Company* | Product | Description | Indication | Status (Date) |
|
||||
CANCER |
||||
Amgen Inc. | Neulasta | Pegfilgrastim; | Cancer | FDA granted approval for Neulasta, which is injected once per chemotherapy cycle (2/1) |
Antigenics | Oncophage | Cancer vaccine; uses heat shock proteins to activate cellular immune responses | Metastatic | Company said the FDA granted fast-track designation for Oncophage (2/5) |
Corixa Corp. | Melacine | Vaccine consisting of lysed cells from two human melanoma cell lines combined with Corixa's Detox adjuvant | Melanoma | An FDA panel approved a proposed design for a second Phase III trial for the melanoma vaccine; company expects to include 700 patients in the trial (2/28) |
EntreMed | Endostatin | Naturally occurring angiogenesis inhibitor | Malignant | Endostatin received orphan drug status from the FDA (2/28) |
IDEC Pharma- | Zevalin | Monoclonal antibody linked to the radio- isotope Yttrium-90 that targets the CD20 antigen on the surface of mature B cells and B-cell tumors | Non-Hodgkin's lymphoma | FDA approved Zevalin (2/20) |
ImClone | Erbitux | Monoclonal antibody designed to target and block the epidermal growth factor receptor | Cancer | Company said the FDA might accept the Erbitux BLA with no new trials; the company plans to provide the agency with data from an ongoing European trial and reanalyzed data from U.S. Phase II trials (2/27) |
NeoPharm Inc. | SS1-PE38 | Antimesothelin monoclonal antibody | Mesothelioma and ovarian cancer | Company was granted orphan drug status by the FDA (2/14) |
CARDIOVASCULAR |
||||
United | Remodulin | Treprostinil sodium; subcutaneous | Pulmonary arterial hypertension | FDA issued an approvable letter (2/11) |
DIABETES |
||||
Ortec International | OrCel | Cryopreserved | Diabetic foot | FDA approved a pivotal trial (2/6) |
INFECTION |
||||
Gen-Probe | Procleix HIV-1/HCV Assay and the Procleix Semi-Automated System | A nucleic acid test system that detects viral genes rather than antibodies for screening donors | To detect viral genes for screening donors | FDA approved the HIV, HCV nucleic acid tests (2/28) |
INFLAMMATION AND PAIN | ||||
Centocor Inc. | Remicade (FDA-approved) | Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood | Rheumatoid | FDA approved Remicade, in combination with methotrexate, to improve physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone (2/28) |
Genmab A/S | HuMax-CD4 | Monoclonal antibody | Rheumatoid | FDA designated HuMax-CD4 a fast-track product (2/21) |
MISCELLANEOUS | ||||
Biosonix Ltd. | FlowGuard | Diagnostic product that employs the Angle- independent Doppler Blood Flow technology | To determine blood flow in noninvasive diagnostic and intraoperative applications | FDA approved the product (2/28) |
| ||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
CSE = Copenhagen Stock Exchange; OTC BB = Over the Counter Bulletin Board | ||||
BLA = Biologics License Application; NDA = New Drug Application |