Company* (Symbol) |
Product | Description |
Indication |
Status (Date)** |
CANCER | ||||
Atrix Laboratories Inc. (ATRX) |
Slow-release formulation of leuprolide acetate us-Atrix's Atrigel drug delivery technology |
Prostate cancer |
Submitted IND (2/1) |
|
Cell Pathways Inc. (CLPA) |
Aptosyn |
Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase |
Precancerous colon polyps in patients with familial adenomatous polyposis | Cell Pathways met with FDA 1/25 and affirmed that preparations for commercializing Aptosyn are proceeding as anticipated (2/22) |
Chimeric Therapies Inc.* |
Graft engineering technology that processes donor bone marrow in such a way as to allow only a partial transplant |
Bone marrow transplant in leukemia patients |
Received regulatory clearance to begin two Phase I trials (2/1) | |
EntreMed Inc. (ENMD) |
2-methoxyestradiol (2ME2); orally active, small-molecule angiogenesis inhibitor |
Advanced breast cancer | Received approval to begin clinical testing (Phase I) (2/14) | |
IDT Inc. (subsidiary of Biocontrol Technology Inc. (OTCBB: BICO) and HemoCleanse Inc.* |
Perfusion-Induced Systemic Hyperthermia (PISH) |
Uses ThermoChem technology and disposables to deliver PISH, a therapy in which core body termperature is raised to 42 degrees (107.6 degrees F) |
Non-small-cell lung cancer |
Received FDA and institutional permission to continue trial (2/17) |
Ilex Oncology Inc. (ILXO), Millennium Pharmaceuticals Inc. (MLNM) and Berlex Laboratories (unit of Schering AG; Germany) |
Campath |
Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes | B-cell chronic lymphocytic leukemia | BLA accepted for filing (2/15) |
Ligand Pharmaceuticals Inc. (LGND) |
Targretin gel |
Bexarotene 1%; topical therapy based on synthetic retinoid that selectively activates retinoid X receptors | Cutaneous lesions in stage IA, IB or IIA cutaneous T-cell lymphoma patients who have not tolerated other therapies or who have refractory or persistant disease |
Priority review status granted (2/7)/TD> |
The Liposome Company Inc. | Evacet | Liposomal formulation of doxorubicin |
Metastatic breast cancer |
Met with FDA officials to discuss additional analyses submitted at the end of 1999 with an eye toward resubmission of NDA; original NDA withdrawn 10/99 (2/3) |
Maxim Pharmaceuticals (AMEX:MMP) |
Maxamine | H2 receptor agonist |
Metastatic malignant melanoma | Orphan drug status granted for Maxamine as an adjunct to cytokine therapy (2/25) |
CARDIOVASCULAR | ||||
Biosite Diagnostics Inc. (BSTE) and Scios Inc. (SCIO) |
Triage BNP Test | Test to measure B-type natriuretic peptide | Diagnosis of congestive heart failure |
FDA advisory committee will review product 3/24 (2/9) |
Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (UK; NYSE: SBH) |
Novastan |
Synthetic small molecule (argotroban) derived from arginine; acts as direct inhibitor of thrombin | Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia | Received approvable letter (2/22) |
UroGen Corp. (OTC BB: UROG) |
Factor VIII gene therapy product; delivery system derived from common cold virus | Hemophilia A | IND approved, allowing Phase I trial to start (2/11) |
CENTRAL NERVOUS SYSTEM | ||||
Gliatech Inc. (GLIA) | Adcon-L (FDA-approved) |
Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) |
To inhibit post-operative adhesions involving spinal cord and nerve roots, and to improve patient outcome following lumbar disc surgery | Company resumed distribution of product to hospitals in the U.S.; based on re-inspection conducted by the FDA, the contract manufacturing firm European Medical Contract Manufacturing BV was removed from automatic detention list for the importation of Adcon-L (2/1) |
DIABETES | ||||
Advanced Tissue Sciences Inc. (ATIS) and Smith & Nephew plc (NYSE:SNN) | Dermagraft |
Human tissue-engineered replacement for dermal layer of skin (viable human dermal fibroblasts, derived from foreskins, cultured on bioresorbable scaffold) |
Diabetic foot ulcers | FDA approved application for amendment to IDE application; amendment modifies study inclusion criteria to limit future enrollment to patients with ulcers of greater than six weeks duration (2/29) |
INFECTION | ||||
BioMedicines Inc. * | Genetically engineered version of omega interferon | Hepatitis C virus infection |
Filed IND (2/15) | |
Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP) |
Peg-Intron | Long-acting dosage form of Schering's Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol | Chronic hepatitis C virus infection in adults with compensated liver disease |
BLA accepted for review (2/10) |
Gilead Sciences Inc. (GILD) and Fujisawa Healthcare Inc. (Japan) | AmBisome (FDA-approved) | Liposomal formulation of amphotericin B | Potentially life-threatening fungal infections in neutropenic cancer patients | Supplemental NDA approved; label includes results of trial comparing AmBisome to Abelcet (amphotericine B lipid complex; manufactured by The Liposome Company [LIPO]) (2/10) |
Hemispherx Biopharma Inc. (AMEX:HEB) |
Ampligen | Double-stranded synthetic RNA compound poly I:poly C12U | HIV infection that is becoming resistant to currently approved regimens |
Filed for HIV emergency treatment IND and Phase II and III trials of Ampligen in combination with several Highly Active Antiretroviral Therapy (HAART) regimens (2/17) |
Palatin Technologies Inc. (AMEX:PTN) | LeuTech |
Radiolabeled monoclonal-antibody-based system for imaging infection (product binds specifically to white blood cells) |
Diagnosis of equivocal appendicitis |
BLA accepted for review (2/23) |
MISCELLANEOUS | ||||
Alexion Pharmaceuticals Inc. (ALXN) | 5G1.1 | Anti-inflammatory of the fifth component of the complement cascade (C5) | Dermatomyositis | Filed IND (2/1) |
Amarillo Biosciences Inc. (OTC BB: AMAR) |
Natural human lymphoblastoid interferon-alpha | Behcet's disease | Granted orphan drug status (2/1) | |
ARIAD Pharmaceuticals Inc. (ARIA) | AP1903 |
Small-molecule dimerizer drug for use in conjunction with Ariad's ARGENT (Ariad Regulated Gene Expression Technology); in GvHD product, T cells are harvested from donor peripheral blood prior to bone marrow graft, isolated and genetically engineered to include a gene for an inactive apoptosis protein; T cells are reinfused along with the graft; if patient exhibits a GvHD response, the dimerizer drug, AP1903, is administered to activate the apoptosis protein |
Acute graft-versus-host disease |
Orphan drug status granted; Phase II trial scheduled to begin (2/24) |
InterMune Pharmaceuticals* |
Actimmune | Interferon gamma-1b Injection (FDA-approved) | Severe, malignant osteopetrosis | Cleared for marketing (2/11) |
QLT Phototherapeutics Inc. (Canada; QLTI) and CIBA Vision (eye care unit of Novartis AG; Switzerland) |
Visudyne |
Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, non-thermal 689 nm light |
Wet form of age-related macular degeneration |
Received approvable letter (2/11) |
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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange | ||||
ND = Not disclosed | ||||
BLA = Biologics license application | ||||
IDE = Investigational device exemption | ||||
IND = Investigational new drug application | ||||
NDA = New drug application | ||||
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