NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers
Part of the Cancer Moonshot program, the five-year, $215 million research collaboration will be mostly funded by NIH with money from the 21st Century Cures Act.
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US FDA's Top Tips For Tumor Agnostic Drug Development
'Although sponsors have conventionally focused on the development of a drug, the strategy of pursuing site-agnostic indications must focus on both drug and biomarker development,' FDA's Richard Pazdur and colleagues write in the New England Journal of Medicine.
Biomarker-Led Claim Is Small Step For Merck's Keytruda, Giant Leap For Cancer Indications
Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US FDA has granted an indication that does not specify the location of the tumor – a change precision medicine researchers have been eager to make.
Clinical Trial Challenges: FDA Wants More Prospective Studies, Validated Biomarkers
NIH Director Collins and FDA Commissioner Califf discuss difficulties with ‘big science,’ ‘small crappy trials,’ and ‘data landlords.’