Company (Symbol)* |
Product |
Description | Indication |
Action/Date** |
CANCER | ||||
Inex Pharmaceuticals Corp. (Canada; TSE: IEX) | Onco TCS | Vincristine encapsulated in Transmembrane Carrier Systems drug delivery technology | Second-relapsed aggressive non-Hodgkin's lymphoma |
Received approval to commence Phase II/III trial (11/1) |
LorusTherapeutics Inc. (Canada; TSE:LORFF) |
GTI 2040 | Antisense anticancer therapeutic |
Various cancers | Filed investigational new drug (IND) application (11/16) |
Xenova Group plc (UK; LSE:XEN) |
XR9576 |
P-glycoprotein pump inhibitor that restores the sensitivity of multi-drug resistant cancer cells to specific cytotoxic drugs |
Various cancers | Received IND approval (11/24) |
CARDIOVASCULAR | ||||
AVI BioPharma | Resten-NG | Gene-targeted therapeutic drug | Restenosis following angioplasty | Filed IND (11/16) |
Endovasc Ltd. Inc. | Liprostin (OTC BB:ENDVE) |
Liposomal encapsulation of prostaglandin E-1 (PGE-1) |
Peripheral arterial occlusive disease | FDA granted approval to begin Phase III studies contingent on the company expanding its trials to include additional placebo arms (11/4) |
CENTRAL NERVOUS SYSTEM | ||||
Gliatech Inc. (GLIA) | Perceptin | Selective histamine H3 receptor antagonis |
Various central nervous system disorders | Received IND approval to initiate Phase II trials (11/22) |
INFECTION | ||||
Agouron Pharmaceuticals Inc. (a subsidiary of Warner-Lambert Co.; NYSE:WLA) |
Viracept |
Synthetic small molecule designed to inhibit HIV protease | HIV infection | FDA approved twice-daily dosing regimen (11/29) |
Gilead Sciences (GILD) | Adefovir dipivoxil 60 mg; reverse transcriptase inhibitor | HIV infection | Presented safety and efficadata to the FDA's antiviral drugs advisory committee, which recommended that the FDA not approve the drug (11/1) |
|
Immunomedics Inc. (IMMU) |
LeukoScan | Sulesomab; monoclonal antibody fragment labeled with technetium-99 that binds to white blood cells |
Various infectious diseases |
FDA informed the company of deficiencies in its product filing (11/29) |
Palatin Technologies Inc. (PLTN) |
LeuTech | Antibody-based infection imaging agent |
Diagnosis of equivocal appendicitis | Submitted biologics license application (BLA) (11/23) |
MISCELLANEOUS | ||||
Advanced Polymer Systems Inc. (APOS) |
Microsponge-entrapped 5-fluorouracil |
Actinic keratoses |
Submitted new drug application (NDA) (11/1) | |
Amgen Inc. (AMGN) | Epogen |
Recombinant human erythropoeitin | Anemia in children with chronic renal failure who are undergoing kidney dialysis |
Approved for the treatment of children (11/3) |
Avanir Pharmaceuticals (OTC BB:AVNR) | Docosanol 10% cream |
Oral-facial herpes |
FDA provided preliminary results of the company's appeal regarding its NDA (11/1) | |
Boston Life Sciences Inc. (BLSI) | Altropane | Radioimaging probe for dopamine neurons |
Attention deficit hyperactivity disorder |
Submitted proposed Phase II study (11/23) |
Centocor Inc. (a subsidiary of Johnson & Johnson.; NYSE:JNJ) | Remicade | Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha |
Rheumatoid arthritis |
Received marketing approval |
Ciba Vision (a subsidiary of Novartis AG) and QLT PhotoTherapeutics Inc. (QLTI) | Visudyne |
Verteporfin; light-activated drug for photodynamic therapy | Wet age-related macular degeneration |
FDA advisory panel recommended approval (11/17) |
Genelabs Technologies Inc. (GNLB) | GL701 | Dehydroepiandosterone; (naturally occurring hormone produced by the adrenal glands) | Systemic lupus erythematosus | FDA deemed the company's NDA adequate for submission (11/22) |
InKine Pharmaceutical Co. Inc. (INKP) | Diacol |
Sodium phosphate tablets | Adult patients under-evaluation going colonoscopic | Submitted NDA (11/23) |
Ortec International Inc. (ORTC) |
Composite Cultured Skin |
Tissue-engineered dressing | Epidermolysis Bullosa, consisting of two layers of human-derived skin cells (dermal and epidermal) supported with a porous collagen matrix | Filed for marketing approval Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Erythema Multiforme |
OrthoLogic Corp. (OLGC) | Chrysalin | Synthetically manufactured peptide that mimics attributes of the thrombin molecule by interacting with specific receptors on cells involve in tissue repair | Acceleration of fracture healing |
FDA granted permission to proceed with Phase I/II trials (11/9) |
Xoma Ltd. (XOMA) | Neuprex |
Recombinant bactericidal/permeability increasing protein |
Severe pediatric meningococcemia | Submitted analysis of data from Phase III trial (11/11) |
Notes: | ||||
* Indicates a privately held company. | ||||
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange | ||||
ND = Not Disclosed |
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