In-licensing and development of so-called "bio-betters" will play critical roles in Pfizer's move, announced June 14, into the rare diseases space. The Rare Diseases Research Unit, to be overseen by Jose Carlos Gutierrez-Ramos, senior VP, Biotherapeutics Research and Development, will be part of Pfizer's worldwide R&D unit devoted to discovering novel medicines for orphan diseases, those affecting fewer than 200,000 patients. Initially it will target hemophilia and muscular dystrophy, both caused by genetic mutations
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
