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ANSM et le thérapie génique: accès précoce aux premiers médicaments innovants “CAR T-Cells”

27 juillet 2018 –  Cette point d’information vient de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) concernant l’accès précoce aux premiers médicaments innovants “CAR T-Cells” dans le traitement de certains cancers hématologiques.

En juin 2018, l’Agence européenne des médicaments (EMA) a rendu un avis positif pour l’autorisation de mise sur le marché des deux premiers médicaments de thérapie génique Kymriah et Yescarta appelés “CAR T-Cells”,

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Enfin: Le valproate est interdit pendant la grossesse

17 juin 2018 – Venant de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM), on apprend que le valproate est finalement interdit pendant la grossesse et ne doit plus être prescrit aux filles, adolescentes et femmes en âge de procréer (sauf circonstances exceptionnelles).

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Décision favorable du CHMP pour le Darvadstrocel (Alofisel) dans le traitement des fistules périanales

18 décembre 2017 – Le Comité des Médicaments à Usage Humain (Committee for Medicinal Products for Human Use (CHMP)) de l’Agence Européenne des Médicaments (European Medicines Agency (EMA)), ainsi que le Comité des Thérapies Avancées (Committee for Advanced Therapies (CAT)),

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Finalisation de l’arbitrage concernant le médicament TYSABRI (natalizumab) sur le risque de leucoencéphalopathie multifocale progressive (LEMP)

23 Février 2016 – Ce message vient de l’ANSM et se reflète dans leur formulation:

Lors de sa réunion mensuelle, du 8 au 11 février 2016 à Londres, le Comité pour l’Evaluation des Risques en matière de Pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) a finalisé la revue des données concernant le risque de leucoencéphalopathie multifocale progressive (LEMP) associé à TYSABRI (natalizumab).

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Le PRAC poursuit la revue des données sur le risque de LEMP associé à Tysabri (natalizumab)

07 Janvier 2016 – Ce message vient de l’ANSM et se reflète dans leur formulation:

Lors de sa réunion mensuelle, qui s’est tenue du 30 novembre au 3 décembre 2015 à Londres, le Comité pour l’Evaluation des Risques en matière de Pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) a poursuivi la revue des données concernant le risque de leucoencéphalopathie multifocale progressive (LEMP) associé à Tysabri (natalizumab).

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  • Multi-omics approach offers new insights into peanut allergy severity décembre 13, 2019
    Researchers at the Icahn School of Medicine at Mount Sinai have identified novel genes associated with the severity of peanut allergy, as well as ways in which these genes interact with other genes during allergic reactions.
  • DNA tests make fun holiday gifts, but beware of the hype décembre 13, 2019
    You've likely heard about direct-to-consumer DNA testing kits. In the past few years, at-home genetic testing has been featured in the lyrics of chart-topping songs, and has helped police solve decades-old cold cases, including identifying the Golden State Killer in California.
  • Research reveals how muscles talk to the brain to regulate feeding behavior décembre 13, 2019
    The brain determines when it is time to feed—but how does it know? Findings from St. Jude Children's Research Hospital provide new understanding of how the brain orchestrates this process. Skeletal muscle, like other tissues, communicates with the brain to convey information about nutritional status. The researchers showed that manipulating this mechanism influences food seeking […]
  • New drugs more likely to be approved if backed up by genetics décembre 12, 2019
    A new drug candidate is more likely to be approved for use if it targets a gene known to be linked to the disease; a finding that can help pharmaceutical companies to focus their drug development efforts. Emily King and colleagues from AbbVie report these findings in a new study published 12th December in PLOS […]
  • Largest study of its kind reveals that many psychiatric disorders arise from common genes décembre 12, 2019
    Many distinct psychiatric diseases share a common genetic structure, according to new research by scientists at Massachusetts General Hospital (MGH) and the Psychiatric Genomics Consortium, an international team of investigators. Psychiatric disorders affect more than 25 percent of the population in a given year. In the largest-ever study of its kind, published in the journal […]
  • Emergency department study reveals patterns of patients at increased risk for suicide décembre 13, 2019
    A new NIMH-funded study has found that people who presented to California emergency departments with deliberate self-harm had a suicide rate in the year after their visit 56.8 times higher than demographically similar Californians. People who presented with suicidal ideation had suicide rates 31.4 times higher than demographically similar Californians in the year after discharge. […]
  • Patient-reported outcomes predict aromatase inhibitor adherence décembre 13, 2019
    If you want to predict which breast cancer patients will most likely stop taking aromatase inhibitors, check out their own responses to the health questions patients commonly answer in cancer clinical trials, according to research findings to be presented Friday, Dec. 13, 2019 at the San Antonio Breast Cancer Symposium.
  • Saliva test shows promise for earlier and easier detection of mouth and throat cancer décembre 13, 2019
    Unfortunately, cancers that occur in the back of the mouth and upper throat are often not diagnosed until they become advanced. A report in The Journal of Molecular Diagnostics describes the use of acoustofluidics, a new non-invasive method that analyzes saliva for the presence of human papilloma virus (HPV)-16, the pathogenic strain associated with oropharyngeal […]
  • Barrels of ancient Antarctic air aim to track history of rare gas décembre 13, 2019
    An Antarctic field campaign last winter led by the US and Australia has successfully extracted some of the largest samples of air dating from the 1870s until today. Researchers will use the samples to look for changes in the molecules that scrub the atmosphere of methane and other gases.
  • Perinatal exposure to flame retardant alters epigenome, predisposing metabolic disease décembre 13, 2019
    A UMass Amherst study showed that environmentally relevant exposure to polybrominated diphenyl ether (PBDE), a brominated flame retardant, through the umbilical cord and breast milk permanently changed liver metabolism in rats.
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