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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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  • Researchers find new mutation in the leptin gene June 21, 2019
    The global obesity epidemic is so far-reaching it now has an overarching name: globesity. Texas Biomed Staff Scientist Raul Bastarrachea, M.D., is part of a team that discovered a new mutation in the gene that regulates the key hormone suppressing hunger called leptin. This new mutation could help researchers understand why people develop excess of […]
  • Rare recessive mutations pry open new windows on autism June 21, 2019
    Over the past decade, autism spectrum disorder has been linked to mutations in a variety of genes, explaining up to 30 percent of all cases to date. Most of these variants are de novo mutations, which are not inherited, affect just one copy of a gene, and are relatively easy to find. The lab of […]
  • Researchers discover new genetic link to premenopausal breast cancer June 20, 2019
    University of Alberta researchers have added a new genetic marker to the breast cancer map, helping to expand the list of genetic mutations clinicians can watch for in cancer screenings.
  • How do birth defects affect childhood cancer risk? June 20, 2019
    (HealthDay)—Children with birth defects may be at increased risk for childhood cancer, a new study finds.
  • God doesn't play dice, does cancer? June 20, 2019
    The saying "God doesn't play dice" is meant to suggest that nothing happens by chance. On the other hand, cancer seems like the ultimate happenstance: Don't we all have a 43-year-old, vegan, triathlete friend fighting cancer? Does this mean that cancer plays dice? According to the traditional model of how cancer develops, yes: Every time […]
  • Oral steroids put patients with inflammatory disease at high risk of infection June 24, 2019
    Oral steroid use in patients with the inflammatory diseases polymyalgia rheumatica and/or giant cell arteritis significantly increased the risk of infection, and the risk increased with higher doses, found a study in CMAJ (Canadian Medical Association Journal).
  • Study finds micronutrient deficiencies common at time of celiac disease diagnosis June 24, 2019
    Micronutrient deficiencies, including vitamins B12 and D, as well as folate, iron, zinc and copper, are common in adults at the time of diagnosis with celiac disease. These deficiencies should be addressed at that time, according to a study by Mayo Clinic researchers.
  • Survivors of childhood brain tumors experience lasting cognitive and socioeconomic burdens June 24, 2019
    Survivors of childhood brain tumors who received radiotherapy and were very young at the time of diagnosis may experience cognitive and socioeconomic burdens decades after treatment, according to a study published early online in CANCER, a peer-reviewed journal of the American Cancer Society. Interventions such as cognitive therapies and educational and occupational services may be […]
  • New reports provide guidance for obesity care June 24, 2019
    Advocates for obesity prevention and treatment have designed two new resources for medical educators, healthcare providers and community programs that will enhance the level of care for patients, according to two new studies published online today in Obesity, the flagship journal of The Obesity Society. The resources include the first set of competencies for how […]
  • Suicide, accidents, and hepatitis: The leading causes of death for Veterans in their first year of PTSD treatment June 24, 2019
    According to a new study in the American Journal of Preventive Medicine, published by Elsevier, United States Veterans seeking treatment for posttraumatic stress disorder (PTSD) are at increased risk of death compared with the general population. Veterans with PTSD are twice as likely to die from suicide, accidental injury, and viral hepatitis than the general […]
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