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PRODUCT DEVELOPMENT » THERAPEUTICS
| Indication |
IC |
Licensee |
Product |
Phase
I |
Phase
II |
Phase
III |
NDA |
Market |
| Cancer |
NCI |
Schering AG |
Fludara® |
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| Cancer |
NCI |
Bristol-Myers Squibb |
Taxol® |
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| HIV |
NCI |
Barr Laboratories |
Didanosine Delayed-Release Capsules |
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| HIV |
NCI |
Roche Laboratories |
Hivid® |
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| HIV |
NCI |
Tibotec Pharmaceuticals |
Prezista® |
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| HIV |
NCI |
Bristol-Myers Squibb |
Videx® |
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| Multiple myeloma |
NCI |
Millennium Pharmaceuticals |
Velcade® |
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| Non-Hodgkin's lymphoma |
NCI |
Coulter Corporation |
Zevalin® |
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| Respiratory syncytial virus |
NIAID |
MedImmune |
Synagis® |
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| Severe mucositis associated with hematological cancers |
NCI |
Biovitrum |
Kepivance® |
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| Glioblastoma |
NCI
FDA |
Neo-Pharm |
Cintredekin Besudotox (IL13-PE38QQR) |
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| Metastatic melanoma |
NCI |
Medarex |
MDX-010 (gp100 peptide used in conjunction with Ipilimumab) |
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| Multiple myeloma |
NCI |
KOSAN Biosciences |
KOS-953 [17-AAG (tanespimycin)] |
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| Acute radiation syndrome |
NCI |
Humanetics |
BIO 300 |
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| Anemia associated with uterine fibroids |
NICHD |
Repros Therapeutics |
Proellex® |
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Anestic mild cognitive impairment (aMCI)
Schizophrenic related cognitive impairment |
NICHD |
Allon Therapeutics |
AL-108 (Davunitide intranasal) |
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Rheumatoid arthritis
Dry eye syndrome
Psoriasis |
NIDDK |
Can-Fite Biopharma |
CF101 |
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| Brain cancer |
NCI
NINDS |
Protox Therapeutics |
PRX321 |
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| Breast cancer |
NCI |
KOSAN Biosciences |
KOS-1022 [17-DMAG (alvespimycin)] |
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| Cancer |
NCI
FDA |
Ascenta Therapeutics |
AT-101 oral pan Bcl-2 inhibitor |
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| Cancer |
NCI |
Centocor |
CNTO 888 (anti-MCP-1) |
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| Cancer |
NCI |
Morphotek |
MORAb-009 |
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| HPV cervical dysplasia |
NCI |
Eisai Inc. |
Amolimogene (ZYC101a) |
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| Human papilloma virus |
NIAID |
Transgene S.A. |
TG 4001/R3484 |
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| Inflammatory bowel disease |
NIAID |
Abbott Bioresearch Center |
ABT-874 |
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Inflammatory bowel disease
Idiopathic pulmonary fibrosis |
NIAID |
Centocor |
CNTO 888 (anti-MCP-1) |
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| Lipoprotein lipase deficiency |
NHLBI |
Amsterdam Molecular Therapeutics |
Glybera® (AMT-011) |
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Liver cancer
Hepatitis C virus |
NIDDK |
Can-Fite Biopharma |
CF102 |
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| Lung cancer |
NIAID |
Transgene S.A. |
TG 4010 |
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| Mild cognitive impairment (MCI) as a complication of Coronary Bypass Graft Surgery (CABG) |
NICHD |
Allon Therapeutics |
AL-208 (Davunitide intravenous) |
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| Schizophrenia |
NIMH |
HoustonPharma |
Oral idazoxan |
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| Wound healing |
NIDCR |
RegeneRX Biopharmaceuticals |
Thymosin Beta 4 |
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| Alzheimer's disease |
NICHD |
Allon Therapeutics |
AL-108 (Davunitide intranasal) |
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| Cancer |
NCI |
Tigris Pharmaceuticals |
AFP-464 |
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| Cancer |
NCI |
MedImmune |
CAT-3888 (BL22) |
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| Cancer |
NCI |
MedImmune |
CAT-8015 (HA22) |
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| Cancer |
NCI |
Introgen Therapeutics |
DOTAP:Chol Fus1 liposomal complex |
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| Hepatitis C virus |
NIAID |
Transgene S.A. |
TG 4040 |
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| HIV |
NCI |
Sarawak MediChem Pharmaceuticals |
Calanolide A |
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| Hypertension |
NIEHS |
Arete Therapeutics |
AR9281 |
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| Inflammatory bowel disease |
NIAID |
SBL Vaccine AB |
Recombinant cholera toxin B-subunit |
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| Inflammatory diseases |
NICHD |
Clarassance |
rhCC10 uteroglobulin |
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| Tuberculosis |
NIAID |
Sequella |
SQ109 |
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PRODUCT DEVELOPMENT » VACCINES
| Indication |
IC |
Licensee |
Product |
Phase
I |
Phase
II |
Phase
III |
NDA |
Market |
| Hepatitis A virus |
NIAID |
GlaxoSmithKline |
Havrix® |
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| Hepatitis A & B viruses |
NIAID |
GlaxoSmithKline |
Twinrix® |
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| Hepatitis A virus & typhoid |
NIAID |
GlaxoSmithKline |
Hepatyrix® |
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| Human papilloma virus |
NCI |
GlaxoSmithKline |
Cervarix® |
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| Human papilloma virus |
NCI |
Merck |
Gardasil® |
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| Kidney cancer |
NIAID |
Oxford BioMedica |
TroVax® |
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| Kidney disease |
NICHD |
North American Biologicals |
StaphVAX® |
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| Hepatitis C virus |
NCI |
Intercell AG |
IC41 |
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| Hepatitis E virus |
NIAID |
GlaxoSmithKline |
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| HIV |
NIDDK |
Targeted Genetics |
tgAAC09 |
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| Hypertension |
NCI |
Cytos Biotechnology |
CYT006-AngQb |
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| Inflammatory arthritis |
NIDDK |
Targeted Genetics |
tgAAC94 |
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| Lung cancer |
NCI |
IDM Pharma |
IDM-2101 |
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| Parainfluenza virus type 3 |
NIAID |
MedImmune |
MEDI-534 |
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| Parvovirus B19 |
NHLBI |
Viral Antigens |
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| Cystic fibrosis |
NIAID
NCI |
Trinity Biosystems |
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| HIV |
NCI |
Novartis |
HIV Subtype B DNA-PLG and gp140 delta V2 protein vaccine |
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| HIV |
NCI |
Wyeth |
HIV-1 vaccine |
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| Meningitis |
NIDCD
FDA |
PATH |
Meningococcal Group A conjugate vaccine |
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PRODUCT DEVELOPMENT » DIAGNOSTICS/DEVICE PRODUCTS
REQUIRING IND/IDE/NDA REGULATORY PROCESSES
| Indication |
IC |
Licensee |
Product |
Phase
I |
Phase
II |
Phase
III |
NDA |
Market |
| Cancer |
NCI |
Ventana Medical Systems |
CONFIRM™ anti-HER-2 (CB11) PAB |
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Cancer |
NCI |
Ventana Medical Systems |
CONFIRM™ anti-C-erbB-2 |
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Cancer |
NCI |
Ventana Medical Systems |
CONFIRM™ anti-HER-2/neu (4B5) CE |
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Cancer |
NCI |
Ventana Medical Systems |
HER-2 FISH |
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Cancer |
NCI |
Ventana Medical Systems |
HER-2 SISH |
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Cancer |
NCI |
Ventana Medical Systems |
HER-2/neu Slides |
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Cancer |
NCI |
Ventana Medical Systems |
INFORM® HER-2 DNA Probe |
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Cancer |
NCI |
Ventana Medical Systems |
PATHWAY® anti-HER-2 PAB |
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Cancer |
NCI |
Ventana Medical Systems |
PATHWAY® anti-HER-2/neu (4B5) |
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Cancer |
NCI |
Ventana Medical Systems |
PATHWAY® HER-2/neu CPT |
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| Cardiovascular |
NIA |
Angiotech Pharmaceuticals / Boston Scientific |
TAXUS® paclitaxel-eluting stent systems |
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| Cardiovascular |
NIA |
Angiotech Pharmaceuticals / Cook Medical |
Zilver-PTX drug-eluting peripheral stent |
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| HIV |
NCI |
LabCorp |
GenoSURE™ |
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| HIV |
NCI |
LabCorp |
GenoSURE™ PLUS |
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| HIV |
NCI |
Abbott Labs |
HIV-1 diagnostic test |
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| HIV |
NCI |
PerkinElmer |
HIV-1 diagnostic test |
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| HIV |
NIAID
NCI
NIMH |
Monogram Biosciences |
HIV-1 genotyping and phenotyping |
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| HIV |
NCI |
Trinity Biotech |
Capillus™ HIV-1/HIV-2 antibody test |
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| HIV |
NCI |
Trinity Biotech |
Uni-Gold™ HIV-1/HIV-2 antibody test |
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| HIV |
NCI |
Trinity Biotech |
Uni-Gold™ Recombigen® HIV-1 antibody test |
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| HIV |
NCI |
Abbott Labs |
HTLV-I/II tests |
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| HTLV-I |
NCI |
bioMerieux |
Vironostika® HTLV-I / HTLV-II |
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| HTLV-III |
NCI |
OraSure Technologies |
OraQuick ADVANCE® Rapid HIV 1/2 Antibody Test |
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| HTLV-III |
NCI |
bioMerieux |
Vironostika® HIV-1 |
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| Research reagent |
NCI
NIAID |
BD Biosciences |
Cytochrome P450 isoenzymes |
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| Thyroid cancer |
NIDDK |
Genzyme Diagnostics |
Thyrogen® |
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| Colorectal cancer |
NCI |
Dow Chemical / Neoprobe |
RIGScan CR® (CC49) |
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| Drug delivery |
NINDS |
NeoPharm |
Delivery mechanism for Cintredekin Besudotox |
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| Cancer |
NCI |
BSD Medical Corporation |
BSD-2000/Sigma Eye |
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| Mental health |
NIDA
NINDS |
Brainsway |
Deep TMS H system |
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| Research tool |
NCI |
Ludwig Institute for Cancer Research |
CHX-A-DTPA |
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PRODUCT DEVELOPMENT » DIAGNOSTICS/DEVICE PRODUCTS
REQUIRING 510K REGULATORY PROCESSES
| Indication |
IC |
Licensee |
Product |
Prototype |
Registration Trial(s) |
510(k)/PMA Application |
Market |
| Breast cancer |
NCI |
Abbott Molecular |
Vysis Path Reagents |
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| Cancer |
NCI |
Fujirebio Diagnostics |
CA 72-4 in vitro radioimmunoassay |
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| Cancer |
NCI |
Stratagene |
QuikChange® XL Site-Directed Mutagenesis Kit |
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| Device |
NCI
NIBIB |
Molecular Devices Corporation |
PixCell laser capture microdissection system |
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| Imaging |
NHLBI |
General Electric |
Angiography MRI software |
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| Imaging |
NICHD |
General Electric |
MRI systems utilizing tensor diffusion pulse sequence |
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| Imaging |
NICHD
NINDS |
Siemens AG |
Diffusion tensor evaluation, imaging, and tractography software |
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| Imaging |
NHLBI |
Siemens Medical Solutions USA |
syngo imaging software |
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| Norwalk-like viruses |
NIAID |
R-Biopharm AG |
RIDASCREEN® Norwalk-like Virus ELISA |
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| Research reagent |
NCI |
BD Biosciences - BD PharMingen |
Interleukin-8 protein and antibodies |
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| Research reagent |
NIAID |
R&D Systems |
Interleukin-8 receptor |
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| Research reagent |
NIDDK |
GTC Biotherapeutics |
Transgenic milk expression kit |
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PRODUCT DEVELOPMENT » CONSUMER PRODUCTS
| Indication |
IC |
Licensee |
Product |
Development |
Market |
| Macular degeneration |
NEI |
Bausch & Lomb |
PreserVision® |
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PRODUCT DEVELOPMENT » VETERINARY PRODUCTS
| Indication |
IC |
Licensee |
Product |
Development |
Market |
| Equine West Nile virus vaccine |
NIAID |
Sanofi Pasteur Biologics |
PreveNile® 1D |
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| Equine West Nile virus vaccine |
NIAID |
Merial |
RECOMBITEK® |
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| Feline leukemia virus vaccine |
NIAID |
Merial |
PUREVAX® |
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| Rabies virus vaccine (oral) for wildlife |
NIAID |
Merial |
RABORAL V-RG® |
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