die Europäische Arzneimittel-Agentur (EMA) validierte den Antrag auf Marktzulassung (MAA) für Daprodustat, einen oralen Hypoxie-induzierbaren Faktor-Prolylhydroxylase-Hemmer zur Behandlung von Patienten mit Anämie bei chronischer Nierenerkrankung

Zulassungsantrag für die Behandlung von Anämie bei chronischer Nierenerkrankung basierend auf dem klinischen Phase-III-Studienprogramm ASCEND, bestehend aus fünf Studien, die alle ihre co-primären Wirksamkeits- und Sicherheitsendpunkte erreichten Die Zulassung der EMA-Anträge ist der erste große regulatorische Meilenstein für Daprodustat seit … Read the full press release

GlaxoSmithKline: European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat patients with anaemia of chronic kidney disease

Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release

AstraZeneca will use BenevolentAI’s advanced AI to dive into its disease area expertise and massive datasets to gain insights into the complex disease biology

AstraZeneca / BenevolentAI artificial intelligence collaboration will accelerate drug discovery Potential new drugs discovery in the area of chronic kidney disease and idiopathic pulmonary fibrosis (PRESS RELEASE) CAMBRIDGE / LONDON, 30-Apr-2019 — /EuropaWire/ — New partnership, announced today, by AstraZeneca … Read the full press release