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  3. Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

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Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14).

More On These Topics From The Pink Sheet

Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval

BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push

EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation

Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes
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Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes
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