Company | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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GeneLabs | Anastar | Prasterone, GL701; | Systemic lupus | European Agency for Evaluation of Medicinal Products determined that the marketing authorization application is complete; the review process has begun (1/9) |
CANCER |
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Aphton Corp. | G17DT | Anti-gastrin immunogen | Pancreatic | The Committee for Orphan Medicinal Products recommended to the European Commission that G17DT be granted orphan drug status (1/22) |
CARDIOVASCULAR |
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Dyax Corp. | DX-88 | A small protein that inhibits | Angiodema | The European Commission granted orphan medicinal product designation for DX-88 (1/8) |
CENTRAL NERVOUS SYSTEM |
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Labopharm Inc. | Tramadol | A once-daily formulation | Moderate to | Phase III results in Europe showed Labopharm's formulation achieved the primary endpoint of the study (1/22) |
INFECTION |
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NeuTec Pharma | AuroGrab | A recombinant antibody based on natural antibodies isolated from patients who recovered from MRSA | Methicillin- | Company will start a Phase IIb trial this quarter (1/22**) |
OraPharma | Arestin | Time-released antibiotic | Periodontal | Arestin was approved for sale in Sweden (1/22) |
Triangle | Coviracil | Emtricitabine; a nucleoside | HIV | Company submitted a marketing authorization application in Europe (1/7) |
MISCELLANEOUS |
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MoliChem | Moli | Duramycin; a muco-active | Cystic | Company received orphan drug designation in Europe for Moli1901 (1/8) |
Oxford Glyco- | Zavesca | Oral capsule formulation | Type I | Companies submitted an approval application in Israel (1/17) |
SangStat Medical | Acceptine | Cylosporine capsules | To prevent | Company filed a marketing authorization application in an undisclosed European country (1/22) |
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Notes: |
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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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LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange |