Alligator Bioscience gains orphan designation for mitazalimab
Mitazalimab is a monoclonal antibody that has been created to sensitize tumours to chemotherapy
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Tag: orphan
US grants AZ’ Fasenra orphan drug status for rare autoimmune disease
US regulators have granted AstraZeneca’s Fasenra Orphan Drug Designation for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA), a rare and potentially fatal autoimmune disease.
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Five new medicines backed for EU approval
Five therapies have been backed for approval in the European Union, including two orphan medicines addressing rare conditions.
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Shire’s SHP647 bags another orphan badge
US regulators have awarded orphan drug status to Shire’s investigational therapy, SHP647, for the treatment of paediatric patients with moderately to severely active Crohn’s disease.
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Astellas bags orphan drug status for AML drug
Astellas’ experimental acute myeloid leukaemia drug gilteritinib has been awarded orphan drug designation by the European Commission.
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Orphan status for Shire’s experimental UC drug
US regulators have granted Shire’s investigational therapy SHP647 orphan status for the treatment of pediatric patients with moderately to severely active ulcerative colitis (UC).
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Shire’s haemophilia A gene therapy wins Orphan status
Shire’s gene therapy candidate SHP654, an investigational factor VIII (FVIII) gene therapy for the treatment of haemophilia A, has been awarded Orphan Drug Designation by US regulators
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US/EU orphan status for BI’s Ofev in systemic sclerosis
US and EU regulators have granted Orphan Drug Designation to Boehringer Ingelheim’s Ofev for the treatment of systemic sclerosis, including the associated interstitial lung disease.
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Experimental ALS drug wins EU orphan status
European regulators have assigned orphan drug status to an experimental therapy for Amyotrophic Lateral Sclerosis called masitinib, indicating that it has the potential to offer a significant benefit over existing treatment options.
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- MRM Health collaborates with Oncode Institute and Netherlands Cancer Institute
- Sobi to acquire Arthrosi Therapeutics, strengthening gout treatment pipeline
- Lindus Health and Quotient Sciences announce strategic partnership to accelerate drug development
- Title21 Health Solutions joins the Blood and Cells Advocacy Roster
- NADMED launches $30,000 metabolomics research award
