The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial is being led by Lanhzou Biotechnique Development
The new lab will enable the Group to accelerate its efforts in this area, building new competencies and capabilities, as well as strengthening Solvay’s ability to develop breakthroughs in biodegradable-by-design solutions.
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
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