Positive Feelings About Negative Controls: US FDA Explores Another Tool For The Real-World Evidence Toolbox
CDC precedents and PDUFA VII commitments could help advance the robustness of observational studies based on real-world data.
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Everybody Stumbles: US FDA Complete Response Letters To Big Pharma
Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval
Pfizer’s lineup of novel agents under review stands at seven, while no other big pharma has more than two novel candidates; Sanofi is tops in recent approvals since 2021, with seven novel agents cleared, but has no pending NMEs.