Pharma firms will see few policy changes following the publication of FDA's final regulations on expanded access to investigational medicine, but the revisions could nevertheless mean more patients and doctors will come knocking on their doors asking for experimental drugs
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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.’
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.
The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.
