Teva’s At-Risk Launch Of Pulmicort Generics May Cost It Exclusivity
Teva's exclusivity clock may already be ticking following the short-lived launch of a generic version of AstraZeneca's Pulmicort. Generic sales for the product are now suspended by court order with a hearing on the preliminary injunction scheduled for Nov. 25
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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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The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.