Company* (Symbol)***






Algos Pharmaceutical Corp. (ALGO)


Enhanced opioid analgesic

Moderate to severe cancer pain

Received a not-approvable letter (8/2)

Aronex Pharmaceuticals Inc. (ARNX)


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)


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)


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)


Cypros Pharmaceutical Corp. (AMEX:CYP)


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)


Recombinant plasminogen activator

Heart attack

Submitted BLA (8/2)

Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham (NYSE:SBH)


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)


Antidote to digoxin poisoning

Digoxin intoxication

Submitted product license application (PLA) and establishment license application (ELA) (8/9)


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)


Avanir Pharmaceuticals (AVNR)


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)


Ciba Vision Corp. (a unit of Novartis AG, Switzerland) and QLT Phototherapeutics Inc. (Canada; QLTI)


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)


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.*


Interferon gamma 1-b


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)


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