Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE | ||||
Biogen Inc. (BGEN) | Amevive | Alefacept; novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells | Psoriasis | FDA told Biogen it expects to finish its review of the application for Amevive within six months (9/13) |
CANCER |
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MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) | Palonosetron | Differentiated 5-HT3 | Chemotherapy- induced nausea and vomiting | Companies submitted an NDA (9/27) |
OSI Pharmaceuticals | Tarceva | Erlotinib HCl; small-molecule epidermal growth factor receptor inhibitor | Non-small-cell lung cancer | FDA designated Tarceva as a fast-track product for second- or third-line treatment of pa- tients with incurable stage IIIB/ IV non-small-cell lung cancer who have failed standard therapy (9/23) |
PhotoCure ASA (Norway; OSE:PH) | Metvix | Photodynamic therapy; cream that is absorbed into the cancer cells, followed by activation of the drug through illumination with a red light source called Curelight | Premalignant skin changes or actinic keratosis | FDA approved Metvix PDT, though certain items must be resolved before final marketing approval can be granted (9/23) |
CENTRAL NERVOUS SYSTEM | ||||
Forest Laboratories Inc. (NYSE:FRX) | Memantine | Orally available neuro- protective agent that appears to restore dam- aged nerve cells and block excitatory signals by modulating the N-methyl D-aspartate receptor on cell membranes | Alzheimer's disease | Company withdrew its NDA in order to correct structural and formatting problems identified by the FDA (9/23) |
INFECTION | ||||
Genzyme General (GENZ) and Bio- | Aldurazyme | Enzyme replacement | Mucopoly- | FDA accepted the BLA and granted six-month priority review status (9/16) |
Gilead Sciences | Hepsera | Adefovir dipivoxil | Chronic | FDA approved Hepsera (9/23) |
Triangle Pharmaceuticals | Coviracil | Emtricitabine; a nucleoside reverse transcriptase inhibitor | HIV | Company filed an NDA (9/5) |
Trimeris Inc. | Fuzeon | A fusion inhibitor | HIV | Companies filed an NDA (9/17) |
MISCELLANEOUS |
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ISTA Pharmaceuticals Inc. (ISTA) and Senju Pharmaceuticals Co. Ltd. (Japan) | Istalol | Formulation of timolol | Glaucoma | Companies submitted an NDA (9/27) |
Novavax Inc. | Estrasorb | An estradiol topical emulsion being | To reduce vasomotor symptoms in menopausal women | Company submitted an NDA to the FDA (9/10) |
Tanox Inc. | TNX-901 | A humanized anti-IgE | Peanut allergies | FDA granted fast-track status (9/24) |
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Notes: | ||||
* Privately held |
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** 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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OSE = Oslo Stock Exchange; NYSE = New York Stock Exchange |
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