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Orphan Diseases Drug Development Weekly - Y2007 week 02
DATE
SOURCE
OTHER PARTY INVOLVED
INDICATION(S)
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01/12/07
Jazz Pharmaceuticals (US)
Valeant Pharmaceuticals (US)
Narcolepsy - cataplexy
Jazz Pharmaceuticals Signs Licensing Agreement With Valeant Pharmaceuticals for Canadian Marketing Rights to Xyrem(R)
01/12/07
Pipex Pharmaceuticals (US)
Effective Pharmaceuticals (US)
Acute refractory pouchitis
Pipex Pharmaceuticals Acquires Minority Interest in Its Effective Pharmaceuticals Subsidiary
01/12/07
Point Therapeutics (US)
Pancreatic cancer (metastatic)
Point Therapeutics Provides Preliminary Results from Phase 2 Metastatic Pancreatic Cancer Study
01/12/07
Valeant Pharmaceuticals (US)
Jazz Pharmaceuticals (US)
Narcolepsy - cataplexy
Valeant Pharmaceuticals Signs Licensing Agreement for Canadian Rights to (C)Xyrem® (Sodium Oxybate) from Jazz Pharmaceuticals
01/11/07
AnGes MG (JP)
Vical (US)
Melanoma (metastatic)
AnGes MG, Vical to Start Phase III Clinical Trial of Allovectin for Gene Therapy
01/11/07
Chelsea Therapeutics International (US)
Dainippon Sumitomo Pharma (JP)
Neurogenic orthostatic hypotension
Chelsea Therapeutics Announces Results of European Phase IIb Trial of Droxidopa
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
Genentech (US)
Various
Genentech Announces Full Year and Fourth Quarter 2006 Results
01/10/07
Insmed (US)
Cephalon (US)
Amyotrophic lateral sclerosis
Italian Ministry of Health Requests IPLEXTM for Treatment of ALS (Lou Gehrig’s Disease)
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
Actelion (CH)
CoTherix (US)
Pulmonary arterial hypertension
Actelion Ltd. Announces Successful Completion of its Cash Tender Offer for Shares of CoTherix, Inc.
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
Biogen Idec (US)
Multiple sclerosis
Biogen Idec Initiates Phase III Clinical Program of Oral Compound BG-12 for Multiple Sclerosis
01/09/07
Genzyme (US)
Various
Genzyme Reports Strong Fourth-Quarter Revenue Growth to Conclude Productive Year
01/09/07
GlaxoSmithKline (US)
Praecis Pharmaceuticals (US)
Non-Hodgkin's lymphoma
GlaxoSmithKline Commences Tender Offer to Acquire PRAECIS PHARMACEUTICALS
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…
01/09/07
sanofi-aventis (FR)
sanofi pasteur (FR)
Meningitis
Menactra(TM) vaccine available for meningitis prevention in Canada
01/08/07
Allos Therapeutics (US)
Lymphoma (peripheral T-cell)
Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 Trial of Its Novel Antifolate PDX in Patients With Peripheral T-cell…
01/08/07
Emory Eye Center (US)
Retinitis pigmentosa
Traditional Chinese Medicine Component May Yield Help in Retinal Degenerations
01/08/07
Human Genome Sciences (US)
Various
Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2007 Goals at JPMorgan Healthcare…
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
Seattle Genetics (US)
Genentech (US)
Various
Genentech and Seattle Genetics Announce Exclusive Global Licensing Agreement for Development and Commercialization of SGN-40
01/08/07
Vertex Pharmaceuticals (US)
Cystic fibrosis
Vertex Pharmaceuticals Announces 2007 Business Objectives at 25th Annual JPMorgan Healthcare Conference
01/08/07
Xanthus Pharmaceuticals (US)
Acute myeloid leukemia
Xanthus Receives Orphan Drug Designation of Xanafide for the Treatment Of AML