Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Allos Therapeutics Inc. | RSR13 | Synthetic small molecule that increases the release of oxygen from hemoglobin | Brain metastases | FDA designated RSR13 a fast-track product (11/8) |
Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham (NYSE:SBH) | Bexxar | Tositumomab, iodine I 131 tositumomab | Relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma | FDA accepted for filing the BLA (11/14) |
IDEC Pharmaceuticals Corp. (IDPH) | Zevalin | Ibritumomab tiuxetan; radioimmuno-therapeutic | B-cell non-Hodgkin's lymphoma | Company submitted a BLA to the FDA; FDA granted fast-track designation (11/1) |
Isis Pharmaceuticals (ISIP) | ISIS 3521 | Antisense drug; potent, selective inhibitor of protein kinase C-alpha (PKC alpha) expression | Non-small-cell lung cancer | FDA granted fast-track review status to ISIS 3521, which is in a Phase III trial with chemotherapy (11/8) |
NeoRx Corp. (NERX) | Skeletal Targeted Radiotherapy | Small-molecule carrier of the radionucleotide holmium-166 | Multiple myeloma | FDA suspended the Phase III trial after four patients who participated in the Phase I/II trial developed thrombotic throbocytopenic purpura/hemolytic uremic syndrome (11/7) |
Oxigene Inc. (OGNX) and Bristol-Myers Squibb Co. (NYSE:BMY) | Combretastatin A4 Prodrug | Systemic; antitumor vascular targeting agnet | Tumors | Company submitted an IND application for the systemic use of the compound (11/29) |
Vysis Inc. (VYSI) | UroVysion | Assay for monitoring recurrence of bladder cancer | Bladder cancer | Company submitted data to the FDA (11/30) |
CARDIOVASCULAR |
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Endovasc Ltd. Inc. (OTC BB:ENDV) | Liprostin | Developed using liposome drug deliver technology to encapsulate prostaglandin E-1, a potent vasodilator, platelet inhibitor and anti-thrombotic | Critical limb ischemia | FDA completed its final review of the company's IND and clinical Phase I and II trials are ready to begin (11/15) |
Eurogene Ltd. (UK)* | Trinam | Gene-based therapy; comprised of Eurogene's biodegradable collar/reservoir delivery device and a vascular endothelial growth factor gene | Hyperplasia in vascular anastomoses | FDA granted orphan drug designation to Trinam, which is in Phase I testing (11/28) |
United Therapeutics (UTHR) | UT-15 (Uniprost) | Analogue of prostacyclin, a molecule naturally produced | Pulmonary arterial hypertension | FDA accepted the NDA for filing (11/3); FDA said the UT-15 NDA will be reviewed before the Cardiovascular and Renal Drugs Advisory Committee at a meeting in early 2001 (11/8) |
DIABETES |
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Neurocrine Biosciences Inc. (NBIX) | NBI-6024 | Designed to induce an immune response capable of regulating autoreactive T cells involved in the destruction of (beta) islet cells of the pancreas | Type I diabetes | Company submitted an IND to the FDA, which approved it, allowing the company to begin a Phase I/II study (11/7) |
INFECTION |
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BioChem Pharma Inc. (Canada; BCHE; TSE:BCH) | Trizivir | Triple-drug therapy combining BioChem's Epivir and Retrovir with Glaxo Wellcome's Ziagen | HIV | FDA approved Trizivir (11/15) |
Gilead Sciences Inc. (GILD) | Tenofovir | Nucleotide analogue that blocks reverse transcriptase | AIDS | FDA granted fast-track status to tenofovir (11/10) |
Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Inc. (Switzerland) | Tamiflu | Oseltamivir phosphate | Flu prevention | FDA granted marketing approval (11/20) |
MISCELLANEOUS |
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Abgenix Inc. (ABGX) and SangStat Medical Corp. (SANG) | ABX-CBL | Murine anti-CD147 moncolonal antibody | Graft-vs.-host disease | FDA granted orphan drug status for ABX-CBL, which is in a Phase II/III study (11/30) |
Genzyme General (GENZ) | Fabrazyme | Agalsidase beta | Fabry disease | Company said the FDA said there is no need for a December advisory committee review of the BLA for Fabrazyme (11/1) |
Notes: |
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* Privately held **Denotes the date the item ran in BioWorld International |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
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BLA = Biologics License Application; NDA = New Drug Application |
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ND = Not disclosed |
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NCI/EORTC/AACR = National Cancer Institute/European Organization for Research and Treatment of Cancer/American Association for Cancer Research. |
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