Company |
Product |
Description |
Indication |
Status (Date) |
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CANCER |
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GPC Bio- |
Bryostatin-1 |
Linked to the modulation of protein kinase C |
Esophageal cancer |
FDA granted orphan drug designation (12/12) |
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Guilford Pharm- |
Gliadel Wafer |
Carmustine |
Malignant glioma |
FDA's Oncologic Drugs Advisory Committee voted 8 to 5 in favor of using the Gliadel Wafer for newly diagnosed malignant glioma (12/6) |
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ImClone Systems |
Erbitux |
Monoclonal antibody designed to target and block the epidermal growth factor receptor |
Colorectal cancer |
FDA refused to accept the rolling BLA, delaying market launch by about six months; the FDA said the BLA contains insufficient data on response rates and eligibility requirements for patients entering the trial (12/31) |
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Praecis Pharma- |
Plenaxis |
Abarelix for injectable suspension |
Hormonally responsive advanced prostate cancer |
FDA granted the company approval to proceed with additional clinical trials to support an NDA (12/3) |
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DIABETES |
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Amylin Pharma- |
Symlin |
Pramlintide acetate |
Type I and Type II diabetes |
Company plans to conduct additional clinical trials requested by the FDA in its approvable letter, received in October (12/27) |
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MISCELLANEOUS |
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Avigen Inc. |
Coagulin-B |
Gene therapy treatment; adeno-associated virus vector containing the Factor IX gene, Coagulin-B, via infusion into the hepatic artery |
Hemophilia B |
Company received notice from the FDA that it can continue clinical testing following a trial suspension in October after a trace amount of DNA from the gene therapy was detected in the seminal fluid of the first patient to participate (12/19) |
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Cellegy Pharma- |
Anogesic |
Nitroglycerin ointment |
Pain associated with chronic anal fissures |
Company submitted a supplement to its NDA for Anogesic to include data from a recently completed confirmatory Phase III trial (12/3) |
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Notes: |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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FSE = Frankfurt Stock Exchange |
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BLA = Biologics License Application; NDA = New Drug Application |