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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.