Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Avax Technologies Inc. (AVXT) | O-Vax | Haptenized autologous cell vaccine | Ovarian cancer | FDA granted orphan drug status (9/27) |
Cell Pathways Inc. (CLPA) | Aptosyn | Small-molecule compound >that augments apoptosis | Familial polyposis | FDA told the company its NDA is not approvable due to deficiencies (9/22) |
Cell Therapeutics Inc. (CTIC) | Trisenox | Arsenic trioxide injection | Leukemia | FDA approved the drug to treat patients with a severe form of leukemia whose disease has recurred or who have failed to respond to standard therapy (9/26) |
Corixa Corp. (CRXA) | Melacine | Therapeutic cancer vaccine made of lysed cells from 2 melanoma cell lines with a broad array of melanoma antigens, combined with Detox adjuvant (contains monophosphoryl lipid A and mycobacterial cell-wall skeleton) | Melanoma | Company intends to file a BLA (9/27) |
Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham plc (NYSE:SBH) | Bexxar | Radioimmunotherapy involving antibody conjugated to iodine-131 | Non-Hodgkin's lymphoma | Company resubmitted BLA (9/18) |
IDEC Pharmaceuticals Corp. (IDPH) | Rituxan (FDA-approved) | Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface | Non-Hodgkin's lymphoma | Company received a completed review letter from FDA regarding a supplemental BLA (9/27) |
Immunomedics Inc. (IMMU) | LymphoCide | Lymphoma therapeutic; epratuzumab | B-cell lymphoma | Company said the FDA hold on clinical trials at the Garden State Cancer Center does not affect LymphoCide or any other products (9/22) |
Matrix Pharmaceutical Inc. (MATX) | IntraDose | Cisplatin/epinephrine injectable gel | Metastatic malignant melanoma | FDA granted orphan drug status (9/20) |
Maxim Pharmaceuticals Inc. (MAXM) | Maxamine | Histamine dihydrochloride | Advanced-metastatic melanoma | FDA designated Maxamine for priority review; NDA was submitted in July (9/7); company said the Oncology Drugs Advisory Committee will review the drug in December (9/18) |
SangStat Medical Corp. (SANG) | Thymoglobulin | Anti-thymocyte globulin (rabbit) | Myelodysplastic syndrome | FDA granted orphan drug designation for Thymoglobulin (9/18) |
CARDIOVASCULAR |
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Alexion Pharmaceuticals Inc. (ALXN) and Procter & Gamble Pharmaceuticals (NYSE:PG) | 5G1.1-SC | Monoclonal antibody that inhibits the fifth component of the complement cascade | Cardiopulmonary bypass surgery patients | FDA granted fast-track status and Alexion completed patient enrollment in a 1,000-patient Phase IIb trial (9/7) |
DIABETES |
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Keryx Biopharmaceuticals Inc. (KERX) | KRX-101 | Sulodexide | Diabetic nephropathy | FDA approved the company's plans to proceed to Phase III trials (9/27) |
INFECTION |
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Abbott Laboratories (NYSE:ABT) | Kaletra | Lopinavir/ritonavir; protease inhibitor | HIV | FDA approved Kaletra to treat HIV in adults and children in combination with other anti-retroviral medications (9/15) |
Glaxo Wellcome plc (NYSE:GLX) | Relenza | Zanamivir; neuraminidase inhibitor | Influenza strains A and B | Company submitted application for expanded approval (9/18) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Double-stranded synthetic RNA compound poly 1; poly C12U | Drug-resistant HIV | FDA authorized an advanced multicenter study to involve 100 patients (9/5) |
MISCELLANEOUS |
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Atrix Laboratories Inc. (ATRX) | Atrisorb FreeFlow and doxycycline | Guided tissue regeneration barrier with the antibiotic doxycycline | Tissue regeneration | Atrix received FDA clearance to market Atrisorb FreeFlow guided tissue regeneration barrier with the antibiotic doxycycline; Block Drug Corp. will market the product in the U.S. (9/13) |
Genelabs Technologies Inc. (GNLB) | GL701 | Dehydropieandosterone (DHEA); naturally occurring hormone produced by the adrenal glands | Systemic lupus erythematosus | Company submitted its NDA for marketing approval (9/26) |
GenStar Therapeutics (AMEX:GNT) | ND | Gene delivery system derived from the common cold virus | Hemophilia A | Company said its clinical protocol for a Phase I trial was reviewed by the National Institutes of Health Recombinant DNA Advisory Committee and an improved protocol was created (9/29) |
Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | FDA accepted the BLA for Fabrazyme; results from two clinical trials were presented at the International Congress of Inborn Errors of Metabolism (9/19) |
Gliatech Inc. (GLIA) | ADCON-L | Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) | Inhibition of post-surgical scarring and adhesions following back surgery | Company filed a response to the FDA concerning a post approval clinical trial of ADCON-L (9/15) |
InKine Pharmaceutical Co. (INKP) | Visicol | Tablet form (formerly Diacol) | For cleansing the bowel to prepare for colonoscopy | FDA approved Visicol (9/21) |
La Jolla Pharmaceutical Co. (LJPC) | LJP 394 | Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus kidney disease | FDA granted orphan drug designation for LJP 394 (9/6) |
Neurochem Inc. (TSE:NRM) | Fibrillex | Glycosaminoglycan (GAG) mimetic | Secondary amyloidosis | Company submitted an IND to begin Phase II/III trials (9/12) |
Palatin Technologies (ASE:PTN) | LeuTech | Monoclonal antibody | For diagnosing appendicitis | FDA requested additional manufacturing and process validation data for the BLA (9/28) |
Visible Genetics Inc. (VGIN) | Trugene HIV-1 Genotyping Kit and OpenGene DNA sequencing system | Designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations and indicate a treatment regimen | To identify genetic mutations in the HIV virus | Company submitted its application to the FDA (9/5) |
Vivus Inc. (VVUS) | Alista | Topical formulation of alprostadil | Female sexual dysfunction | Company filed an IND to begin clinical testing of Alista (9/21) |
Zonagen Inc. (ZONA) | Vasomax | Immediate-release, oral formulation of phentolamine | Erectile dysfunction | FDA told the company that a shorter mechanistic study of brown fat proliferation may be submitted in lieu of a 2-year rodent study in order to lift the partial clinical hold on Vasomax (9/7) |
Notes: |
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* Privately held |
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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; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
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IND = Investigational New Drug Application |
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BLA = Biologics License Application |
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NDA = New Drug Application |
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ND = Not disclosed |
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PMA = Pre-market Approval Application |
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SSAHA=Scientific Session of the American Heart Association. |
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ICAAC=Interscience Conference on Antimicrobial Agents and Chemotherapy. |
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