Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abbott Laboratories (NYSE:ABT)

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Juvenile rheumatoic arthritis; juvenile idiopathic arthritis

Submitted an sBLA with the FDA and a Type II Variation to the EMEA seeking approval to market Humira for juvenile RA in the U.S. and for juvenile idiopathic arthritis in the European Union (5/7)

CANCER

Cell Therapeutics Inc. (CTIC)

Pixantrone

An anthracenedione

Non-Hodgkin's lymphoma

Gained fast-track designation from the FDA (5/7)

Dendreon Corp. (DNDN)

Provenge

Sipuleucel T; deploys recombinant prostatic acid phosphatase

Prostate cancer

FDA issued an approvable letter asking for more clinical data (5/9); agency said a positive interim or final analysis from an ongoing Phase III will satisfy its request for more data (5/31)

DOR BioPharma Inc. (DORB)

Junovan

Mifamurtide

Osteosarcoma

FDA panel voted 12-2 that IDM has not demonstrated a substantially effective profile for Junovan (5/9)

Gloucester Pharmaceuticals Inc.*

Romidepsin

Histone deacetylase inhibitor

T-cell lymphoma

FDA granted fast-track designation (5/16)

OxiGene Inc. (OXGN)

Zybrestat

Combretastatin-A4 phosphate/CA4P; vascular disrupting agent

Anaplastic thyroid cancer

Reached an agreement with the FDA on an SPA for a Phase II/III pivotal trial (5/31)

Point Therapeutics Inc. (POTP)

Talabostat

A pan-inhibitor of dipeptidyl peptidase enzymes

Non-small-cell lung cancer

FDA placed a hold on the Phase III program after an interim analysis showed neither trial would meet its primary or secondary end-points (5/21)

CARDIOVASCULAR

CV Therapeutics Inc. (CVTX)

Regadenoson

Targets the A2A-adenosine receptor, which is responsible for coronary vaso-dilation

For use as a stress agent in myocardial perfusion imaging tests

Filed an NDA (5/15)

Omrix Bio-pharmaceuticals Inc. (OMRI)

Evicel (FDA-approved)

Liquid fibrin sealant; second generation

For hemostasis in vascular surgery

FDA approved the sBLA (5/15)

CENTRAL NERVOUS SYSTEM

Acorda Therapeutics Inc. (ACOR)

Fampridine-SR

Sustained-release tablet formulation of fampridine (4-aminopyridine)

Multiple sclerosis

Reached agreement with FDA on an SPA for a second Phase III trial (5/22)

Avanir Pharmaceuticals Inc. (AVNR)

FazaClo (FDA-approved)

Clozapine; orally disintegrating tablets

Schizophrenia

Received FDA approval for a new formulation that provides bottle packaging and a 12.5-mg dosage strength, in addition to the 25-mg and 100-mg doses (5/31)

Somaxon Pharmaceuticals Inc. (SOMX)

Silenor

Doxepin; low dose of the approved depression drug

Insomnia

FDA wants results from a 26-week transgenic mouse carcinogenicity study included as part of the initial NDA submission (5/9)

INFECTION

Acambis plc (UK; ACAMF)

ACAM2000

Smallpox vaccine; a clonal isolate of Dryvax that is manufactured using cell-culture technology

Smallpox

An FDA advisory committee voted 11-0 that ACAM2000 is safe and effective for use in high-risk situations (5/17)

Advancis Pharmaceutical Corp. (AVNC)

Amoxicillin Pulsys

A once-a-day presentation of amoxicillin

Pharyngitis/tonsillitis

FDA accepted for filing the NDA (5/22)

Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN)

Ceftobiprole

Broad-spectrum cephalosporin antibiotic

Complicated skin and skin structure infections

New drug application was submitted to the FDA (5/18)

MedImmune Inc. (MEDI)

FluMist (FDA-approved)

Live influenza virus vaccine

Influenza in children between 1 and 5

FDA advisors recommended approval of the expanded label (5/16); FDA said it would withhold final action until issues at the UK bulk manufacturing plant are resolved (5/29)

MISCELLANEOUS

BioMarin Pharmaceutical Inc. (BMRN)

Kuvan (formerly Phenoptin)

Sapropterin dihydrochloride; oral small molecule

Phenylketonuria

Filed an NDA with the FDA (5/24)

Critical Therapeutics Inc. (CRTX) and Dey LP

Zyflo CR (FDA-approved)

Zileuton; a twice-daily leukotriene synthesis inhibitor

Asthma

FDA approved the extended-release Zyflo CR for the prophylaxis and chronic treatment of asthma (5/31)

DUSA Pharmaceuticals Inc. (DUSA)

Levulan

Aminolevulinic acid HCl photodynamic therapy

Esophageal dysplasia

FDA granted orphan drug designation (5/16)

IDM Pharma Inc. (IDMI)

orBec

Oral beclomethasone dipropionate

Gastrointestinal graft-vs.-host disease

FDA panel voted 7-2 that DOR has not demonstrated a substantial benefit with orBec (5/9)

ISTA Pharmaceuticals Inc. (ISTA)

T-Pred

Prednisolone acetate 1% and tobramycin 0.3% ophthalmic suspension

Ocular conditions

Received a not-approvable letter because Phase III trials failed to demonstrate bioequivalence in certain areas (5/4)

MGI Pharma Inc. (MOGN)

Aloxi (FDA-approved)

Palonosetron hydrochloride injection

Postoperative nausea and vomiting

Filed an sNDA (5/7)

Novagali Pharma SA* (France)

Vekacia

A cyclosporine A drug

Vernal kerato-conjunctivitis

FDA granted orphan drug designation (5/25)

Progenics Pharmaceuticals Inc. (PGNX)

MNTX

Subcutaneous methylnaltrexone

Opioid-induced constipation

FDA accepted for review an NDA (5/31)

UCB SA (Belgium; BR:UCB) and Sanofi-Aventis

Xyzal

Levocetirizine dihydrochloride; once-daily antihistamine

Allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria in adults

FDA approved Xyzal for use in adults and children ages 6 and older (5/29)


Notes:

* Privately held.

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

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

BR = Brussels Stock Exchange; NYSE = New York Stock Exchange.

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