Company** |
Product |
Description |
Indication | Type Action (Date) |
CANCER | ||||
Nexell Therapeutics Inc.majority-owned subsidiary of Vimrx Pharmaceuticals Inc.) |
Isolex 300 and Isolex 300i |
Stem cell selection systems; devices that separate CD34+ stem cells from peripheral blood (Isolex 300 is semi-automated; Isolex 300i is fully automated) |
To support enrichment of CD34+ cells and reduction of non-target cells (including tumor cells) in autologous transplants in B-cell malignancies | FDA sent company an approvable letter (1/8) |
U.S. Bioscience Inc. and Alza Corp. | Ethyol (FDA-approved) |
Amifostine; selective cytoprotective agent |
To reduce incidence and severity of radiation-induced xerostomia (dry mouth) in patients with head and neck cancer | Submitted supplemental NDA (1/7) |
CARDIOVASCULAR | ||||
Scios Inc. and Bayer AG (Germany) | Natrecor | Nesiritide; human B-type natriuretic peptide (BNP; naturally occurring hormone produced in the heart) | Short-term management of congestive heart failure |
FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval (5 to 3 vote) (1/29) |
CENTRAL NERVOUS SYSTEM | ||||
Chiroscience Group plc (U.K.) | Chirocaine | Levobupivacaine; chiral version of approved drug bupivacaine | Broad usage in local, regional or spinal anesthesia |
FDA's Anesthetics and Life Support Drugs Advisory Committee voted unanimously to recommend approval (1/12) |
Elan Corp. plc (Ireland) | NeuroBloc |
Botulinum toxin type B |
Cervical dystonia (inhibits transmission of acetylcholine); intra-muscluar injection | Submitted PLA (1/11) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. | AC2993 |
Exendin-4; synthetic version of protein originally isolated from saliva of Gila monster (39 amino acid peptide; has 50% structural homology with human hormone glucagon like peptide-1) |
Type II diabetes |
Filed IND (1/13) |
Cygnus Inc. | GlucoWatch device; uses reverse iontophoresis to non-invasively extract and measure glucose levels | Glucose monitoring fluctuating glucose levels in diabetics |
To aid in controlling | Submitted 1st part of PMA (1/25) |
INFECTION | ||||
Cubist Pharmaceuticals Inc. |
Daptomycin | Lipopeptide antibiotic (intravenous) |
Life-threatening infections caused by Grampositive bacteria (including bacteremia and complicated skin and soft-tissue infections) |
Filed IND for open-label Phase II trial (bacteremia) and for Phase III trial (skin and soft-tissue infections) (1/5) |
Shaman Pharmaceuticals Inc. (OTC Bulletin Board: SHMN) | Provir | Oral formulation of compound SP-303, which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells |
AIDS-related diarrhea |
Held pre-NDA meeting with FDA, after which the company said it is reviewing its filing strategy (could include labeling change and more trials) (1/27) |
MISCELLANEOUS | ||||
Centocor Inc. |
Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Rheumatoid arthritis | Submitted supplemental BLA (1/26) |
Cypress Bioscience Inc. | Prosorba Column (FDA-approved) |
Disposable filter that uses Protein A to remove circulating immune complexes from patient's blood |
Moderate to severe rheumatoid arthritis in patients who have failed 2nd-line therapy |
FDA issued letter of deficiency related to ongoing product review; FDA requested additional information, including documentation from pivotal trial (1/25) |
NOTES: | ||||
Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products. | ||||
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 14-15. | ||||
