CMS Delays Inclusion Of Oral-Only ESRD Drugs In Final Bundled Payment Rule For Medicare
Inclusion of oral-only drugs in bundled payment will be delayed until 2014, allowing CMS to address pricing and data issues, but the decision does not alter the agency's interpretation that oral-only drugs should be a part of the bundle.
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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.’
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Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.