Legal & IP
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Latest From Legal Issues
FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.
Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.
First biosimilar of Epogen/Procrit might launch this year, but timing of market entry will depend on many factors, including ongoing patent litigation with Amgen in Delaware federal court.
There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.
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