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Orphan Diseases Drug Development Weekly - Y2007 week 02
DATE
SOURCE
OTHER PARTY INVOLVED
INDICATION(S)
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01/11/07
Shire (UK)
Hunter syndrome
The European Commission Approves First and Only Enzyme Replacement Therapy for Hunter Syndrome
01/10/07
EMEA - COMP (UK)
ACE Pharmaceuticals (NL)
Malaria
Committee for Orphan Medicinal Products January 2007 Meeting
01/10/07
EMEA - COMP (UK)
Immatics Biotechnologies (DE)
Renal cell carcinoma
Committee for Orphan Medicinal Products January 2007 Meeting
01/10/07
EMEA - COMP (UK)
Santhera Pharmaceuticals (DE)
Leber's hereditary optic neuropathy
Committee for Orphan Medicinal Products January 2007 Meeting
01/10/07
EMEA - COMP (UK)
Pharming Group (NL)
Delayed graft function post organ transplantation
Committee for Orphan Medicinal Products January 2007 Meeting
01/10/07
Viralytics (US)
Melanoma (metastatic)
Ethics Committee Approval to conduct a Phase I study in Breast, Prostate and Melanoma Cancer patients using CAVATAKTM administered intravenously
01/09/07
Anthera Pharmaceuticals (US)
Acute chest syndrome
Anthera Receives IND Approval from FDA to Begin Phase 2 'IMPACTS' Trial With A-001 for Prevention of Acute Chest Syndrome in Patients with Sickle Cell…
01/09/07
Medarex (US)
BioWa (US)
Hodgkin's disease (relapsed or refractory)
BioWa and Medarex Announce Allowance of Investigational New Drug Application for Second-Generation Anti-CD30 Antibody (MDX-1401) Enhanced…
01/08/07
Osiris Therapeutics (US)
Crohn disease
Osiris Therapeutics Receives FDA Fast Track Status for Its Crohn’s Disease Stem Cell Therapy and Clearance to Start Phase III Clinical Trial
01/08/07
Provectus Pharmaceuticals (US)
Melanoma (metastatic)
Provectus Receives Orphan Drug Designation from FDA for Anti-Cancer Agent PV-10 for the Treatment Of Metastatic Melanoma
01/08/07
Xanthus Pharmaceuticals (US)
Acute myeloid leukemia
Xanthus Receives Orphan Drug Designation of Xanafide for the Treatment Of AML