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Latest From Approvals
Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.
Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.
Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.
GC Pharma/Biocon are set to adopt a low price strategy for their biosimilar insulin glargine, which has just received regulatory approval in South Korea, to better compete with rival products.
A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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