Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE | ||||
Amgen Inc. | Enbrel | Etancercept; tumor | Psoriatic | Company submitted a supple- mental BLA to further expand the use of Enbrel to inhibit the progression of structural damage in psoriatic arthritis patients (10/25) |
Amgen Inc. | Kineret | Anakinra; a direct and | Rheumatoid | Company submitted a supplemental BLA to the FDA for use of the drug to inhibit progression of structural damage in adults with moderate to severe RA (10/23) |
Connetics Corp. | Olux | Topical treatment; | Non-scalp | FDA issued an approvable letter for the supplemental NDA to expand the label claims for Olux to include the treatment of non- scalp psoriasis (10/28) |
CANCER |
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AEterna | Neovastat | Anti-angiogenic | Renal cell | FDA granted Neovastat orphan drug status (10/29) |
Dendreon | Provenge | Therapeutic vaccine that appears to delay tumor progression | Hormone- | FDA gave clearance for the company to resume enrollment in its second Phase III trial following a six-month delay (10/28) |
ImClone | Erbitux | Cetuximab; designed to target and block the epidermal growth factor receptor | Colorectal | Company submitted two proto- cols for Phase III trials to the FDA (10/31) |
QLT Inc. | Tariquidar | A P-glycoprotein | Non-small- | FDA granted fast-track status; the product is in Phase III trials (10/3) |
CARDIOVASCULAR | ||||
Biopure Corp. | Hemopure | Hemoglobin glutamer- | Acute anemia | The FDA accepted the BLA for review (10/1) |
Icagen Inc.* | ICA-17043 | Small molecule that targets a specific ion channel, known as the Gardos channel, located on the membrane of red blood cells | Sickle-cell anemia | FDA granted fast-track designation for ICA-17043 (10/7) |
ISTA Pharmaceuticals Inc. (ISTA) | Vitrase | Injectable enzyme; | Vitreous | Company submitted to the FDA part of its NDA (10/1) |
INFECTION | ||||
Salix Pharma- | Rifaximin | Gastrointestinal tract- | Travelers' | FDA issued an approvable letter (10/25) |
Trimeris Inc. | Fuzeon | Enfurvitide; a fusion | HIV | FDA accepted the NDA for filing and granted Fuzeon piority review status (10/11) |
MISCELLANEOUS | ||||
TAP Pharma- | Uprima | Apomorphine HCl | Erectile | Company submitted a new drug application to the FDA for Uprima sublingual for the treatment of erectile dysfunction (10/29) |
Transkaryotic | Replagal | Enzyme replacement | Fabry's | FDA expressed concerns about some of the company's data in the BLA (10/3) |
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Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
