Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Aspreva |
CellCept |
Mycophenolate mofetil; an immunosuppressant |
Pemphigus vulgaris |
The FDA granted orphan designation to the product in that indication, for which a Phase III trial is ongoing (6/6) |
Biogen Idec |
Tysabri |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
The FDA approved supplemental BLA, allowing reintroduction of the drug as monotherapy treatment for relapsing forms of MS (6/5) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
The FDA accepted the sBLA filing that seeks approval for inhibiting structural damage and improving physical function in PA patients (6/21) |
CANCER | ||||
Amgen Inc. |
Panitumumab |
Fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
The FDA accepted BLA filing for review and granted it priority review (6/12) |
Celgene |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Multiple myeloma |
The FDA approved supplemental NDA, for use in combination with dexamethasone to treat MM patients who have received at least one prior therapy (6/29) |
EntreMed Inc. |
Panzem |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Glioblastoma multiforme |
The FDA granted orphan designation to the drug in that indication (6/28) |
Genentech |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic colorectal cancer |
The FDA approved the drug for use with 5-FU- ased chemotherapy for use in second-line treatment (6/20) |
Genitope |
MyVax |
Patient-specific immunotherapy based on the patient's tumor |
Follicular non- Hodgkin's lymphoma |
The FDA granted fast-track designation to the product in that indication, for which Phase III trials are ongoing (6/13) |
Hana |
Zensana |
Ondansetron oral spray; 5-HT3 antagonist |
Chemotherapy- induced nausea and vomiting |
Submitted NDA with FDA, seeking approval in that indication (6/30) |
Hana |
Ropidox-uridine |
Oral thymidine analogue; prodrug for IUdR |
Malignant glioma |
The FDA granted orphan designation to the product in that indication (6/9) |
IDM Pharma |
Bexidem |
Monocyte-derived activated killer cells produced from a patient's white blood cells |
Superficial bladder cancer |
Reached agreement with FDA on SPA for Phase II/III trial, which will enroll about 300 patients (6/13) |
MGI Pharma |
Saforis |
Oral formulation of glutamine in company's delivery system |
Oral mucositis in cancer patients |
The FDA accepted for filing NDA that was submitted in April; the PDUFA date is Oct. 12 (6/12) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Advanced mantle cell lymphoma |
Filed supplemental NDA with FDA seeking approval for treating relapsed or refractory mantle cell lymphoma (6/9) |
Molecular |
Azedra (formerly Ultratrace MIBG) |
Radiopharmaceutical designed to maximize delivery of MIBG molecules |
Neuroendocrine tumors |
The FDA granted fast-track status to the product in that indication (6/22) |
Morphotek |
MORAb-003 |
Monoclonal antibody that targets the folate receptor alpha |
Ovarian cancer |
The FDA granted orphan designation to the product in that indication (6/21) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; oral RAF kinase and VEGF inhibitor |
Metastatic liver cancer |
The FDA granted fast-track designation to the product in that indication, for which Phase III trials are ongoing (6/13) |
Pharmion |
Vidaza (FDA-approved) |
Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions |
Myelodysplastic syndromes |
The FDA accepted for review supplemental NDA seeking approval to allow for I.V. administration (6/13) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Non-small-cell lung cancer |
The FDA granted fast-track designation to product for treating Stage IIIB/IV NSCLC in those who have failed platinum-based therapy (6/1) |
CARDIOVASCULAR | ||||
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The FDA accepted for review the company's complete response to March 24 approvable letter; the PDUFA date is July 24 (6/15) |
Isis |
ISIS 301012 |
Second-generation antisense drug designed to inhibit apoB-100 |
Homozygous familial hypercholesterolemia |
The FDA granted orphan designation to the product for treating HoFH, a rare genetic disorder (6/1) |
TargeGen |
TG100-115 |
Selective PI3-kinase inhibitor |
Myocardial infarction |
The FDA granted fast-track status to the Phase I/II drug for treating acute ST- elevation myocardial infarction (6/29) |
Xechem |
5-HMF |
Five-membered heterocyclic anti-sickling compound |
Sickle cell disease |
The FDA granted orphan designation to the product in that indication (6/6) |
CENTRAL NERVOUS SYSTEM | ||||
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Pseudobulbar affect |
The FDA is extending its review period on the NDA by 90 days; the new PDUFA date is Oct. 30 (6/19) |
Cephalon Inc. |
Fentora |
Fentanyl buccal tablet |
Pain |
The FDA issued an approvable letter on the NDA, which seeks approval for treating breakthrough pain in cancer patients; no additional data are needed (6/30) |
Endo |
Opana ER and Opana tablets |
Extended- and immediate- release formulations of oxymorphone, repsectively |
Pain |
The FDA approved the products for treating moderate to severe pain when use of an opioid is appropriate (6/23) |
Memory |
MEM 3454 |
Nicotinic alpha-7 receptor partial agonist |
Alzheimer's disease |
Initiation of Phase IIa trial was delayed; the FDA was concerned with the potential for impurities in the clinical material to be used in the study (6/1) |
Pozen Inc. |
Trexima |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
The FDA issued an approvable letter calling for additional safety data; new studies could be required (6/9) |
INFECTION | ||||
Elusys |
Anthim (ETI-204) |
Monoclonal antibody that targets the protective antigen component of anthrax |
Anthrax infection |
The FDA granted orphan designation in that indication (6/21) |
InSite Vision |
AzaSite |
Topical solution of azithromycin formulated with DuraSite delivery vehicle |
Bacterial conjunctivitis |
Submitted NDA to the FDA, seeking approval in that indication (6/29) |
MediGene |
Polyphenon E Ointment |
Product from green tea leaves designed to block virus binding to cells |
Genital warts |
The FDA extended review time of the NDA to Oct. 31; the original PDUFA date was July 28 (6/30) |
MISCELLANEOUS | ||||
Adeza |
Gestiva |
Long-acting form of a naturally occurring progesterone |
Prevention of preterm birth |
The FDA granted priority review status to NDA filed in May; the PDUFA date is Oct. 20 (6/5) |
BioMarin |
Orapred ODT |
Prednisolone sodium phosphate tablets; new formulation of Orapred |
Inflammation and asthma indications |
The FDA approved the disintegrating tablet formulation, which will be marketed by Alliant (6/1) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Broncho- pulmonary dysplasia |
The FDA granted the product orphan designation in BPD, also known as chronic lung disease (6/15) |
Genentech |
Lucentis |
Ranibizumab; humanized antibody fragment designed to bind and inhibit VEGF-A |
Wet age-related macular degeneration |
The FDA approved the product for treating wet AMD (6/30) |
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. | ||||
AMEX = American Stock Exchange; FSE = Frankfurt Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange. | ||||
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