Over-the-counter drug makers can advance the EU centralized switch process by keeping the applications coming so that health authorities can "learn by doing," says Patrick Le Courtois, head of the human medicines development and evaluation unit at the European Medicines Agency
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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.’
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
