Company* (Symbol)*** |
Product |
Description |
Indication |
Action/Date** |
CANCER | ||||
Algos Pharmaceutical Corp. (ALGO) | MorphiDex |
Enhanced opioid analgesic | Moderate to severe cancer pain |
Received a not-approvable letter (8/2) |
Aronex Pharmaceuticals Inc. (ARNX) |
Atragen |
Liposomal formulation of all trans-retinoic acid |
Acute promeyelocytic leukemia | FDA withdrew invitation to Aronex to discuss its Atragen new drug application (NDA) at the Oncologic Drugs Advisory Committee on Sept. 17 due to deficiencies in the NDA filing (8/5) |
Cell Pathways Inc. (CLPA) |
Aptosyn (formerly Prevatac) | Exisulind; cyclic GMP phosphodiesterase inhibitor | Adenomatous polyposis coli | Submitted NDA (8/26) |
Chiron Corp. (CHIR) | Proleukin (Aldesleukin) |
Recombinant form of T-cell growth factor (interleukin-2) |
Advanced-stage kidney cancer or melanoma | Filed updated survival data (8/17) |
Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham (NYSE:SBH) |
Bexxar (Tositumomab, iodine I 131 tositumomab) | Monoclonal antibody conjugated to a radioisotope |
Relapsed or refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma | FDA requested modifications to biologics license application (BLA) (8/30) |
Diatide Inc. (DITI) and Nycomed Amersham Imaging (NYSE: NYE) | NeoTect |
Technetium Tc 99m depreotide injection; a novel peptide-based imaging agent | Distinction of benign and malignant lung masses | Received marketing approval (8/4) |
Immunomedics Inc. (IMMU) |
CEA-Cide |
Yttrium-90-radiolabeled cancer therapeutic | Ovarian cancer | Received orphan drug status (8/11) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin capsules |
Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation |
Early-stage cutaneous T-cell lymphoma | FDA accepted NDA and and designated it for priority review (8/3) |
CARDIOVASCULAR | ||||
Cypros Pharmaceutical Corp. (AMEX:CYP) |
Cordox |
Cardioprotective drug; small-molecule compound designed to reduce accumulation of lactate; facilitates anaerobic glycolysis | Patients undergoing coronary artery bypass grafting surgery | FDA favorably reviewed Phase III study design, and indicated that no further preclinical studies should be required for the NDA (8/19) |
Genentech Inc. (NYSE:DNA) |
Tenecteplase | Recombinant plasminogen activator | Heart attack |
Submitted BLA (8/2) |
Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham (NYSE:SBH) |
Novastan |
Synthetic molecule (argatro-ban) derived from arginine; acts as direct inhibitor of thrombin | Heparin-induced thrombocytopenia syndrome |
Submitted corrected amendment to NDA (8/23) |
Therapeutic Antibodies Inc. (UK) |
Digitab | Antidote to digoxin poisoning | Digoxin intoxication |
Submitted product license application (PLA) and establishment license application (ELA) (8/9) |
DIABETES | ||||
Ortec International Inc. (ORTC) |
Composite Cultured Skin (CCS) |
Tissue-engineered dressing | Diabetic skin ulcers consisting of two layers of human-derived skin cells (dermal and epidermal) supported within a porous collagen matrix |
Filed application requesting approval to initiate clinical trial (8/24) |
INFECTION | ||||
Avanir Pharmaceuticals (AVNR) | Docosanol | N-docosanol, 10% cream, long-chain fatty acid that interferes with viral entry into cells | Oral-facial herpes | Submitted additional clinical data (8/4) |
Pentose Pharmaceuticals Inc.* |
Inactine technology |
Small-molecule, electrophilic compounds that selectively bind and irreversibly modify nucleic acids, preventing viral replication | Viral inactivation in red blood cells used in transfusions |
Filed investigational new drug application (IND) (8/16) |
MISCELLANEOUS | ||||
Ciba Vision Corp. (a unit of Novartis AG, Switzerland) and QLT Phototherapeutics Inc. (Canada; QLTI) |
Visudyne |
Verteporfin; light-activated drug for photodynamic | Treatment of wet age-related macular degeneration (AMD) in patients with predominately classic sub-foveal choroidal neo-vascularization |
Submitted NDA (8/16) |
Coherent Inc. (COHR) and QLT PhotoTherapeutics Inc. (QLTI) |
Visudyne |
Verteporfin; light-activated drug for photodynamic therapy |
Wet form of AMD |
FDA granted priority review status to joint device/drug application (8/27) |
Duramed Pharmaceuticals Inc. (DRMD) | Cenestin tablets |
Plant derived (soy and yams) synthetic conjugated estrogens | Moderate to severe vasomotor symptoms associated with menopause | Filed NDA supplementary data (8/4) |
InKine Pharmaceutical Co. Inc. (INKP) |
Diacol (formerly INKP-100) |
Sodium phosphate tablets |
Purgative agent for colonic cleansing prior to colonoscopy |
FDA granted waiver of prescription drug application fee (8/25) |
InterMune Pharmaceuticals Inc.* |
Actimmune | Interferon gamma 1-b | Osteopetrosis |
Filed a new BLA for treatment of osteopetrosis (8/23) |
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 |
Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis | FDA expanded product designation for humanitarian uses (8/19) |
V.I. Technologies Inc. (VITX) |
PLAS+SD |
Transfusion plasma product |
For use in transfusions regardless of blood type |
Filed IND amendment to commence trials of a new version of PLAS+SD (8/12) |
* Denotes a privately held company. | ||||
** The dates listed indicate the issue dates of press releases. | ||||
*** Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.N/A = Not Available | ||||
