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Latest From AstraZeneca LP
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.
Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over All FDA Approvals, Drug Industry Tells Supreme Court
As Supreme Court term begins, PhRMA and host of pharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court also will consider lawsuit challenging deference to federal rulemaking and may consider another that would increase corporate liability under Anti-Terrorism Act.
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