Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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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) |
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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) |
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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) |
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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) |
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Progenics Pharmaceuticals Inc. (PGNX) |
MNTX |
Subcutaneous methylnaltrexone |
Opioid-induced constipation |
FDA accepted for review an NDA (5/31) |
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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. |