Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial is being led by Lanhzou Biotechnique Development
Pfizer is likely to show GSK significant competition
UTD2 is the world's first oral epothilone microtubule inhibitor
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
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.
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
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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
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