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Latest From AstraZeneca LP
Pharma Dubs EU HTA Proposal ‘Unworkable,’ But Patient Groups Support The Plan
Pharmaceutical companies, NGOs, and patient organizations were among the 129 respondents to the European Commission’s consultation on its draft implementing act for joint clinical assessments – but opinions on the proposal were divided.
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.
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.
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.
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