A key provision of the Medicare Modernization Act's forfeiture provision for ANDA filers' 180-day exclusivity could be moot if courts continue to refuse to hear petitions by generic companies for declaratory judgments
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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 list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.
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.
