Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Amgen Inc.
(AMGN)

Enbrel (FDA-approved)

Etanercept; tumor necrosis factor inhibitor

Ankylosing spondylitis

An FDA advisory panel unanimously endorsed Enbrel for approval (6/24)

Anika Therapeutics Inc. (ANIK)

Orthovisc

A hyaluronic acid preparation

Osteoarthritis of the knee

Company submitted the third and final module of a premarket approval application to the FDA for Orthovisc (6/3)

CANCER

Axcan Pharma Inc. (Canada; AXCA; TSE:AXP) when light-activated

Photofrin (FDA-approved)

Photodynamic therapy; porfimer sodium; produces toxic oxygen compound

High-grade dysplasia associated with Barrett's esophagus

FDA committee recommended approval (6/27)

Cell Therapeutics Inc. (CTIC)

Xyotax

Polyglutamate paclitaxel

Non-small-cell lung cancer

Company received fast-track designation from the FDA for Xyotax (6/16)

Corixa Corp. (CRXA) and GlaxoSmithKline
plc (UK)

Bexxar

A radioimmunotherapy; tositumomab and iodine- 131 tositumomab

Non-Hodgkin's lymphoma

FDA approved Bexxar (6/30)

Genentech Inc. (NYSE:DNA)

Avastin

Bevacizumab, rhuMAb- VEGF

Metastatic colorectal cancer

FDA designated Avastin as a fast-track development program (6/27)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; anti- sense compound geared toward blocking the pro- duction Bcl-2

Chronic lymphocytic leukemia

FDA designated Genasense as a fast-track product (6/30)

KS Biomedix Holdings plc (UK; LSE:KSB)

KSB303

Radiolabeled antibody

Pancreatic cancer

FDA granted orphan drug status to KSB303 (6/4**)

OxiGene Inc.
(OXGN)

CA4P

Combretastatin A4
Prodrug

Thyroid cancer

FDA granted fast-track designation for CA4P (6/4)

DIABETES

Amylin
Pharmaceuticals
Inc. (AMLN)

Symlin

Pramlintide acetate; an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas

Diabetes

Company submitted an amendment to the FDA after an advisory panel rejected the initial application two years ago (6/17)

INFECTION

MedImmune
Inc.(MEDI)

FluMist

Nasally delivered influenza vaccine

Influenza

FDA approved FluMist (6/17)

Nabi Biopharmaceuticals (NABI)

Nabi-HB (FDA-approved)

Antibody product; intra- venous immune globulin

Hepatitis B

Company received a complete response letter from the FDA for the BLA, which seeks approval for preventing re-infection with hepatitis B in liver transplant recipients who are hepatitis B positive (6/4)

Vicuron Pharmaceuticals Inc. (MICU)

Anidulafungin

Antifungal agent; echinocandin

Esophageal candidiasis

FDA accepted the NDA (6/30)

MISCELLANEOUS

Adprotech Ltd.*
(UK)

APT070

Designed to reduce ischemia reperfusion injury by binding to transplanted tissue and protecting it from attack

To prevent delayed graft function in solid organ transplant

FDA granted orphan drug status to APT070 (6/23)

Genentech Inc. (NYSE:DNA), Tanox Inc. (TNOX) and Novartis Pharma AG (Switzerland)

Xolair

Monoclonal antibody; omalizumab; anti-IgE therapy

Asthma

FDA approved Xolair in adults and adolescents (6/20)

Indevus Pharmaceuticals Inc. (IDEV)

Trospium

Trospium chloride; a muscarinic receptor antagonist

Overactive bladder

FDA accepted for review the NDA (6/30)

Inspire
Pharmaceuticals Inc. (ISPH)

INS365

Diquafosol tetrasodium eye drops in a 2% preservative-free solution

Dry eye disease

Company submitted an NDA (6/27)

Serono Inc.
(Switzerland;
NYSE:SRA)

Serostim

Somatropin (rDNA origin) for injection

Short bowel syndrome

FDA's Gastrointestinal Drugs Advisory Committee rejected the application to market Serostim for short bowel syndrome (6/26)

ZymoGenetics Inc. (ZGEN)

rFactor XIII

Recombinant human Factor XIII

Factor XIII deficiency

FDA granted orphan drug designation and the company initiated a third clinical study (6/4)

Notes:

* Privately held

** Denotes the date the item ran in BioWorld International.

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