Company* (Symbol) | Product | Description | Indication | Status (Date) |
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CANCER |
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Celgene Corp. (CELG) | Thalomid | Thalidomide; modulates levels of tumor necrosis factor-alpha | Multiple myeloma | FDA said the company has to conduct a new trial in a different indication; the company will now pursue seeking approval of Thalomid in early stage multiple myeloma, instead of refractory/relapsed multiple myeloma (3/7) |
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Corixa Corp. (CRXA) | Bexxar | Tositumomab, iodine-131; radioimmuno- | Non-Hodgkin's lymphoma | FDA said the company failed to provide sufficient evidence of safety and clinical benefit in its BLA (3/13) |
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Guilford Pharm- | Gliadel Wafer (FDA- | Biodegradable polyanhydride polymer wafer implant containing carmustine | Malignant glioma | FDA issued a non-approvable letter rejecting a supplemental NDA for use of the Gliadel Wafer in patients with newly diagnosed malignant glioma (3/20) |
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CENTRAL NERVOUS SYSTEM | ||||
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Serono SA | Rebif (FDA- | Interferon beta 1-a | Multiple sclerosis | FDA approved Rebif (3/8) |
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INFECTION | ||||
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Cubist Pharma- | Cidecin | Daptomycin for injection | Complicated skin and soft tissue infections | Company plans to submit an NDA before the year's end after FDA indicated it would be accepted for filing as proposed (3/7) |
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Gilead Sciences Inc. (GILD) | Adefovir dipivoxil | Nucleotide analogue that works by blocking the hepatitis B virus DNA polymerase | Hepatitis B | Company filed an NDA (3/22) |
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ViroPharma Inc. (VPHM) | Picovir | Pleconaril; oral antiviral product that inhibits the function of the picornavirus capsid | Viral respiratory infection | An FDA advisory committee recommended against approval (3/19) |
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MISCELLANEOUS | ||||
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Centocor Inc. (unit of Johnson and Johnson) | Remicade (FDA- | Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood | Crohn's disease | FDA granted priority review status for Remicade as a monotherapy for inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease (3/21) |
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Corus Pharma Inc.* | Corus 1020 of patients with cystic fibrosis | Inhalation therapy; antibiotic with activity against Gram-negative bacteria | Gram-negative bacteria in the respiratory tract | Corus 1020 was granted orphan drug designation by the FDA (3/20) |
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Elan Corp. plc (Ireland) and Ligand Pharmaceuticals Inc. (LGND) | Avinza (FDA- | Once-daily treatment; morphine sulfate extended-release | Chronic, moderate to severe pain | Companies received U.S. regulatory approval for Avinza (3/21) |
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InKine Pharmaceutical Co. Inc. (INKP) | Visicol (FDA- | Tablet form; sodium phosphate | Bowel cleansing prior to colonoscopy | FDA approved the supplemental NDA for a new formulation of Visicol tablets; the new, smaller Visicol tablet contains significantly less microcrystalline cellulose than the current formulation (3/14) |
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Orthologic Corp. (OLGC) | Chrysalin | Synthetically manufactured peptide | Spinal fusion | FDA gave the company authorization to begin a combined I/II trial of Chrysalin; the trial will include about 300 patients (3/8) |
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SangStat Medical Corp. (SANG) | Thymoglobulin (FDA- | Anti-thymocyte globulin, rabbit; organ rejection therapeutic | Kidney transplant rejections | An independent Data Safety and Monitoring Board decided to close the company's comparative kidney transplant study early after an interim analysis revealed significantly fewer acute rejections in patients treated with Thymoglobulin vs. Novartis AG's Simulect (3/12) |
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Sepracor Inc. (SEPR) | Soltara | Tecastemizole 15-mg and 30-mg capsules; active metabolite; nonsedating antihistamine; norastemizole | Allergic rhinitis | FDA said it will issue a not-approvable letter due to safety studies in animals that were not observed in humans, and other concerns (2/7) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
NYSE = New York Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
