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Company** | Product | Description | Indication | Type Action/Date |
Name | ||||
CANCER | ||||
DepoTech Corp. | DepoCyt | Injectable, sustained- | Neoplastic meningitis | FDA notified company |
and Chiron Corp. | release formulation of | arising from lympho- | that it may submit an | |
chemotherapeutic agent | mas (not from solid | NDA for the lymphoma | ||
cytarabine (uses Depo- | (tumors) | indication (8/31) | ||
Foam lipid-based drug | ||||
delivery) | ||||
Immunex Corp. | Paclitaxel | Generic paclitaxel; | 2nd-line therapy for | FDA confirmed that |
and Ivax Corp. | Injection | inhibits cancer cell | metastatic breast and | Immunex's ANDA (sub- |
(AMEX:IVX) | division by blocking | ovarian cancer | mitted 8/97; accepted | |
microtubule assembly/ | for review 10/97) is the | |||
disassembly; extracted | 1st filed ANDA for pacli- | |||
from all parts of 5-to-7- | taxel (8/13) | |||
year-old cultivars of | ||||
Pacific yew trees | ||||
Nexell Therapeu- | Isolex 300 | Stem cell selection | To support enrichment | Submitted all informa- |
tics Inc. (majority- | and | systems; devices that | of CD34+ cells and | in support of PMA appli- |
owned subsidiary | Isolex 300i | separate CD34+ stem | reduction of non-target | cation requested by FDA |
of Vimrx Pharma- | cells from peripheral | cells (including tumor | (8/31) | |
ceuticals Inc.) | blood (Isolex 300 is | cells) in autologous | ||
semi-automated; Isolex | transplants in breast | |||
300i is fully automated) | cancer, non-Hodgkin's | |||
lymphoma and other | ||||
B-cell malignancies | ||||
SuperGen Inc. | Paclitaxel | Generic paclitaxel | Cancer | Submitted ANDA (8/18) |
DIABETES | ||||
Advanced Tissue | Dermagraft | Human tissue-engi- | Wound healing in | FDA approved compan- |
Sciences Inc. and | neered replacement for | diabetic foot ulcers | ies' application for inves- | |
Smith & Nephew | dermal layer of skin | tigational device exemp- | ||
plc (U.K.) | (viable human dermal | tion for additional trial to | ||
fibroblasts, derived from | support PMA (8/5) | |||
foreskins, cultured on | ||||
bioresorbable scaffold) | ||||
Ergo Science | Ergoset | Low-dose, oral formu- | Type II diabetes (mono- | Submitted amendment |
Corp. | Tablets | lation of bromocriptine | therapy as adjunct to | to NDA (8/24) |
(ergot alkaloid; generic | diet to improve glycem- | |||
dopamine agonist) | ic control in diabetics) | |||
INFECTION | ||||
Aviron | FluMist | Nasal spray formu- | Prevention of influenza | FDA notified company |
lation of influenza | infection in children and | that its PLA/ELA was not | ||
vaccine; attenuated, | adults, as well as in high- | accepted for filing; FDA | ||
cold-adapted live | risk adults (when co- | requires additional infor- | ||
virus vaccine | administered with inact- | mation on manufact- | ||
ivated vaccine) | ing and process valida- | |||
tion (8/31) | ||||
Isis Pharma- | Vitravene | Fomivirsen; anti- | Newly diagnosed and | Approved for marketing |
ceuticals Inc. and | sense inhibitor of | advanced CMV retinitis | (8/27) | |
Ciba Vision Corp. | cytomegalovirus | in AIDS patients | ||
(unit of Novartis AG; | (CMV) replication | |||
Switzerland) | (intravitreal injection) | |||
Nabi | H-BIG | Reformulated hepatitis | Prevention of hepatitis | Submitted PLA and sup- |
B immune globulin | B virus infection | plement to ELA 8/17) | ||
(human) | ||||
Schering-Plough | Intron A | Recombinant human | Chronic hepatitis B | Approved for marketing |
Corp. (NYSE:SGP) | (FDA- | interferon alfa-2b; | virus infection in | (8/25) |
approved) | injection | children 1 year or older | ||
Schering-Plough | Rebetron | Combination of | Combination therapy | FDA accepted supple- |
Corp. (NYSE:SGP) | Intron A (recombi- | for treating chronic | mental NDA for filing | |
and ICN Pharma- | nant human interferon | hepatitis C virus | and granted it priority | |
ceuticals Inc. | alfa-2b; injection) and | infection in patients | review status (8/17) | |
(NYSE:ICN) | Rebotol (ribavirin; | with compensated liver | ||
synthetic nucleoside | disease who have not | |||
with antiviral activity; | received previous alpha- | |||
oral) | interferon therapy | |||
(treatment-naive) | ||||
SmithKline | Engerix-B | Recombinant hepatitis | Prevention of hepatitis | Approved for marketing |
Beecham plc | (FDA- | B vaccine | B virus infection in | (8/13) |
(NYSE:SBH; U.K.) | approved) | patients with chronic | ||
hepatitis C virus | ||||
infection | ||||
MISCELLANEOUS | ||||
Centocor Inc. | Remicade | Infliximab; chimeric | Moderate-to-severe | Approved for marketing |
(formerly | monoclonal antibody to | Crohn's disease in | (8/24) | |
Avakine) | tumor necrosis factor- | patients for whom con- | ||
alpha | ventional therapy is | |||
inadequate; also for | ||||
fistulizing Crohn's | ||||
disease | ||||
Metra | Pyrilinks-D | Urine-based assay that | Test to monitor patient | Cleared for marketing |
Biosystems Inc. | (FDA- | measures excretion of | response to hormone | (8/17) |
approved) | deoxypyridinoline cross- | replacement therapy in | ||
links (immunoassay; | treatment and prevention | |||
biochemical indicator | of osteoporosis | |||
of bone resorption) | ||||
Noven Pharma- | CombiPatch | Transdermal patch con- | Relief of moderate-to- | Approved for marketing |
ceuticals Inc. | taining estradiol and | severe vasomotor sym- | (8/10) | |
norethindone acetate | ptoms in menopausal | |||
(estrogen/progestogen) | women (hormone re- | |||
placement therapy) | ||||
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. 11-12. |