Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
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Abbott Laboratories (NYSE:ABT) |
Humira (FDA-approved) |
Adalimumab; tumor necrosis factor-alpha blocker agonist |
Crohn's disease |
Received marketing authorization from the European Commission (6/7) |
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Centocor Inc. (unit of Johnson & Johnson) and Schering-Plough Corp. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor alpha |
Crohn's disease |
European Commission approved Remicade (6/7) |
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Isotechnika Inc. (Canada; TSX:ISA) |
ISA247 |
Immunosuppressive agent |
Moderate to severe psoriasis |
Received approval from Polish regulators for participation in the ongoing Phase III European/Canadian trial (6/6) |
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CANCER | ||||
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Celgene International Sarl (Switzerland; subsidiary of Celgene Corp.; CELG) |
Revlimid (FDA-approved) |
Lenalidomide |
Multiple myeloma |
Was granted full marketing authorization by the European Commission for use in combination with dexamethasone (6/19) |
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Cephalon Inc. (CEPH) |
Treanda |
Bendamustine; hybrid cytotoxic alkylating agent |
Chronic lymphocytic leukemia |
European Phase III trial met its primary endpoint of overall response rate (6/28) |
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Favrille Inc. (FVRL) |
FavId |
Patient-specific immuno-therapy |
Indolent B-cell non-Hodgkin's lymphoma |
Phase II data from the European trial showed clinical responses with FavId (6/11) |
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Oncolytics Biotech Inc. (Canada; ONCY; TSX:ONC) |
Reolysin |
Formulation of the human reovirus |
Advanced cancers |
Started enrolling patients in its UK trial (6/11) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer HealthCare Pharmaceuticals Inc. |
Nexavar (FDA-approved) |
Sorafenib tablets |
Hepatocellular carcinoma |
Bayer submitted an MAA (6/19) |
Pharmion Corp. (PHRM) |
Satraplatin |
Oral platinum compound |
Metastatic hormone-refractory prostate cancer |
Submitted an MAA with the EMEA for satraplatin in combination with prednisone (6/26) |
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Pharmion Corp. (PHRM) |
Thalomid |
Thalidomide |
Multiple myeloma |
French authorities granted a temporary authorization for use (6/4) |
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Vakzine Projekt Management GmbH* (Germany) |
VPM4001 |
Immunotherapeutic |
Hormone-resistant prostate cancer |
Phase I/II data showed that 73% of patients responded positively to therapy (6/1) |
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Wex Pharmaceuticals Inc. (Canada; TSX:WXI) |
Tectin |
Tetrodotoxin; non-narcotic agent |
Cancer-related pain |
Received a No Objection letter from Health Canada for a 120-patient Phase III trial (6/13) |
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YM BioSciences Inc. (Canada; AMEX:YMI; TSX:YM) |
Nimotuzumab |
A humanized monoclonal antibody that targets the epidermal growth factor receptor |
Colorectal cancer |
YM received a No Objection letter from Health Canada to its proposed Phase II trial of the therapy with irinotecan (6/4) |
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CARDIOVASCULAR | ||||
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Speedel Holding AG (Switzerland; SWX:SPPN) and Novartis AG (Switzerland) |
SPP100 |
Rasilez; a first-in-class once-daily direct renin inhibitor |
Hypertension |
Received a positive opinion recommending European Union approval of SPP100 (6/22) |
CENTRAL NERVOUS SYSTEM | ||||
7TM Pharma A/S* (Denmark) |
Obinepitide |
TM30338; an analogue of two hormones released in connection with food intake |
Obesity |
Started a 180-patient Phase II trial in Sweden (6/12) |
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Alexion Pharmaceuticals Inc. (ALXN) |
Soliris (FDA-approved) |
Eculizumab |
Paroxysmal nocturnal hemoglobinuria |
European Commission approved Soloris (6/22) |
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Labopharm Inc. (Canada; DDSS) |
Tramadol |
Once-daily formulation |
Moderate pain |
Received a notice of compliance from Health Canada for 100-mg, 200-mg and 300-mg tablets (6/18) |
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DIABETES | ||||
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Living Cell Technologies Ltd.* (Australia) |
DiabeCell |
Pig pancreatic cell product |
Type I diabetes |
Dosed the first patient in a Phase I/IIa trial in Moscow (6/14) |
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INFECTION | ||||
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Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) and Janssen-Cilag International NV (Belgium) |
Ceftobiprole |
Broad-spectrum, anti-MRSA cephalosporin antibiotic |
Complicated skin and soft tissue infections |
Submitted a marketing authorization application to the EMEA (6/18) |
Dynavax Technologies Corp. (DVAX) |
Heplisav |
Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9 |
Hepatitis B virus |
Enrollment in a pivotal study started in Germany (6/27) |
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Hemispherx Biopharma Inc. (AMEX:HEB) |
Ampligen |
Toll-like receptor 3 ligand designed to function as an immune system activator |
Influenza |
Started an Australian Phase IIb trial (6/26) |
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Shire plc (UK) |
Elaprase (FDA-approved) |
A human enzyme replacement therapy |
Hunter syndrome |
Health Canada approved Elaprase (6/14) |
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Notes: | ||||
* Privately held. | ||||
CMPH = 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. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||