| Company* | Product | Description | Indication | Status (Date) |
| | ||||
CANCER | ||||
| Amgen Inc. | Aranesp (FDA- | Darbepoetin alfa | Anemia associated with chemotherapy | Company submitted a variation application to the European Agency for the Evaluation of Medicinal Products to expand the clinical indication for Aranesp (10/23) |
| Cell Thera- | Trisenox (FDA- | Arsenic trioxide injection | Relapsed/refractory acute promyelocytic leukemia | The European Union's Committee for Proprietary Medicinal Products recommended approval (10/18) |
| Immuno- | IDM-1 | Antibody-based cell drug | Ovarian cancer | Company received approval in Canada to begin Phase III trials (10/30) |
| Micromet | MT201 | Human antibody | Cancer | Company began a multicenter Phase I trial (10/31**) |
| Novus- | BBR | Administered as a one-hour intravenous infusion | Non-Hodgkin's lymphoma | Phase II data showed six of 27 patients responded to treatment; study was in Germany and France (10/1) |
| Oncolytics | Reolysin | Reovirus, which targets solid tumors with an activated Ras gene pathway | T2 prostate cancer | Company gained approval in Canada to initiate a clinical study (10/11) |
CENTRAL NERVOUS SYSTEM | ||||
| Theratechnol- | ThGRF | Growth hormone-releasing factor analogue | Insomnia | Company said two European clinical sites, in Belgium and the UK, have been added to the Phase II trial; enrollment has begun in Europe (10/25) |
INFECTION | ||||
| Gilead Sciences | Viread | Tenofovir disoproxil fumarate | HIV | The European Union's Committee for Proprietary Medicinal Products recommended granting marketing authorization (10/18) |
| Tibotec-Virco | TMC125 | A non-nucleoside reverse transcripase inhibitor | HIV | In a trial conducted in Russia, the drug demonstrated an average reduction in the amount of HIV in patients' plasma of 99% after one week (10/29) |
MISCELLANEOUS | ||||
| Access Phar- | Zindaclin | Incorporates clindamycin within Strakan's ResiDerm topical delivery system | Acne | Strakan received marketing authorization in the UK for Zindaclin (10/24) |
| Immtech | DB289 | Oral, anti-infective | African sleeping sickness (trypanosomiasis) | Company initiated a Phase II study in Africa (10/1) |
| InKine Phar- | Visicol (FDA- | Tablet form (formerly Diacol | Bowel cleansing prior to colonoscopy | Company submitted a marketing authorization application in the UK (10/1) |
| Isotechnika | ISATX | Immunosuppressive drug | Psoriasis | Canadian Phase II trials have begun (10/3) |
| SangStat | RDP58 | A rationally designed peptide; a novel inhibitor of tumor necrosis factor alpha synthesis | Crohn's disease and ulcerative colitis | Company is initiating two Phase II studies in the UK (10/22) |
| Transkary- | Replagal | Enzyme replacement therapy | Fabry's disease | Company received marketing approval of Replagal in New Zealand and Iceland (10/19) |
| Unigene | Forcal- | Injectable calcitonin product | Osteoporosis | Company received approval in Switzerland (10/2) |
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| 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; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange |
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