Company* (Symbol) | Product | Description | Indication | Status (Date) |
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CANCER |
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Atrix Laboratories Inc. (ATRX) | Leuprogel | Leuprolide acetate for subcutaneous depot for injection; leuprolide is a luteinizing hormone-releasing hormone agonist | Advanced prostate cancer | Company closed enrollment for a Phase III trial (3/23); company submitted an NDA (3/27) |
AVAX Technologies Inc. (AVXT) | M-Vax and O-Vax | Autologous cancer vaccines | Cancer | FDA placed M-Vax and O-Vax trials on clinical hold (3/23) |
Corixa Corp. (CRXA) | Bexxar | Radioimmunotherapy antibody conjugated to iodine-131 | Non-Hodgkin's lymphoma | FDA asked for more safety and efficacy data for the company's BLA for Bexxar (3/19) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin | Capsules; bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors | Advanced non-small-cell lung cancer | Company initiated a registration program, following its meeting with the FDA in December; program is designed to support a supplemental indication for Targretin capsules (3/20) |
Lorus Therapeutics Inc. (Canada; LORFF; TSE:LOR) | GTI-2501 | Antisense compound | Cancer | FDA gave clearance to begin a Phase I trial (3/19) |
Matrix Pharmaceuticals Inc. (MATX) | IntraDose Injectable Gel | Cisplatin/epinephrine | Refractory or recurrent head and neck cancer | FDA accepted the NDA for filing (3/7) |
MediGene Inc. (unit of MediGene AG; Germany; Neuer Markt:MDG) | G207 | Anticancer therapeutic; modified herpes simplex virus genetically engineered to replicate in and kill cancer cells while sparing normal cells | Brain tumors | Company submitted to the FDA a final study report of its Phase I trial (3/14**) |
Neoprobe Corp. (OTC BB:NEOP) | Radiolabeled agent | Agent is designed to assist in the diagnosis and surgical management of breast cancer patients | Breast cancer | FDA gave clearance for researchers to begin clinical evaluation of the agent (3/7) |
Novartis Oncology (unit of Novartis AG; Switzerland; NYSE:NVS) | Glivec (formerly STI571) | A new type of antiproliferative agent called a signal transduction inhibitor; targets an abnormal protein produced by the Philadelphia chromosome | Chronic myeloid leukemia | Company submitted applications in the U.S. and Europe for marketing authorization (3/1) |
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CARDIOVASCULAR |
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Avant Immuno-therapeutics Inc. (AVAN) | TP10 | Soluble form of complement inhibitor receptor 1, designed to inhibit complement proteins | Infants undergoing high-risk cardiac surgery | Company said it is making protocol changes to the Phase IIb trial after discussions with the FDA, delaying the trials (3/12) |
Corgentech Inc.* | E2F Decoy | An oligonucleotide designed to prevent vein grafts from blocking and failing | Coronary artery and peripheral arterial bypass | FDA granted fast-track designation for the product (3/20) |
Immunex Corp. (IMNX) | Enbrel (FDA-approved) | Tumor necrosis factor receptor | Chronic heart failure | Company stopped Phase II/III trials when an independent data monitoring board told the company it is unlikely Enbrel will meet the efficacy endpoints (3/22) |
InKine Pharmaceutical Co. Inc. (INKP) | Hematrol | CBP-1011; tablet formulation of orally available steroid | Thrombocytopenic purpura | FDA designated Hematrol an orphan drug (3/5) |
NitroMed Inc.* | BiDil | Combination drug containing isosorbide dinitrate and hydralazine hydrochloride | African American heart failure | Company received a letter from the FDA requesting a confirmatory study (3/8) |
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CENTRAL NERVOUS SYSTEM |
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Celltech Group plc (UK; NYSE:CLL) | Metadate CD | Extended-release capsules; methylphenidate HCl | Attention deficit hyperactivity disorder | Company received an approvable letter from the FDA (3/16) |
Orphan Medical Inc. (ORPH) | Xyrem | Oral solution; sodium oxybate | Narcolepsy | FDA advisory committee cancelled its review of the NDA for Xyrem due to questions surrounding some data (3/2); FDA extended its priority review of the NDA allowing the submission of additional data (3/30) |
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INFECTION |
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Chiron Corp. (CHIR) and Gen-Probe Inc.* | Procleix HIV1/HCV assay | Nucleic acid amplification test designed to detect the presence of HIV and HCV in whole blood and plasma in the earliest stages of infection |
HIV-1 and hepatitis C virus | FDA accepted for review the BLA (3/12) |
Enzon Inc. (ENZN) and Schering-Plough Corp. | Peg-Intron | Powder for injection; a longer-acting form of Schering's Intron A that uses PEG technology | Chronic hepatitis C | FDA granted priority review status for the supplemental BLA to use the powder in combination with Rebetol capsules (3/23) |
Stressgen Biotechnologies Corp. (Canada; TSE:SSB) | HspE7 | Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium-bovis BCG and the protein E7 | Human papilloma-virus-related disease, or recurrent respiratory papillomatosis | FDA granted orphan drug status to HspE7 (3/29) |
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MISCELLANEOUS |
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CeNeS Pharmaceuticals plc (UK; LSE:CEN) | CEE 03-310 | Dopamine antagonist | Alcohol abuse | Company gained U.S. approval to carry out a Phase II trial (3/14**) |
Ortec International Inc. (ORTC) | Composite cultured skin | Cryopreserved (frozen) version of CCS | Burns | Company filed a premarket approval application with the FDA, requesting permission to market its composite cultured skin to treat split-thickness donor sites in burn patients (3/7) |
RxKinetix Inc.* and Elan Corp. plc (Ireland) | RK-0202 | Developed using RxKinetix's ProGelz polymer drug delivery system | Oral mucositis | FDA reviewed the IND without comment, allowing the start of a Phase Ib trial (3/7) |
Sepracor Inc. (SEPR) | Soltara | Norastemizole 30 mg capsules | Allergic rhinitis | Company submitted an NDA (3/12) |
Serono SA (Switzerland; NYSE:SRA) | Gonal-F | Follitropin alfa for injection | Infertility | FDA granted marketing authorization for multidose Gonal-F (3/6) |
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Notes: |
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* Privately held ** Denotes the date the item ran in BioWorld International. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange |
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BLA = Biologics License Application; IND = Investigational New Drug application; NDA = New Drug Application |
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