Company* (Country; Symbol)




Status (Date)


Abraxis BioScience Inc. (ABBI)


Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

Metastatic breast cancer

Australian regulatory authorities accepted for review its MAA (1/17)

Aida Pharmaceuticals Inc. (China; OTC BB:AIDA)


Apoptotic, gene therapy agent


Received approval to begin Phase II trials in China (1/9)

Neose Technologies Inc. (NTEC)


Long-acting GlycoPEGylated erythropoietin

Anemia in cancer

Received approval from Swiss-medic for the start of a Phase II trial (1/16)

Oncolytics Biotech Inc. (Canada; ONCY)


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)

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)

Oxford BioMedica plc (UK; LSE:OXB)


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)**

Pfizer Inc. (NYSE:PFE)


Sunitinib; multiple receptor tyrosine kinase inhibitor

Advanced and/or metastatic renal cell carcinoma

European regulators approved Sutent for first-line use (1/18)

Pharmion Corp. (PHRM) and Celgene Corp. (CELG)

Revlimid (FDA-approved)

Lenalidomide; derivative of Thalomid (thalidomide)

Multiple myeloma

Filed for European approval (1/23)


Biopure Corp. (BPUR)


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)

Chelsea Therapeutics International Ltd. (CHTP)


Oral synthetic amino acid for neurogenic orthostatic 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)

Cytori Therapeutics Inc. (CYTX)

Adipose-derived stem and regenerative cells

Cardiovascular disease

Received approval to begin a trial in Spain (1/3)

ProMetic Life Sciences Inc. (Canada; TSX:PLI)


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)

Speedel Holding AG (Switzerland; PK:SPDHF)


Renin inhibitor

Hypertension and end-organ disease

Started a Phase I trial (1/12)

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)


Living Cell Technologies Ltd.* (Australia)


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)


Cangene Corp. (Canada; TSX:CNJ)


Hyperimmune product

To prevent hepatitis B recurrence following liver transplantation

Received approval from Health Canada (1/22)

CoGenesys Inc.*


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)


Medivir AB (Sweden; SSE:MVIRB)


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)

Osiris Therapeutics Inc. (OSIR)


Adult stem cell product

Acute graft-vs.-host disease

Received orphan drug designation from the European Medicines Agency (1/16)

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)

Xytis Pharmaceuticals Inc.*


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)


* Privately held.

CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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