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کانادا ژن‌درمانی فایزر را برای هموفیلی B تائید کرد @اخبار دارو و سلامت

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Create: 2024-01-05 Update: 2024-05-23 08:27:22

کانادا ژن‌درمانی فایزر را برای هموفیلی B تائید کرد

🔹فانا: فایزر روز چهارشنبه اعلام کرد که رگولاتور سلامت کانادا سریعتر از سازمان غذا و دارو آمریکا (FDA)، ژن‌درمانی این شرکت را برای درمان یک اختلال خونریزی‌دهنده ارثی نادر به نام هموفیلی B تائید کرد

🔹این تائیدیه براساس نتایج مطالعات فاز نهایی است که نشان داد یک دوز از این درمان با نام تجاری Beqvez، بهتر از استاندارد مراقبت فعلی شامل جایگزینی یک پروتئین لخته‌کننده خون به نام فاکتور ۹ است

🔹انتظار می‌رود که FDA در سه ماهه دوم ۲۰۲۴ تصمیم خود را درباره ژن‌درمانی فایزر بگیرد

🔹سازمان غذا و دارو آمریکا (FDA) در نوامبر ۲۰۲۲، نخستین ژن‌درمانی هموفیلی B را به نام Hemgenix محصول شرکت سی‌اس‌ال تائید کرد/رویترز

www.daroovasalamat.ir/fa/doc/news/52371
@phanair

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ژن‌درمانی آزمایشی فایزر برای هموفیلی B موفق عمل کرد 🔹فانا: فایزر روز پنجشنبه اعلام کرد ژن‌درمانی آزمایشی این شرکت برای درمان هموفیلی B به هدف اصلی خود در یک مطالعه فاز نهایی دست یافت 🔹داده‌های حاصل از این مطالعه نشان داد یک دوز واحد از این درمان نسبت به…

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کانادا ژن‌درمانی فایزر را برای هموفیلی B تائید کرد

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