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Clinical / R&D

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Latest From Research & Development

Was PD-L1 Test To Blame For Failure Of Bristol's Opdivo In '026 Trial?

NEJM editorial suggests that differences in PD-L1 testing may explain why Bristol's Opdivo failed in first-line lung cancer trial whereas Merck's Keytruda succeeded, but some analysts aren't so sure.

ImmunoOncology Clinical Trials

US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb

Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.

Drug Approval Standards Rare Diseases

Orphan Biosimilars: Developers See Big Prospects In Small Markets; Soliris Is One Target

Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US – some developers are starting to 'think small' with biosimilars for rare disease markets. Alexion’s Soliris is a case in point.

Biosimilars Rare Diseases

Biomarker Qualification 2.0: Cures Act, User Fees Will Enhance FDA Pathway

US agency will be more 'proactive' in engaging with outside groups interested in using the biomarker qualification process using the new resources and directives of the 21st Century Cures Act and the pending Prescription Drug User Fee Act reauthorization.

Research & Development Regulation

EU Non-Human Primate Opinion Is A “Tremendous Missed Opportunity”

An opinion from a European Commission committee on using non-human primates in pharmaceutical research is being criticized as a missed opportunity that wastes time in developing new models of biomedical research.

BioPharmaceutical Regulation

Work To Replace, Reduce And Refine But Use Of Non-Human Primates In Research Still Necessary, Says EU Panel

Non-human primates will have to continue to be used in biomedical research for the foreseeable future, according to the European Commission’s Scientific Committee on Health Environmental and Emerging Risks. A ban would stall scientific progress but work should continue under the replacing, reducing and refining approach, the panel says.

BioPharmaceutical Regulation
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