| Company* | Product | Description | Indication | Status (Date) |
| | ||||
CANCER | ||||
| Antigenics | Oncophage | Cancer vaccine | Renal cell carcinoma | FDA designated Oncophage a fast-track product (10/15) |
| AVAX | M-Vax and O-Vax | Autologous cancer vaccines | Cancer | FDA recommended AVAX prepare and submit new IND applications in regard to the FDA's clinical hold on the vaccines (10/25) |
| Celgene Corp. (CELG) | Revimid | Immunomodulatory drug | Myeloma | FDA granted orphan drug designation (10/8) |
| Cell Path- | Aptosyn and Taxotere | Exisulind and weekly docetaxel | Non-small-cell lung cancer | Phase III enrollment is suspended while a Data and Safety Monitoring Board reviews the data and reports it to the FDA in November (10/5) |
| Peregrine | Cotara | Tumor necrosis therapy drug; radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out | Recurrent glioblastoma multiforme | FDA granted fast-track status (10/10) |
| PrimeCyte | PC4071 | Identified by PrimeCyte's differential bioassay screening system, Cytection; selectively attacks soft tissue sarcomas and ovarian tumors | Soft tissue sarcomas | Company received orphan drug designation from the FDA (10/29) |
|
| ||||
| CENTRAL NERVOUS SYSTEM |
||||
| Serono SA | Rebif | A recombinant form of interferon beta-1a | Relapsing-remitting multiple sclerosis | Company submitted a supplemental BLA (10/8) |
|
| ||||
| DIABETES |
||||
| Advanced | Dermagraft | Bioengineered, cryopreserved tissue that stimulates foot ulcers to heal | Diabetic foot ulcers | FDA approved Dermagraft (10/1) |
| Amylin Pharmaceu- | Symlin | Analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas | Type I and Type II diabetes | FDA issued an approvable letter, but called for some additional tests before clearing it for marketing (10/12) |
|
| ||||
| INFECTION | ||||
| Gilead Sciences | Viread | Tenofovir disoproxil fumarate | HIV | FDA Antiviral Drugs Advisory Committee was split on the drug with nine members supporting a restricted label and seven members supporting a broad use (10/3); FDA approved the drug for all patients with the virus (10/29) |
| VaxGen Inc. | AIDSVAX | Vaccine; made from a synthetic protein | AIDS | A Data Safety Monitoring Board found the vaccine continues to exhibit an excellent safety profile and recommended that the Phase III study continue until its planned conclusion at the end of 2002 (10/30) |
| ViroPharma | Picovir | Oral antiviral product that inhibits the function of the picornavirus capsid | Viral respiratory infection | FDA accepted the NDA (10/1) |
|
| ||||
| MISCELLANEOUS | ||||
| Biogen Inc. | Amevive | Alefacept; novel immuno- modulatory agent that selectively targets the CD45RO+ subset of T cells | Psoriasis | FDA and European Agency for the Evaluation of Medicinal Products completed their initial reviews of the company's license application, and accepted it for filing (10/5) |
| Curis Inc. | OP-1 | An osteogenic protein | Long-bone nonunions | FDA approved OP-1, granting it device exemption status (10/18) |
| Genentech | Xanelim | Efalizumab | Moderate to severe psoriasis | Companies are delaying regulatory filing due to an FDA request for an additional study (10/5) |
| Genzyme | Fabrazyme | Agalsidase beta enzyme replacement therapy | Fabry's disease | FDA requested more data for the company's BLA through its second complete response data (10/22) |
| Gliatech | Adcon-L | Gel to inhibit postsurgical scarring | Lumbar surgeries | A reread of magnetic resonance imaging data from a U.S. pivotal trial found no significant difference in the maximum scar scores between the treatment group and the untreated control group; the results bar Adcon-L from reentering the U.S. market on guidelines previously laid out by the FDA (10/15) |
| Orphan | Xyrem | Oral solution; sodium oxybate | Cataplexy associated with narcolepsy | Company submitted an NDA amendment responding to the FDA's approvable letter in July (10/9); FDA accepted the response (10/23) |
| SkyePharma | UroXatral | Once-daily formulation of alfuzosin | Benign prostatic hyperplasia | Companies received an approvable letter from the FDA (10/10) |
| |
||||
| Notes: |
||||
| * Privately held |
||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
||||
| LSE = London Stock Exchange; NYSE = New York Stock Exchange |
||||
| BLA = Biologics License Application; NDA = New Drug Application; IND = Investigational New Drug |
||||
