Genzyme will exchange shares of Genzyme Biosurgery stock and Genzyme Molecular Oncology stock for shares of Genzyme General stock on June 30. "We do not expect to make any major changes within our business or research programs at this time," CEO Henri Termeer says. Termeer was asked about the company's capital structure in light of concerns about tracking stocks and corporate accounting during an April 16 earnings call (1"The Pink Sheet" April 28, In Brief)...
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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.