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4. Dépistage, diagnostic et pronostic
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4.1 Dép., diag. & prono. - Prostate
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4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
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Why FDA Should Oversee Laboratory Developed Tests [FDA]
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Today
FDA is issuing a report that illustrates the real and potential harms
to patients and to public health from certain laboratory developed tests
(LDTs) – tests that are designed, manufactured and used in a single
laboratory.
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5. Traitements
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5.10 Traitements - Essais
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5.2 Pharma
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5.2.3 Pharma - économie
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Clovis Blowup Conjures Bad Biotech Memories of ImClone Darkness [TheStreet]
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For
those too young to remember, ImClone, in 2001, was cruising towards FDA
approval of its targeted colon cancer drug Erbitux. Investors loved the
stock. But the feel-good story ended abruptly in late December of that
year when the U.S. Food and Drug Administration rejected Erbitux, citing
ImClone's failure to provide adequate documentation of the drug's
response rate in a pivotal clinical trial.
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5.3.4 Traitements - AMM (FDA, EMA)
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FDA approves J&J drug for advanced multiple myeloma [Reuters]
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In
one 106-patient study, tumors shrank or were no longer detectable in 29
percent of patients taking Darzalex, and the benefit lasted for an
average of 7.4 months. In a second trial, involving 42 patients, 36
percent of patients taking the J&J/Genmab drug saw a partial or
complete reduction in tumors.
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5.4 Traitements - Economie
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5.7.1 SABCS-communiqués
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6.10 Politiques
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6.7 DMP, Big Data & applis
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