Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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AnorMED Inc. (Canada; TSE:AOM) | ZDO437 | Platinum-based anticancer agent | Cancer | In a Phase I trial, the drug proved negative for nephrotoxicity or neurotoxicity, showing only short-lived hematological toxicity (11/10) |
Cell Therapeutics Inc. (CTIC) | Trisenox (FDA-approved) | Arsenic trioxide injection | Relapsed acute promyelocytic leukemia | Company submitted a marketing authorization application in Europe (11/14) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors | Advanced-stage cutaneous T-cell lymphoma | The Committee for Proprietary Medicinal Products recommended granting European marketing authorization of Targretin to treat skin manifestations of lymphoma patients refractory to at least one systemic treatment (11/21) |
CARDIOVASCULAR |
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Actelion Pharmaceuticals Ltd. (Switzerland; SWX:ATLN) | Tracleer | Bosentan; orally active endothelin receptor antagonist | Pulmonary hypertension | Company plans to file an NDA following Phase III data that indicated patients experienced a 20% increase in exercise ability after 12 weeks of therapy (11/14) |
Centaur Pharmaceuticals Inc.* and AstraZeneca Inc. (UK; NYSE:AZN) | NXY-059 | Small-molecule, intravenously delivered modifier of the cellular response to stress agents that damage and kill cells | Stroke | Companies received Japanese regulatory approval to begin a Phase I trial (11/29) |
INFECTION |
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Enzo Biochem Inc. (NYSE:ENZ) | ND | Immune regulation medicine; stems from the company's work in EHT899 | Hepatitis C or associated hepatocellular carcinoma | Company received approval from Israel's Ministry of Health to begin a Phase I trial (11/30) |
Virax Holdings Ltd. (Australia; ASX:VHL) | VIR201 | Fowlpox virus delivered with Co-X-Gene vaccine delivery technology | HIV | Company received approval to begin clinical trials on patients recently infected with HIV (11/28) |
MISCELLANEOUS |
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Access Pharmaceuticals Inc. (AMEX:AKC) | Zindaclin | ResiDerm incorporating clindamycin | Acne | The primary endpoint, the change in total facial inflammatory lesion counts from the baseline visit to the end of 16 weeks of treatment, was achieved in the Phase III European clinical trial (11/10) |
Bio-Technology General Corp. (BTGC) | BioHy | Injectable formulation of high-molecular-weight sodium hyaluronate | Osteoarthritis | Company received marketing approval in Europe (11/14) |
Cellegy Pharmaceuticals Inc. (CLGY) | Rectogesic | Nitroglycerin ointment | Anal fissures | Cellegy filed for marketing approval of Rectogesic in New Zealand (11/14) |
Columbia Laboratories Inc. (AMEX:COB) | Testosterone hydration buccal tablet | Testosterone | Testosterone-deficiency | Company began Phase III trials in Europe (11/21) |
Neurochem Inc. (Canada; TSE:NRM) | Fibrillex | Anti-amyloid drug | Secondary amyloidosis | Company submitted an application in the UK to initiate a pivotal Phase II/III study there (11/8) |
NexMed Inc. (NEXM) | Befar | Alprostadil cream | Erectile dysfunction | Company presented Phase III results that indicated the compound was statistically significant; the 160-man study was conducted as part of the final regulatory approval process in China (11/29) |