| Company* | Product | Description | Indication | Status (Date) |
CANCER | ||||
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| Amgen Inc. | Aranesp | Darbepoetin alfa | Anemia associated with certain types of chemotherapy | Company submitted a BLA (9/20) |
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| Atrix Lab- | Leuprogel Three-Month Depot | Atrigel formulation containing leuprolide acetate; injected subcutaneously | Prostate cancer | Company submitted an NDA (9/26) |
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| Avax | M-Vax and | Cancer vaccines that work by using the patient's own cells, which are modified with a hapten molecule so that the tumor cells appear foreign to the body | Melanoma and ovarian cancer | FDA has requested more information before releasing a clinical hold (9/21) |
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| Corixa Corp. | Bexxar | Radioimmunotherapy antibody conjugated to iodine-131 | Relapsed or refractory low-grade or transformed low-grade non-Hodgkin's lymphoma | Companies submitted the final responses to information requested by the FDA in its complete review letter received March 16 (9/7) |
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| Genta Inc. | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Multiple myeloma, acute myelocytic leukemia and chronic lymphocytic leukemia | FDA granted Genasense orphan drug status (9/4); FDA gave it fast-track designation (9/20) |
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| IDEC | Zevalin | Radioimmunotherapy; mouse monoclonal antibody targeted against the CD20 antigen and conjugated to a yttrium-90 radioisotope; administered with Rituxan | Non-Hodgkin's lymphoma | The Oncologic Drugs Advisory Committee recommended approval of Zevalin (9/11) |
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| Matrix | IntraDose Injectable | Biodegradable gel containing cisplatin and epinephrine | Head and neck cancer | FDA medical reviewers recommended rejection of the product (9/7); the Oncologic Drugs Advisory Committee said the data failed to prove enough evidence that the gel is safe and effective; it recommended against approval (9/10) |
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| CARDIOVASCULAR |
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| Actelion | Tracleer | Bosentan; endothelin receptor antagonist | Pulmonary arterial hypertension | FDA issued an approvable letter for Tracleer (9/18) |
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| Avant Immuno- | TP10 | Complement inhibitor | Infants undergoing cardiac surgery | FDA removed the hold on clinical trials; company expects to resume enrollment (9/28) |
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| Genentech | Cathflo | Activates plasminogen, which dissolves the blood-clotting material or fibrin to break down the thrombus and restore flow through the central venous catheter | To break down clots in central venous catheters | FDA approved the agent (9/5) |
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| Vasogen | ? | Immune modulation therapy | Peripheral arterial disease | FDA granted approval for the company to begin a pivotal clinical trial (9/5) |
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| CENTRAL NERVOUS SYSTEM | ||||
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| Repligen | Secretin | Human synthetic secretin | Pediatric autism | FDA granted fast-track designation for secretin (9/5) |
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DIABETES | ||||
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| Keryx Biopharm- | KRX-101 | Sulodexide | Diabetic nephropathy | FDA designated the compound a fast-track product (9/6) |
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INFECTION | ||||
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| Aviron | FluMist | Intranasal vaccine | Influenza | FDA issued a complete response letter related to the BLA, requiring additional information and clarification regarding clinical and manufacturing data (9/4) |
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| Cangene | ? | Hyperimmune product | Hepatitis B | Company filed a BLA (9/25) |
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| Visible | TruGene HIV-1 Genotyping Kit and Open- Gene DNA Sequencing System | Designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations and indicate a treatment regimen | AIDS | FDA gave the company clearance to market the three-part kit (9/27) |
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MISCELLANEOUS |
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| Amgen | Aranesp | Darbepoetin alfa; recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells | Anemia associated with chronic renal failure | FDA granted approval (9/18) |
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| Immunex | Enbrel | Tumor necrosis factor- inhibiting drug | Psoriatic arthritis | FDA granted priority review status for the supplemental BLA (9/17) |
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| Ortec Inter- | OrCel | Bilayered cellular matrix | Donor site wounds in burn victims | FDA aproved the product (9/4) |
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| PhotoCure | Metvix | Photodynamic therapy involving a cream that is activated by light | Actinic keratosis | Company submitted an NDA for Metvix in combination with the CureLight lamp in photodynamic therapy (9/27) |
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| Protherics | DigiFab | Consists of ovine antibody fragments that bind digoxin, preventing it from reaching the heart | Digoxin toxicity | FDA approved the product (9/4) |
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| 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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OSE = Oslo Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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| BLA = Biologics License Application; NDA = New Drug Application |
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