Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Dusa Pharmaceuticals Inc. (DUSA) | Levulan Photodynamic Therapy | Aminolevulinic acid HCI | Dysplastic Barrett's esophagus | The University of Sheffield, UK, has published results of the first study in 36 subjects; a response was seen in 16 of 18 patients in the Levulan group, with a median decrease in Barrett's esophagus of 30%, compared to no decrease with the placebo group (12/11) |
Teva Pharmaceutical Industries Ltd. (Israel; TEVA) | Copaxone | Glatiramer acetate for injection | Relapsing-remitting multiple sclerosis | Company launched Copaxone in the UK (12/5) |
CENTRAL NERVOUS SYSTEM |
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Guilford Pharmaceuticals Inc. (GLFD) | GPI-15715; GPI-5693 | Prodrug anesthetic propofol; neuroprotectant | Neuropathic pain associated with diabetic peripheral neuropathy | Company submitted documentation to European authorities to begin clinical development of the two compounds (12/13) |
NicOx SA (France; Nouveau Marche:NICOX) | NCX701 | Nitric oxide-releasing derivative of paracetamol | Pain | Company began a Phase I trial in France (12/18) |
INFECTION |
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Cerus Corp. (CERS) | Intercept Platelet System | Designed to inactivate viruses, bacteria and other pathogens in plasma intended for transfusion | Blood infections | An independent Data and Safety Monitoring Board gave final clearance for the company to complete enrollment in its on-going Phase III trial (12/5) |
Gilead Sciences Inc. (GILD) | Adefovir dipivoxil | Reverse transcriptase inhibitor | Chronic hepatitis B virus | Company received approval from the People's Republic of China State Drug Administration to begin a Phase I trial in China in 2001 (12/11) |
Enzon Inc. (ENZN) and ICN Pharmaceuticals Inc. (NYSE:ICN) | Pegintron and Rebetol | Peginterferon alfa-2b injection; ribavirin capsules | Chronic hepatitis C | The European Agency for the Evaluation of Medicinal Products recommended approval of Pegintron and Rebetol as a combination therapy (12/20) |
Gilead Sciences Inc. (GILD) and F. Hoffmann-La Roche Ltd. | Tamiflu (FDA-approved) | Oseltamivir phosphate; neuraminidase inhibitor | Influenza A and B | Companies received regulatory approval in Japan (12/12) |
Hollis-Eden Pharmaceuticals Inc. (HEPH) | HE2000 | Compound thought to act by a mechanism of action that affects energy regulation in the host cell | Treatment-naive HIV | Phase I/II results of the South African trial indicated statistically significant increases in a number of immune system cell types (12/18) |
Vertex Pharmaceuticals Inc. (VRTX) | VX-148 | Small-molecule inhibitor of inosine monophosphate dehydrogenase | Viral infections, autoimmune | Company began its first human clinical trial in Europe (12/19) |
Visible Genetics Inc. (Canada; VGIN) | Trugene HIV-1 Genotyping Kit | Sequence based DNA test | HIV | Company was granted approval in France (12/21) |
MISCELLANEOUS |
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Access Pharmaceuticals Inc. (AMEX:AKC) and Strakan Ltd. | Zindaclin | Uses ResiDerm technology incorporating clindamycin in the zinc topical delivery system | Acne | Strakan filed a product license application in the UK (12/21) |
Alliance Pharmaceutical Inc. (ALLP) | Oxygent | Intravenous oxygen carrier; perflubron emulsion | To be used in patients under-going major surgical procedures | Analysis of Phase III data presented at the 54th Postgraduate Assembly in Anesthesiology showed that patients who lost a certain amount of blood and received Oxygent either completely avoided the need for blood more frequently than the control group, or required fewer units of blood (12/11) |
CIBA Vision Corp. (unit of Novartis AG; NYSE:NVS) and QLT Inc. (QLTI) | Visudyne (FDA-approved) | Verteporfin using photodynamic therapy | Choroidal neovascularization | The Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency has recommended the granting of a marketing authorization for Visudyne (12/15) |
Immunex Corp. (IMNX) | Enbrel (FDA-approved) | Etanercept | Rheumatoid arthritis | Health Canada approved Enbrel for use in Canada in adults for reduction in the signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to disease-modifying antirheumatic drugs (12/8) |
Inflazyme Pharmaceuticals Ltd. (Canada; TSE:IZP) | IPL576,092 | Oral therapy | Asthma | Company received approval to begin Phase II trials in the UK (12/22) |
International Wex Technologies Inc. (Canada; CDNX:WXI) | Tetrodin | Non-narcotic pharmaceutical developed from a naturally occurring organic substance | Opiate addictions | Company received permission to begin a Phase Ia trial in Canada (12/7) |
NicOx SA (France; Nouveau Marche:NICOX) | NCX1015 | Nitric-oxide-releasing derivative of prednisolone | Inflammatory bowel disease | Company began a Phase I trial in France (12/18) |
NicOx SA (France; Nouveau Marche:NICOX) | NCX1022 | Nitric oxide-releasing derivative of hydrocortisone | Psoriasis | Company began a Phase I trial in France (12/18) |
Procyon BioPharma Inc. (Canada; TSE:PBP) | Fibrostat | Topical cream | Severe scars | Company said an IND application was filed in Canada to complete Phase II studies of Fibrostat to treat severe scars resulting from surgery or burns (12/21) |
Serono SA (Switzerland; NYSE:SRA; SWX:SEO) | Luveris | Recombinant human luteinizing hormone | Infertility | Company received marketing approval in Europe (12/5) |
Serono SA (Switzerland; NYSE:SRA; SWX:SEO) | Ovidrel | Recombinant chorionic gonadotropin | Anovulation | Company received a recommendation for approval from the Committee for Proprietary Medicinal Products (12/5) |