Company* |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Biogen Inc. |
Avonex |
Interferon beta-1a |
Multiple |
FDA granted Biogen a new label indication for Avonex, allowing it to be prescribed for treatment of patients after the first MS attack, if a brain scan shows abnormalities typical of the disease (2/7) |
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XOMA Ltd. |
Raptiva |
Efalizumab; a recombinant humanized monoclonal antibody |
Plaque psoriasis |
FDA accepted the BLA (2/28) |
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CANCER | ||||
Aesgen Inc.* |
Aesgen-14 (AES-14) |
Mouth rinse suspension that is used two or three times per day during chemotherapy |
Oral mucositis associated with cancer chemotherapy |
FDA granted fast-track designation (2/3) |
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Aphton Corp. (APHT) |
G17DT |
Anti-gastrin immunogen |
Gastric cancer |
FDA granted fast-track designation for G17DT immunogen in combination with cisplatin and 5-FU for use in Stage IV gastric cancer to improve overall survival (2/21) |
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Atrix |
Eligard |
Leuprolide acetate for injectable suspension |
Advanced |
FDA approved Eligard 30 mg for the palliative treatment of advanced prostate cancer (2/18) |
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Celgene Corp. |
Revimid |
A small-molecule compound that modulates the immune system |
Multiple |
FDA granted fast-track designation (2/4) |
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Guilford |
Gliadel Wafer (FDA-approved) |
Wafer comprised of a biodegradable polymer incorporating 7.7mg of carmustine |
Malignant glioma |
FDA granted approval to expand the use of the Gliadel Wafer as a first-line therapy for patients with high-grade malignant glioma (2/26) |
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Introgen |
Advexin |
Adenoviral p53 product |
Head and neck |
FDA granted orphan drug designation for Advexin (2/20) |
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PhotoCure ASA |
Metvix PDT |
Photodynamic therapy; a cream that is absorbed into the cancer cells, followed by activation of the drug through illumination with a red light source called Curelight |
Basal cell carcinoma |
Company submitted an NDA to treat nodular and superficial basal cell carcinoma (2/26**) |
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Praecis |
Plenaxis |
Abarelix for injectable suspension |
Prostate cancer |
Company resubmitted to the FDA its NDA for Plenaxis (2/26) |
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SuperGen Inc. |
Orathecin |
Oral chemotherapy |
Pancreatic cancer |
Company submitted the second of three parts for the NDA for Orathecin (2/7) |
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CARDIOVASCULAR | ||||
Dyax Corp. (DYAX) |
DX-88 |
Recombinant inhibitor of human plasma kallikrein |
Angioedema |
FDA granted orphan drug designation to DX-88 (2/12) |
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CENTRAL NERVOUS SYSTEM | ||||
Endo Pharmaceuticals Inc. (ENDP) |
Oxymorphone |
Extended-release and immediate-release tablets; opioid analgesic |
Pain |
FDA accepted the NDAs for Oxymorphone ER and IR (2/19) |
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Sepracor Inc. (SEPR) |
Estorra |
Eszopiclone 2-mg and 3-mg tablets |
Transient and chronic insomnia |
Company submitted an NDA (2/3) |
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INFECTION | ||||
Cubist Pharmaceuticals Inc. (CBST) |
Cidecin |
Daptomycin for injection |
Skin and skin structure infections caused by Gram-positive organisms |
FDA accepted the NDA (2/20) |
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MedImmune Inc. (MEDI) |
FluMist |
Influenza vaccine delivered as a nasal mist |
Influenza |
Company submitted information requested by anFDA complete response letter (2/7) |
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MISCELLANEOUS | ||||
Galen |
Ovcon |
Oral contraceptive |
To prevent conception |
Company received an approvable letter from the FDA (2/5) |
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NexMed Inc. |
Alprox-TD |
Cream; incorporates alprostadil with the company's Nex ACT transdermal delivery technology |
Erectile dysfunction |
FDA lifted its partial clinical hold on Alprox-TD; the hold was made due to the company's 26-week dermal carcinogenicity study in transgenic mice (2/27) |
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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. | ||||
OSE = Oslo Stock Exchange | ||||
