Company* | Product | Description | Indication | Status (Date) |
AUTOIMMUNE |
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Amgen Inc. | Enbrel | Etanercept; tumor | Psoriatic arthritis and rheumatoid arthritis | Company submitted a supplemental BLA to the FDA supporting once-weekly dosing of Enbrel (12/23) |
Cambridge Antibody | Humira | Adalimumab; an anti- | Rheumatoid arthritis | FDA approved Humira (12/31) |
Connetics Corp. | OLUX Foam | Clobetasol propionate; | Psoriasis | FDA approved the company's supplemental NDA to expand the label for OLUX to include the short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertrigi- nous areas (12/23) |
Genentech Inc. | Raptiva | Efalizumab; | Psoriasis | Companies submitted a BLA (12/23) |
CANCER |
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Alfacell Corp. | Onconase | Cytotoxic ribonuclease; | Malignant mesothelioma | FDA gave the product fast-track designation (12/19) |
Axcan Pharma Inc. | Photofrin (FDA- | Photodynamic therapy | High-grade | FDA granted an approvable letter, but is requesting further clinical information (12/2) |
Corixa Corp. | Bexxar | Tositumomab and | Lymphoma | FDA accepted additional data as well as responses to concerns raised about the BLA (12/3); FDA panel recommended approval (12/17) |
SuperGen Inc. | Orathecin | Rubitecan; oral | Pancreatic | Company began a rolling submission of an NDA (12/30) |
CARDIOVASCULAR |
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CV Therapeutics | Ranexa | Ranolazine; part of | Chronic | Company submitted an NDA (12/30) |
ISTA | Vitrase | Injectable enzyme; | Vitreous hemorrhage | FDA accepted the NDA for filing (12/17) |
CENTRAL NERVOUS SYSTEM |
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Cephalon Inc. | Provigil | Modafinil tablets; | Narcolepsy, sleep apnea and shift-work sleep disorder | Cephalon filed a supplemental NDA seeking a broadened label that would include other sleep and wakefulness disorders (12/23) |
Endo | Oxy- | Opioid analgesic | Moderate | Company filed an NDA for both the immediate- and extended- release oxymorphone oral tablets (12/20) |
Forest Laboratories | Memantine | Orally available | Alzheimer's | Companies filed an NDA (12/20) |
Pozen Inc. | MT 300 | A formulation of | Migraine | Company submitted an NDA (12/17) |
INFECTION |
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Cubist | Cidecin | Daptomycin for | Complicated | Company submitted an NDA for injectable Cidecin (12/20) |
Inhibitex Inc.* | Veronate | Antibody-based | To prevent | FDA granted fast-track status for Veronate to prevent infections in very low-birth-weight infants (12/11) |
MedImmune | FluMist | Intranasal vaccine | Influenza | FDA panel recommended FluMist for approval in people ages 5 to 49 (12/17) |
Nabi | Civacir | Hepatitis C immune | Hepatitis C | FDA granted orphan drug status for Civacir (12/5) |
VaxGen Inc. | AIDSVAX | AIDS vaccines made | HIV | FDA designated the vaccine candidates fast-track products (12/16) |
Vertex | GW433908 | Protease inhibitor; | HIV | Companies filed for approval in the U.S. (12/20) |
MISCELLANEOUS |
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Genentech Inc. | Xolair | Omalizumab; anti-IgE | Allergic | Genentech finalized the BLA by submitting an amendment that includes safety data from an 1,899-patient trial and eliminating hay fever as the indication for moderate to severe allergic asthma in adult and adolescent patients (12/19) |
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Notes: |
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* Privately held. |
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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; NDA = New Drug Application |
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