Company* (Symbol)




Status (Date)


Avax Technologies Inc. (AVXT)


Haptenized autologous cell vaccine

Ovarian cancer

FDA granted orphan drug status (9/27)

Cell Pathways Inc. (CLPA)


Small-molecule compound >that augments apoptosis

Familial polyposis

FDA told the company its NDA is not approvable due to deficiencies (9/22)

Cell Therapeutics Inc. (CTIC)


Arsenic trioxide injection


FDA approved the drug to treat patients with a severe form of leukemia whose disease has recurred or who have failed to respond to standard therapy (9/26)

Corixa Corp. (CRXA)


Therapeutic cancer vaccine made of lysed cells from 2 melanoma cell lines with a broad array of melanoma antigens, combined with Detox adjuvant (contains monophosphoryl lipid A and mycobacterial cell-wall skeleton)


Company intends to file a BLA (9/27)

Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham plc (NYSE:SBH)


Radioimmunotherapy involving antibody conjugated to iodine-131

Non-Hodgkin's lymphoma

Company resubmitted BLA (9/18)

IDEC Pharmaceuticals Corp. (IDPH)

Rituxan (FDA-approved)

Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface

Non-Hodgkin's lymphoma

Company received a completed review letter from FDA regarding a supplemental BLA (9/27)

Immunomedics Inc. (IMMU)


Lymphoma therapeutic; epratuzumab

B-cell lymphoma

Company said the FDA hold on clinical trials at the Garden State Cancer Center does not affect LymphoCide or any other products (9/22)

Matrix Pharmaceutical Inc. (MATX)


Cisplatin/epinephrine injectable gel

Metastatic malignant melanoma

FDA granted orphan drug status (9/20)

Maxim Pharmaceuticals Inc. (MAXM)


Histamine dihydrochloride

Advanced-metastatic melanoma

FDA designated Maxamine for priority review; NDA was submitted in July (9/7); company said the Oncology Drugs Advisory Committee will review the drug in December (9/18)

SangStat Medical Corp. (SANG)


Anti-thymocyte globulin (rabbit)

Myelodysplastic syndrome

FDA granted orphan drug designation for Thymoglobulin (9/18)


Alexion Pharmaceuticals Inc. (ALXN) and Procter & Gamble Pharmaceuticals (NYSE:PG)


Monoclonal antibody that inhibits the fifth component of the complement cascade

Cardiopulmonary bypass surgery patients

FDA granted fast-track status and Alexion completed patient enrollment in a 1,000-patient Phase IIb trial (9/7)


Keryx Biopharmaceuticals Inc. (KERX)



Diabetic nephropathy

FDA approved the company's plans to proceed to Phase III trials (9/27)


Abbott Laboratories (NYSE:ABT)


Lopinavir/ritonavir; protease inhibitor


FDA approved Kaletra to treat HIV in adults and children in combination with other anti-retroviral medications (9/15)

Glaxo Wellcome plc (NYSE:GLX)


Zanamivir; neuraminidase inhibitor

Influenza strains A and B

Company submitted application for expanded approval (9/18)

Hemispherx Biopharma Inc. (AMEX:HEB)


Double-stranded synthetic RNA compound poly 1; poly C12U

Drug-resistant HIV

FDA authorized an advanced multicenter study to involve 100 patients (9/5)


Atrix Laboratories Inc. (ATRX)

Atrisorb FreeFlow and doxycycline

Guided tissue regeneration barrier with the antibiotic doxycycline

Tissue regeneration

Atrix received FDA clearance to market Atrisorb FreeFlow guided tissue regeneration barrier with the antibiotic doxycycline; Block Drug Corp. will market the product in the U.S. (9/13)

Genelabs Technologies Inc. (GNLB)


Dehydropieandosterone (DHEA); naturally occurring hormone produced by the adrenal glands

Systemic lupus erythematosus

Company submitted its NDA for marketing approval (9/26)

GenStar Therapeutics (AMEX:GNT)


Gene delivery system derived from the common cold virus

Hemophilia A

Company said its clinical protocol for a Phase I trial was reviewed by the National Institutes of Health Recombinant DNA Advisory Committee and an improved protocol was created (9/29)

Genzyme General (GENZ)


Agalsidase beta; enzyme replacement therapy

Fabry disease

FDA accepted the BLA for Fabrazyme; results from two clinical trials were presented at the International Congress of Inborn Errors of Metabolism (9/19)

Gliatech Inc. (GLIA)


Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

Inhibition of post-surgical scarring and adhesions following back surgery

Company filed a response to the FDA concerning a post approval clinical trial of ADCON-L (9/15)

InKine Pharmaceutical Co. (INKP)


Tablet form (formerly Diacol)

For cleansing the bowel to prepare for colonoscopy

FDA approved Visicol (9/21)

La Jolla Pharmaceutical Co. (LJPC)

LJP 394

Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA

Lupus kidney disease

FDA granted orphan drug designation for LJP 394 (9/6)

Neurochem Inc. (TSE:NRM)


Glycosaminoglycan (GAG) mimetic

Secondary amyloidosis

Company submitted an IND to begin Phase II/III trials (9/12)

Palatin Technologies (ASE:PTN)


Monoclonal antibody

For diagnosing appendicitis

FDA requested additional manufacturing and process validation data for the BLA (9/28)

Visible Genetics Inc. (VGIN)

Trugene HIV-1 Genotyping Kit and OpenGene DNA sequencing system

Designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations and indicate a treatment regimen

To identify genetic mutations in the HIV virus

Company submitted its application to the FDA (9/5)

Vivus Inc. (VVUS)


Topical formulation of alprostadil

Female sexual dysfunction

Company filed an IND to begin clinical testing of Alista (9/21)

Zonagen Inc. (ZONA)


Immediate-release, oral formulation of phentolamine

Erectile dysfunction

FDA told the company that a shorter mechanistic study of brown fat proliferation may be submitted in lieu of a 2-year rodent study in order to lift the partial clinical hold on Vasomax (9/7)


* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; CDNX = Canadian Venture 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

IND = Investigational New Drug Application

BLA = Biologics License Application

NDA = New Drug Application

ND = Not disclosed

PMA = Pre-market Approval Application

SSAHA=Scientific Session of the American Heart Association.

ICAAC=Interscience Conference on Antimicrobial Agents and Chemotherapy.

No Comments