Company* |
Product | Description | Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Biogen Idec |
Tysabri |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
The FDA accepted sNDA and designated it for priority review; the sNDA for market re-entry was filed in September (11/17) |
Centocor Inc. |
Remicade |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Plaque psoriasis |
FDA accepted supplemental BLA filing, which seeks approval for treating moderate to severe plaque psoriasis (11/7) |
CANCER | ||||
Celgene Corp. |
Thalomid (FDA-approved) |
Thalidomide |
Multiple myeloma |
The FDA issued an approvable letter on the supplemental NDA, requesting revised labeling and updated safety and some additional patient information (11/15) |
Dendreon |
Provenge |
Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen |
Metastatic prostate cancer |
The FDA granted fast-track status to the product for treating asymptomatic men with metastatic, androgen-independent prostate cancer (11/7) |
Enzon |
Oncaspar (FDA-approved) |
PEG-enhanced version of the naturally occurring enzyme L- asparaginase |
Acute lymphoblastic leukemia |
The FDA approved a labeling change for the pediatric drug, allowing for administration via the intravenous route; it had been approved for intramuscular injection (11/10) |
NeoRx Corp. |
Picoplatin |
Intravenous platinum agent designed to overcome platinum resistance |
Small-cell lung cancer |
The FDA granted orphan designation to the product in that indication (11/10) |
OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced pancreatic cancer |
The FDA approved the drug for use with gemcitabine for treating patients with advanced disease who have not received previous chemotherapy (11/3) |
Seattle |
SGN-40 |
Humanized monoclonal antibody that targets the CD40 antigen |
Chronic lymphocytic leukemia |
The FDA granted the product orphan designation in that indication, for which Phase I/II trials are under way (11/29) |
Solbec |
Coramsine (SBP002) |
Combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum |
Metastatic renal cell carcinoma |
The FDA granted orphan designation to the product in that indication (11/11) |
Viventia |
Proxinium |
Antibody fragment conjugated with a cancer-killing payload |
Recurrent head and neck cancer |
The FDA granted fast-track designation to the drug in recurrent squamous cell carcinoma of the head and neck (11/10) |
CARDIOVASCULAR | ||||
Corautus |
VEGF-2 |
Vascular endothelial growth factor-2 in the form of naked plasmid DNA |
Severe angina |
The FDA granted fast-track designation to the product for treating severe angina associated with cardiovascular disease (11/3) |
CENTRAL NERVOUS SYSTEM | ||||
Labopharm |
-- |
Once-daily formulation of the analgesic tramadol |
Pain |
Submitted NDA to the FDA seeking approval for the management of moderate to moderately severe pain (11/30) |
Orphan |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Narcolepsy |
The product gained FDA approval for treating excessive daytime sleepiness in patients with narcolepsy (11/22) |
Predix |
PRX-00023 |
5-HT1A agonist |
Generalized anxiety disorder |
Reached agreement with FDA on SPA for 310- patient pivotal Phase III trial that began in August (11/30) |
INFECTION | ||||
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
Bacteremia |
The FDA accepted and granted priority-review status to sNDA seeking approval to treat bacteremia with known or suspected endocarditis caused by Staphylococcus aureus (11/21) |
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic pneumonia |
Acute bacterial sinusitis and community-acquired |
Filed supplemental NDA with FDA seeking approval of five-day treatment of the drug for both indications (11/21) |
MISCELLANEOUS | ||||
BioMimetic |
GEM 21S |
Synthetic bone matrix combined with a PDGF, a tissue growth factor |
Periodontal- related bone defects |
The FDA approved the product for treating periodontal bone defects and associated gingival recession (11/21) |
| | ||||
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. | ||||
ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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