Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Biogen Inc. (BGEN) |
Amevive |
Alefacept; novel immuno-modulatory agent that selectively targets the CD45RO+ subset of T cells |
Psoriasis |
The Dermatologic and Ophthalmic Ophthalmic Drugs Advisory Committee recommended approval of Amevive (5/23) |
CANCER | ||||
Antigenics Inc. (AGEN) |
Oncophage |
Vaccine; uses heat shock proteins to activate cellular immune responses |
Renal cell carcinoma |
FDA granted orphan drug status for Oncophage (5/29) |
CancerVax Corp.* |
Canvaxin |
Allogeneic; whole-cell vaccine that expresses over 20 antigens |
Cancer |
FDA asked the company to provice certain information related to the production, characterization and testing of Canvaxin; it has placed a hold on the Phase III trial (5/2) |
Corixa Corp. (CRXA) |
Bexxar |
A radioimmunotherapy; tositumomab, iodine-131 |
Non-Hodgkin's lymphoma |
Company is requesting an appeal of the FDA's complete review letter that said additional clinical studies are necessary to win marketing approval (5/15); Corixa filed a request for formal dispute of resolution and also requested the opportunity to present Bexxar safety and efficacy data to the Oncologic Drugs Advisory Committee (5/31) |
Genentech Inc. (NYSE:DNA) |
Tarceva |
Small-molecule epidermal growth factor receptor inhibitor |
Non-small-cell lung cancer |
FDA designated Tarceva a fast-track product (5/14) |
Ilex Oncology Inc. (ILXO) |
Campath (FDA-approved) |
Alemtuzumab; humanized monoclonal antibody |
Cancer |
Company filed a supplemental BLA based on two-year follow-up data in patients who have been treated with alkylating agents and failed fludarabine (5/21) |
ImClone Systems Inc. (IMCL) |
Erbitux |
Cetuximab; designed to target and block the epidermal growth factor receptor |
Cancer |
Company plans to run several more trials in the U.S. to satisfy the FDA's questions in order to seek approval (5/22) |
MediGene AG (Germany; Neuer Markt:MDG) |
G207 |
Modified herpes simplex virus that has been genet ically engineered to selectively multiply in tumor cells and cause cancer cell death without harm to healthy tissue |
Malignant glioma |
FDA granted orphan drug designation to G207 (5/8) |
NaPro Biotherapeutics Inc. (NPRO) and Abbott Laboratories Inc. |
Paclitaxel injection |
Metastatic cancer of the ovary and metastatic breast cancer |
Companies received approval from the FDA to market paclitaxel injection (5/9) |
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NeoPharm Inc. (NEOL) |
IL13-PE38 |
Tumor-targeting product |
Malignant glioma |
FDA granted fast-track designation to the product (5/6) |
SuperGen Inc. (SUPG) |
MitoExtra |
Mitomycin; designed to produce a stable, ready-to-inject anticancer solution with commercially attractive shelf life at room temperature |
Cancer |
FDA accepted as complete the company's amendment to its NDA (5/23) |
CARDIOVASCULAR | ||||
United Therapeutics Corp. (UTHR) |
Remodulin |
Treprostinil sodium; subcutaneous treatment |
Pulmonary arterial hypertension |
FDA approved Remodulin (5/23) |
CENTRAL NERVOUS SYSTEM | ||||
Orphan Medical Inc. (ORPH) |
Xyrem |
Sodium oxybate oral solution |
Cataplexy associated with narcolepsy |
Company submitted a complete response to the FDA to address issues raised in an approvable letter received from the agency April 9 (5/17); FDA accepted the complete response (5/23) |
Penwest Pharmaceuticals Co. (PPCO) |
Lexapro |
A prescription drug formulated with Penwest's Prosolv; a single-isomer selective serotonin reuptake inhibitor; escitalopram |
Major depressive disorder |
FDA issued an approvable letter (5/29) |
INFECTION | ||||
Berna Biotech Ltd.* (Switzerland) |
Aerugen |
Vaccine |
Pseudomonas aeruginosa infection |
Company received orphan status in the U.S. for its Aerugen vaccine (5/22**) |
ViroPharma Inc. (VPHM) and Aventis Pharmaceuticals |
Picovir |
Works by inhibiting the ongoing viral replication of picornavirus capsid, a protective shell of the virus that is necessary for infection and transmission |
Common cold |
Company said the FDA intends to issue a not-approvable letter for the NDA (5/10) |
MISCELLANEOUS | ||||
Repligen Corp. (RGEN) |
SecreFlo (FDA-approved) |
A synthetic porcine secretin |
Pancreas divisum |
Company filed a supplemental NDA to support the use of SecreFlo to aid in the location and cannulation of the minor pancreatic duct in patients with pancreas divisum undergoing endoscopic retrograde chol-angiopancreatography (5/28) |
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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. | ||||
NYSE = New York Stock Exchange | ||||
