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Gan & Lee receives EMA orphan drug designation for Phase I drug [...] | Comunicati stampa CataniaOggi


06 aprile 2021 13:40
Fonte: Adnkronos
#salute-e-benessere
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BEIJING, and BRIDGEWATER, N.J., April 6, 2021 /PRNewswire/  Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, today announced that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug designation for the investigational compound GLR2007, for the treatment of glioma.
Glioma is a broad term describing neuroepithelial tumors originating from glial cells of the central nervous system, including astrocytic tumors such as glioblastomas (GBM). GBM is one of the most aggressive primary brain tumors and has median survival of 12 to 15 months, despite advances in surgery, chemotherapy, and radiation therapy1.  Gan & Lee s current clinical development program for GLR2007, a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, is investigating the treatment of advanced solid tumors which ....

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Gan & Lee receives EMA orphan drug designation for Phase I drug candidate GLR2007 for the treatment of glioma


Gan & Lee receives EMA orphan drug designation for Phase I drug candidate GLR2007 for the treatment of glioma
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BEIJING and BRIDGEWATER, N.J., April 6, 2021 /PRNewswire/  Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, today announced that the European Medicine Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug designation for the investigational compound GLR2007, for the treatment of glioma.
Glioma is a broad term describing neuroepithelial tumors originating from glial cells of the central nervous system, including astrocytic tumors such as glioblastomas (GBM). GBM is one of the most aggressive primary brain tumors and has median survival of 12 to 15 months, despite advances in surgery, chemotherapy, and radiation therapy ....

Gina Antonucci , Michelle Mazuranic , Head Of Global Medical Affairs , Committee For Orphan Medicinal Products , Gan Lee Pharmaceuticals Co Ltd , European Union , Health Technology Assessments , European Commission , European Medicine Agency , Orphan Medicinal Products , Global Medical Affairs , Orphan Medicinal , Ganlee Fine , ஜினா அன்டோனூசி , தலை ஆஃப் உலகளாவிய மருத்துவ வாழ்க்கைத்தொழில்கள் , குழு க்கு ஆர்ஃபந் மருத்துவ ப்ராடக்ட்ஸ் , கண் லீ மருந்துகள் இணை லிமிடெட் , ஐரோப்பிய தொழிற்சங்கம் , ஆரோக்கியம் தொழில்நுட்பம் மதிப்பீடுகள் , ஐரோப்பிய தரகு , ஆர்ஃபந் மருத்துவ ப்ராடக்ட்ஸ் , உலகளாவிய மருத்துவ வாழ்க்கைத்தொழில்கள் , ஆர்ஃபந் மருத்துவ ,

Passage Bio Receives European Commission Orphan Designation for PBKR03 for Treatment of Krabbe Disease


- Urgency for effective treatment underscored by European Commission designation for investigational gene therapy PBKR03
- Global Phase 1/2 trial – GALax-C – PBKR03 planned to initiate in first half of 2021
PHILADELPHIA, April 05, 2021 (GLOBE NEWSWIRE) Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that the European Commission has granted Orphan designation for PBKR03, an adeno-associated virus (AAV)-delivery gene therapy for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products. Currently, there are no approved disease-modifying therapies available for Krabbe disease, a rare lysosomal storage disease that most often presents early in a child’s life. The U.S. Food and Drug Administrat ....

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