Blog Archives

Bevacizumab [Avastin] in den USA zur Behandlung von Brustkrebs zurückgezogen

24. Dezember 2010 – Swissmedic teilte per 17. Dezember 2010 mit, dass sie durch die amerikanische Heilmittelbehörde FDA  darüber informiert wurde,  dass  die Zulassung von Bevacizumab [Avastin] zur Behandlung von Brustkrebs in den USA zurückgezogen werden soll (siehe dazu auch die Blog-Post hier).

Die Zulassung für dieses Anwendungsgebiet wurde in den USA 2008 in einem beschleunigten Verfahren erteilt,

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Bufexamac-haltige Arzneimittel zur topischen Anwendung: Widerruf der Zulassungen in der EU wegen ungünstigen Nutzen-Risiko-Verhältnisses

27. April 2010 – Die Bewertung des BfArM, dass Bufexamac-haltige Arzneimittel zur topischen Anwendung in den zugelassenen Indikationen ein insgesamt ungünstiges Nutzen-Risiko-Verhältnis aufweisen und die Zulassungen deshalb zu widerrufen sind, wurde durch den Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittelagentur  (EMEA) auf seiner April-Sitzung bestätigt.

Bufexamac-haltige Arzneimittel wurden in der Dermatologie und Proktologie zur Behandlung von chronischen Ekzemen und Dermatosen sowie bei Entzündungen in der Analregion angewendet.

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Sistierung der Schweizer Marktzulassung von Sibutramin [Reductil]

31. März 2010 – Wir lernen heute aus einer Mitteillung des Schweizerischen Heilmittelinstitutes (Swissmedic), dass die Abbott AG, in Abstimmung mit Swissmedic. sie über die sofortige Sistierung der Marktzulassung für Sibutramin [Reductil] in der Schweiz informiert. Ab sofort darf Sibutramin [Reductil] weder durch Abbott vertrieben noch durch Apotheker oder Ärzte an Patienten abgegeben werden.

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Efalizumab [Raptiva] Zulassung sistiert

Die Zulassung von Efalizumab [Raptiva] wird in der Schweiz zum 1. Mai 2009 sistiert. Es sollen bis auf weiteres keine neuen Patienten mehr auf Raptiva eingestellt werden.

Raptiva ist ein immunsuppressiv wirksamer, humanisierter monoklonaler Antikörper, der 2004 in der Schweiz zur Behandlung von erwachsenen Patienten mit mittelschwerer bis schwerer Psoriasis vom Plaque-Typ zugelassen wurde.

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  • Genetic tests may differ in their interpretation of certain variants July 1, 2020
    (HealthDay)—Different genetic test interpretations have been identified for genetic variants, and some of these can impact patient management, according to a research letter published online June 30 in the Annals of Internal Medicine.
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    New research is helping unlock the mystery of how the brain folds as a baby develops in the womb—a process critical to healthy brain function.
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    Melbourne researchers have developed a fast, new test for infections and infectious diseases that could transform Australia's ability to provide targeted clinical care and respond to pandemics and biosecurity threats.
  • Next-generation sequencing to provide precision medicine for rare metabolic disorders June 30, 2020
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  • New genomic atlas of the developing human brain June 30, 2020
    For the nascent brain of a human embryo to develop into the complex organ that controls human consciousness, a finely tuned sequence of genetic events has to take place; hundreds of genes are activated and deactivated in a precise symphony. Mutations in these genes disrupt the molecular instruments of the symphony and, if they occur […]
  • Understanding molecular mechanisms of air pollution's impact on ILD critical July 1, 2020
    More research must be done to investigate the role of air pollution on the epigenome in patients with interstitial lung diseases (ILDs), in order to develop strategies that minimize the effects of these pollutants, according to a new article published online in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine.
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    Researchers have developed a computational model that helps users understand how changes in the nanostructure of materials affect their conductivity - with the goal of informing the development of new energy storage devices for a wide range of electronics.
  • Traffic data show drastic changes in Floridians' behavior at onset of the pandemic July 1, 2020
    Using same-day traffic volumes for March 2019 and March 2020 across Florida, researchers examined the relationship of key governmental requests for public isolation and travel limitations. Results show the drastic changes in human behavior during the onset of the pandemic. Traffic volumes by March 22, 2020, dropped by 47.5% compared to that same point in […]
  • A shake-up in cell culturing: Flame sterilization may affect the culture July 1, 2020
    Researchers from the University of Tsukuba have found that flame-sterilizing shake-flasks, to avoid introducing microbial contaminants, considerably increases the carbon dioxide concentration in the flasks. This enhanced carbon dioxide concentration affects the growth of some microbial species, which may affect the quantity of vaccines or other valuable substances produced by the microbes.
  • Lifetime discrimination may increase risk of hypertension among African Americans July 1, 2020
    A study of African Americans in Mississippi shows an association between experiencing discrimination over a lifetime and developing hypertension (also referred to as high blood pressure).African Americans who reported medium and high levels of lifetime discrimination, compared to those who reported low lifetime discrimination, had a higher risk for hypertension.