Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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CANCER | ||||
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Abraxis BioScience Inc. (ABBI) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) |
Metastatic breast cancer |
Australian regulatory authorities accepted for review its MAA (1/17) |
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Aida Pharmaceuticals Inc. (China; OTC BB:AIDA) |
Rh-Apo2L |
Apoptotic, gene therapy agent |
Cancer |
Received approval to begin Phase II trials in China (1/9) |
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Neose Technologies Inc. (NTEC) |
NE-180 |
Long-acting GlycoPEGylated erythropoietin |
Anemia in cancer |
Received approval from Swiss-medic for the start of a Phase II trial (1/16) |
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Oncolytics Biotech Inc. (Canada; ONCY) |
Reolysin |
Intratumorally delivered formulation of the human reovirus |
Advanced cancers |
Received clearance to begin a UK-based trial of Reolysin in combination with docetaxel (1/3) |
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OSI Pharmaceuticals Inc. (OSIP) and F. Hoffmann-La Roche Ltd. (Switzerland) |
Tarceva (FDA-approved) |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Metastatic pancreatic cancer |
European Commission granted marketing authorization of Tarceva in combination with gemcitabine as a first-line therapy (1/29) |
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Oxford BioMedica plc (UK; LSE:OXB) |
TroVax |
Immunotherapy vaccine that delivers an antigen (5T4) using a poxvirus vector |
Renal cancer |
The UK National Cancer Research Network adopted the Phase III TRIST trial (1/17)** |
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Pfizer Inc. (NYSE:PFE) |
Sutent |
Sunitinib; multiple receptor tyrosine kinase inhibitor |
Advanced and/or metastatic renal cell carcinoma |
European regulators approved Sutent for first-line use (1/18) |
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Pharmion Corp. (PHRM) and Celgene Corp. (CELG) |
Revlimid (FDA-approved) |
Lenalidomide; derivative of Thalomid (thalidomide) |
Multiple myeloma |
Filed for European approval (1/23) |
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CARDIOVASCULAR | ||||
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Biopure Corp. (BPUR) |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Acutely anemic orthopedic surgery patients |
UK authorities issued a letter with comments and questions regarding the company's MAA (1/9) |
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Chelsea Therapeutics International Ltd. (CHTP) |
Droxidopa |
Oral synthetic amino acid for neurogenic orthostatic hypertension |
Hypertension |
European Phase IIb trial showed statistical significance in reducing the fall in orthostatic systolic blood pressure in patients receiving 300 mg of the drug three times a day (1/12) |
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Cytori Therapeutics Inc. (CYTX) |
Adipose-derived stem and regenerative cells |
Cardiovascular disease |
Received approval to begin a trial in Spain (1/3) |
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ProMetic Life Sciences Inc. (Canada; TSX:PLI) |
PBI-1402 |
Orally active, low-molecular weight synthetic compound |
Anemia with chronic kidney disease |
Company received regulatory approval in Canada to expand the clinical program to include anemic patients; trial is evaluating PBI-1402 when added to erythropoietin (1/12) |
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Speedel Holding AG (Switzerland; PK:SPDHF) |
SPP1148 |
Renin inhibitor |
Hypertension and end-organ disease |
Started a Phase I trial (1/12) |
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UCB SA (Belgium; BR:UCB) |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Narcolepsy with cataplexy |
Committee for Medicinal Products for Human Use recommended that European regulators grant a marketing application for Xyrem (1/25) |
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DIABETES | ||||
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Living Cell Technologies Ltd.* (Australia) |
DiabeCell |
A porcine pancreatic cell product that involves injecting neonatal pig islet cells into the body to allow the release of insulin |
Type I diabetes |
Received approval to start a Phase I/IIa trial in Russia (1/30) |
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INFECTION | ||||
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Cangene Corp. (Canada; TSX:CNJ) |
HepaGam |
Hyperimmune product |
To prevent hepatitis B recurrence following liver transplantation |
Received approval from Health Canada (1/22) |
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CoGenesys Inc.* |
Neugranin |
Long-acting form of granulocyte colony stimulating factor |
To decrease the incidence of infection in those receiving myelo-suppressive anticancer drugs |
Applied to begin human studies in Europe (1/3) |
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MISCELLANEOUS | ||||
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Medivir AB (Sweden; SSE:MVIRB) |
MIV-701 |
Inhibitor of cathepsin K |
Osteoporosis, osteoarthritis, rheumatoid arthritis, Paget's disease and tumors |
Filed an application to begin a Phase I study in Europe (1/3) |
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Osiris Therapeutics Inc. (OSIR) |
Prochymal |
Adult stem cell product |
Acute graft-vs.-host disease |
Received orphan drug designation from the European Medicines Agency (1/16) |
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Shire plc (UK; product from former Transkaryotic Therapies Inc.) |
Elaprase (FDA-approved) |
Purified form of the lysosomal enzyme iduronate-2-sulfatase; produced by recombinant DNA technology in a human cell line |
Hunter syndrome |
Received marketing authorization from the European Commission (1/10) |
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Xytis Pharmaceuticals Inc.* |
Anatibant |
Selective, potent, small-molecule Bradykinin B2 receptor antagonist |
Traumatic brain injury |
Received approval to start a Phase II trial in the UK and South Africa (1/9) |
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Notes: | ||||
* Privately held. | ||||
CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
BR = Brussels Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange. | ||||
