Company* | Product | Description | Indication | Status |
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CANCER |
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EntreMed | Endostatin | A protein drug candidate | Neuroendocrine tumors | Endostatin received orphan drug status from the FDA (8/15) |
EntreMed | Panzem | An orally available small-molecule drug candidate | Multiple myeloma | Panzem received orphan drug status from the FDA (8/15) |
Inex | Onco TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Non-Hodgkin's lymphoma | An independent data safety monitoring board reviewed safety data for about 35 patients in the pivotal Phase II/III trial and recommended that Inex continue the trial (8/13) |
KS Biomedix | TransMID- | Based on the transferrin- mediated delivery of a diphtheria toxin, which is capable of selectively killing cancer cells | Glioma | FDA granted the product fast-track status (8/6) |
Vysis Inc. | UroVysion | Test for monitoring recurrence of bladder cancer, which is based on the detection of genetic changes in bladder cells using the company's fluorescence DNA probe technology | Bladder cancer | FDA gave clearance to market the test (8/2) |
CARDIOVASCULAR |
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Actelion Ltd. | Tracleer | Bosentan; endothelin receptor antagonist | Pulmonary arterial hypertension | The Cardiovascular and Renal Drugs Advisory Committee recommended approval (8/10) |
Hemosol Inc. | Hemolink | A red-blood cell substitute; a purified, human-derived hemoglobin replacement product | Patients undergoing coronary artery bypass surgery | The FDA asked for changes in the Phase III trial protocol, delaying the trial; the changes are related to the dosing schedule of the product (8/13) |
Scios Inc. | Natrecor | Nesiritide; intravenous treatment; recombinant of B-type natriuretic peptide | Acute congestive heart failure | FDA granted marketing approval (8/13) |
United | Remodulin (formerly UT-15 and Uniprost) | Subcutaneous treatment; treprostinol sodium | Pulmonary arterial hypertension | The Cardiovascular and Renal Drugs Advisory Committee recommended approval (8/9) |
CENTRAL NERVOUS SYSTEM | ||||
Amgen Inc. | Kineret | Anakinra; interleukin-1 receptor antagonist | Rheumatoid arthritis | The FDA's Arthritis Advisory Committee recommended approval of Kineret in patients 18 and older (8/16) |
INFECTION | ||||
Enzon Inc. | Peg-Intron Powder | Injection; longer-acting form of Intron A Injection that uses Enzon's PEG technology | Chronic hepatitis C in patients with compensated liver disease | FDA approved Peg-Intron Powder used in combination therapy with Rebetol Capsules (8/8) |
Gilead | Viread | Tenofovir disoproxil fumarate | HIV infection | The Antiviral Advisory Committee of the FDA will review the treatment on Oct. 3 (8/22) |
MISCELLANEOUS | ||||
Biogen Inc. | Amevive | Novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells | Chronic plaque psoriasis | Company completed registration filings in the U.S. and Europe seeking approval to market Amevive (8/6) |
Celgene Corp. | Dexmethyl- | A refined formulation of Ritalin (dl-methylphenidate) | Attention deficit hyperactivity disorder | FDA provided the companies with an approvable letter (8/22) |
Northfield | PolyHeme | Alternative to blood transfusions for patients with acute blood loss; carries oxygen, restores blood volume and is designed to treat hemorrhagic shock resulting from extensive bloodletting | To treat life-threatening blood loss | Company submitted a BLA (8/28) |
Orphan | Xyrem | Sodium oxybate oral solution | Narcolepsy | Company said the FDA accepted its plan for a response to the FDA's approvable letter dated July 2 (8/28) |
Oxford Glyco- | Vevesca | Oral treatment; capsule formulation of a glucosyl-transferase inhibitor | Type I Gaucher disease | Company filed an NDA (8/21) |
QLT Inc. | Visudyne | Verteporfin for injection | Class subfoveal choroidal neo- vascularization | FDA grants additional approval to market the product in people age 30 and older (8/23) |
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Notes: | ||||
* Privately held; ** Denotes the date the item ran in BioWorld International | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application |