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1. Biologie
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2. Etiologie
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FDA widening probe into heart drugs linked to cancer risk [STAT]
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The
agency estimated that if 8,000 people took the highest valsartan dose
of 320 mg in a pill containing NDMA daily for four years — which is the
amount of time the FDA believes the affected pill had been on the U.S.
market — there may be one additional case of cancer over their lifetimes
beyond the average cancer rate among Americans.
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4.12 Biopsies liquides
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5.1 Traitements - Pré-clinique
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5.12 Immunothérapies
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5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
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RootPath Raises $7M to Bring Cancer Cell Therapy to Solid Tumors [Xconomy]
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RootPath’s
approach is similar to CAR-T up to a point, Chen says. T cells are
collected, and they are ultimately infused back into the patient. But
Chen says RootPath has developed technologies that enable it to analyze
and sequence individual T cells, which helps identify the ones that are
best suited to recognizing and fighting the tumor.
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5.12.3 Immunothérapies-combinaisons
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5.12.8 Immunothérapies - Economie
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Engineered cell therapy given initial ‘no’ for NHS in England [Cancer Research UK]
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Meindert
Boysen, director of the centre for health technology evaluation at
NICE, said: “We have been working with the companies involved, and with
NHS England, with the aim of ensuring that patients in England are among
the first to have access to these new treatments in Europe.” "Although
promising, there is still much more we need to know about CAR T," he
added.
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5.2 Pharma
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5.3 Traitements - FDA, EMA, NICE...
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FDA starts pilot to help sponsors use novel trial designs [FierceBiotech]
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Officials
at the FDA committed to help advance the use of complex adaptive,
Bayesian and otherwise novel clinical trial designs as part of the
latest PDUFA agreement. These designs pose new challenges for sponsors
such as the need to use simulations to determine trial operating
characteristics, and therefore additional regulatory input is beneficial
to ensure they meet the FDA’s expectations.
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Towards improving the availability of medicines in the EU [EMA]
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Improving
the availability of human and veterinary medicines authorised in the EU
is a key priority of the EU Network. The work programme lists actions
for regulators and industry alike to ensure the availability of
medicines for the benefit of patients in the EU.
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6.1 Observation
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6.10 Politiques
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6.6 Publications
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6.9 Controverses
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