The proton pump inhibitor's licensee responds to the agency's January complete response letter that detailed concerns about making Zegerid available OTC, according to drug originator Santarus June 9. Zegerid (omeprazole 20 mg/sodium bicarbonate) would likely face an increasingly crowded OTC PPI market, since FDA approved Novartis'/Takeda Pharmaceuticals' yet-to-launch Prevacid 24HR (lansoprazole 15 mg) in May (1"The Tan Sheet" May 18, 2009, p. 3)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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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.
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 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.