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1. Biologie
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4.12 Biopsies liquides
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4.9 Dép., diag. & prono. - Sein
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5.12 Immunothérapies
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5.12.10 Immunothérapies - Fusions et acquisitions
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5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
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5.12.5 Immunothérapies - Pharma
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5.2.1 Pharma - Partenariats
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Janssen taps South Korea’s Yuhan for Tagrisso rival [FierceBiotech]
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Lazertinib
is however a long way behind Tagrisso (osimertinib), AstraZeneca’s
fast-growing rival in the third-generation category, which has already
become established as a second-line treatment for EGFR-mutated NSCLC and
this year has claimed its first approvals as a first-line option.
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5.3 Traitements - FDA, EMA, NICE...
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Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance [RAPS]
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The
draft says meta-analyses are most useful in detecting and quantifying
an increased risk over the background rate of a safety event. And with
aggregating data, a sponsor may be able to provide a higher statistical
power and more robust estimate than may be possible with an individual
study.
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5.3.4 Traitements - AMM (FDA, EMA,...)
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6.1 Observation
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Linking a lie-in to breast cancer misreads the science [The Guardian]
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Encouraging
women to adjust their sleeping patterns – as some headlines trumpeted –
is misleading. First, the study didn’t look at women’s actual sleeping
patterns. Although participants were asked if they considered themselves
to be “morning” or “evening” people, their actual behaviour, such as
when they got up and when they went to bed, wasn’t recorded.
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6.7 DMP, Big Data & applis
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6.7.2 Applis
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FDA’s MyStudies Application (App) [FDA]
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The
FDA MyStudies App is designed to facilitate the input of real world
data directly by patients which can be linked to electronic health data
supporting traditional clinical trials, pragmatic trials, observational
studies and registries.
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