GSK Commit Lozenge Phase IV Studies On Contraindications, AEs Planned

GlaxoSmithKline's Phase IV obligations for its Commit nicotine polacrilex lozenge include a study of consumers who are contraindicated for use of the OTC smoking cessation drug due to underlying health conditions, FDA's Oct. 31 approval letter states

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
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China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.