Legal Briefs: Concordia/Par And FTC; Amgen Off-Label Compendium Settlement
FTC objected to atypical Concordia deal with Par not to launch an authorized generic in return for share of profits on Par’s generic; Amgen settlement with 49 states restricts interactions with compendium.
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Amgen pled guilty to off-label promotion of Aranesp, and settled civil claims of kickbacks, false price reporting and off-label promotion of other drugs; Sanofi settles claims it provided kickbacks in the form of free Hyalgan samples.
Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.
Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.