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AstraZeneca LP

Latest From AstraZeneca LP

Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program

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.

Medicare Pricing Debate

FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

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.

Advertising, Marketing & Sales Real-World Evidence

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

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.

BioPharmaceutical Market Access

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.

Legal Issues FDA
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