Company (Symbol)* | Product | Description | Indication | Action/Date** |
CANCER | ||||
Cell Pathways Inc. (CLPA) | Aptosyn | Exisulind; cyclic GMP phosphodiesterase inhibitor | Familial adenomatous polyposis | FDA accepted the company's new drug application (NDA) (10/25) |
Genta Inc. (GNTA) | G-3139 | Bcl-2 antisense compound designed to reduce the Bcl-2 protein level in cancer through an antisense mechanism that specifically targets the messenger-RNA produced by the bc-2 gene | Malignant melanoma | Received fast-track designation (10/28) |
The Liposome Co. Inc. (LIPO) | Evacet | Liposomal formulation of doxorubicin | Metastatic breast cancer | Withdrew NDA following consultation with the FDA regarding issues raised by the Oncologic Drugs Advisory Committee (ODAC); the company expects to resubmit the NDA by the end of 1999 (1/14) |
Neurocrine Biosciences Inc. (NBIX) | NBI-3001 | IL-4 fusion toxin compound with high affinity for IL-4 receptors, which are localized on the surfaces of tumors, but not on normal cells | Malignant brain tumors | Received fast-track designation (10/14) |
Vical Inc. (VICL) | Allovectin-7 | Anticancer therapeutic that uses a lipid-DNA complex to help the immune system recognize and attack cancer cells | Invasive and metastatic melanoma | Received orphan drug designation (10/27) |
Vion Pharmaceuticals Inc. (VION) | VNP20009 | Tumor amplified protein expression therapy platform that uses genetically altered strains of Salmonella as a bacterial vector for delivering cancer-fighting drugs to solid tumors | Cancer patients with accessible solid tumors | Received approval to begin Phase I trials (10/11) |
CARDIOVASCULAR | ||||
Protherics plc (formed through the merger of Proteus International plc and Therapeutic Antibodies Inc.; UK) | DigiTAb | Antidote to digoxin poisoning | Digoxin toxicity | FDA accepted product license application and establishment license application (10/13) |
CENTRAL NERVOUS SYSTEM | ||||
NeuroSearch (Denmark)* | NS2330 | Therapeutic compound that increases the activity of acetylcholine, dopamine and noradrenaline | Alzheimer's disease | Received approval to commence Phase II trial (10/25) |
DIABETES | ||||
Ergo Science Corp. (ERGO) | Ergoset | Bromocriptine mesylate | Type 2 diabetes | Received approvable letter for NDA (10/21) |
Protein Delivery Inc.* | Oral formulation of insulin | Diabetes | FDA accepted investigational new drug application (IND) (10/19) | |
Ortec International Inc. (ORTC) | Composite cultured skin | Tissue-engineered dressing consisting of two layers of human-derived skin cells (dermal and epidermal) supported with a porous collagen matrix | Diabetic ulcers | Received approval to proceed with multi-center pilot clinical trial (10/27) |
INFECTION | ||||
CV Technologies (Canada; ASE:CVQ) | CVT-3002 | Multi-component phytopharmaceutical extracted from North American ginseng, thought to act as a prophylactic | Acute respiratory infection | Received approval to commence Phase II trials (10/7) |
Inhibitex Inc.* | SA-IGIV | Antibody-based product targeting antibiotic-resistant Staphylococcus aureus | End-stage renal disease | Received approval to commence Phase I/II trials (10/28) |
MISCELLANEOUS | ||||
Centocor Inc. (a subsidiary of Johnson & Johnson; NYSE:JNJ) | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha | Prevention of joint damage in patients with rheumatoid arthritis | Submitted supplemental biologics license application (10/18) |
Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Inc. (the U.S. subsidiary of F. Hoffmann-La Roche; Switzerland) | Tamiflu | Oseltamivir phosphate; anti-viral neuraminidase inhibitor | Influenza A & B | Received marketing approval (10/28) |
North American Vaccine (AMEX: NVX) | Hemophilus influenza type B conjugate vaccine | Influenza B | Received approval for IND application (10/22) | |
Vanguard Medica Group plc (UK;LSE:VGD) | Frovatriptan | 5HT IB/ID antagonist | Migraine | Advised by FDA that further data would be required to support the company's NDA (10/26) |
Notes: | ||||
* Indicates a privately held company. | ||||
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASE = Alberta Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange | ||||
ND = Not Disclosed | ||||
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