Company* |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha |
Fistulizing Crohn's disease |
FDA approved Remicade for reducing the number of draining enterocutaneous and recto-vaginal fistulas and for maintaining fistula closure (4/3) |
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CANCER | ||||
Celgene Corp. (CELG) |
Revimid |
A small-molecule compound that modulates the immune system |
Myelodysplastic syndromes |
Revimid received fast-track designation from the FDA (4/15) |
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Celmed BioSciences Inc. (subsidiary of Theratechnologies Inc.; Canada; TSE:TH) |
Theralux |
A photodynamic therapy being developed to destroy cancer cells in bone marrow or blood ex vivo using Th9402 |
Chronic myeloid leukemia |
FDA granted orphan drug status to Theralux (4/28) |
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Genta Inc. |
Ganite |
Gallium nitrate injection |
Cancer-related hypercalcemia |
Company filed its completed supplemental NDA (4/1) |
|
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NeoRx Corp. |
Targeted Skeletal Radiotherapy |
Designed to deliver high doses of radiation to tumor sites throughout the skeleton with minimal damage to organs outside the bone, targeting bone and adjacent marrow with a small-molecule agent, DOTMP, combined with the radionuclide holmium-166 |
Myeloma |
FDA lifted a clinical hold, and the company is considering starting a new Phase III trial (4/24) |
|
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CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. (ALKS) |
Risperdal Consta |
Long-acting injectable form of risperidone developed using Alkermes' Medisorb drug delivery technology |
Schizophrenia |
Company submitted a response to the FDA's non-approvable letler issued in June 2002 (4/29) |
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Sepracor Inc. (SEPR) |
Estorra |
Eszopiclone 2-mg and 3-mg tablets |
Transient and chronic insomnia |
FDA accepted the NDA (4/2) |
|
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INFECTION | ||||
GeneSoft Pharmaceuticals Inc.* |
Factive |
Gemifloxacin; a fluoroquinolone antibotic |
Community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis |
FDA approved Factive (4/7) |
|
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Vicuron Pharmaceuticals Inc. (MICU) |
Anidulafungin |
Antifungal agent |
Esophageal candidiasis |
Company filed an NDA (4/28) |
|
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MISCELLANEOUS | ||||
Genzyme General (GENZ) |
Fabrazyme |
Enzyme replacement therapy |
Fabry's disease |
FDA granted approval (4/24) |
|
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Genzyme General (GENZ) and BioMarin Pharmaceutical Inc. (BMRN) |
Aldurazyme |
Enzyme replacement therapy; laronidase |
Mucopolysacch-aridosis-1 |
FDA granted approval (4/30) |
|
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Indevus Pharmaceuticals Inc. (IDEV) |
Trospium |
Trospium chloride; a muscarinic receptor antagonist |
Overactive bladder |
Company filed an NDA (4/28) |
|
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ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Hyaluronidase for intravitreal injection |
Vitreous hemorrhage |
FDA issued an approvable letter, but may require a confirmatory study (4/7) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
TSE = Toronto Stock Exchange | ||||
