Company* |
Product | Description | Indication |
Status (Date) |
| | ||||
CANCER | ||||
Chemokine |
CTCE-9908 |
Drug targeting cancer via the CXCR4 receptor |
Osteogenic sarcoma |
The FDA granted orphan designation to the drug, which is in Phase I trials (7/19) |
Onyx |
Sorafenib (BAY 43-9006) |
RAF kinase and VEGF inhibitor |
Advanced kidney cancer |
They completed filing of an NDA for that indication (7/11) |
OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced pancreatic cancer |
The FDA accepted for review supplemental NDA for use with gemcitabine; the sNDA was filed in May (7/6) |
Neose |
NE-180 |
Long-acting, glyco- PEGylated erythropoietin |
Chemotherapy- induced anemia |
The FDA placed proposed Phase I trial on hold pending additional manufacturing and preclinical information (7/19) |
Sonus |
Tocosol |
Formulation of paclitaxel using Sonus' delivery system |
Breast cancer |
Reached agreement with FDA on SPA for pivotal Phase III trial that will compare drug to Taxol in 800 patients (7/7) |
CARDIOVASCULAR | ||||
Biopure |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Blood loss in trauma patients |
The FDA put proposed RESUS trial by the Naval Medical Research Center on hold until certain issues are addressed (7/12) |
CV |
Ranexa (ranolazine) |
Partial inhibitor of fatty- acid oxidation |
Chronic angina |
Submitted amendment to the NDA, based on results of ERICA trial; an approvable letter was issued in October 2003 (7/27) |
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The FDA accepted the NDA filing and designated it for standard review; the NDA was filed in May (7/14) |
CENTRAL NERVOUS SYSTEM | ||||
Neurobiological |
Namenda |
Memantine; NMDA receptor antagonist |
Alzheimer's disease |
The FDA issued partner Forest Laboratories Inc. a non-approv- able letter on supplemental NDA to expand the label to include treatment of mild AD (7/25) |
Neurocrine |
Indiplon |
Capsule formulation of a non- enzodiazepine agent that targets the GABA-A receptor |
Insomnia |
The FDA accepted for review the NDA for treatment of insomnia in both adult and elderly patients (7/26) |
INFECTION | ||||
ID Biomedical |
Fluviral |
Influenza virus vaccine |
Influenza |
The FDA granted fast-track designation to the vaccine (7/12) |
Trimeris Inc. |
Fuzeon (FDA-approved) |
HIV fusion inhibitor; enfuvirtide |
HIV |
The FDA accepted the filing of a supplemental NDA seeking to include the Biojector 2000 needle-free injection device in the labeling (7/18) |
Vertex |
640385 (VX-385) |
HIV protease inhibitor |
HIV |
Partner GlaxoSmithKline plc was granted fast-track designation from the FDA; a Phase III trial was about to get under way (7/19) |
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Post-operative |
The FDA issued an approvable letter saying additional proof of efficacy was needed to support the NDA, which was filed in June 2004 (7/22) |
Alizyme plc |
Renzapride |
5-HT4 receptor agonist and an antagonist at 5-HT3 receptors |
Irritable bowel syndrome |
Reached agreement with the FDA under an SPA for pivotal Phase III trial in up to 1,700 women with constipation- redominant IBS (7/7) |
BioDelivery |
Emezine |
Formulation of the approved agent prochlorperazine |
Nausea and vomiting |
The FDA accepted for review the NDA, which was filed in April (7/20) |
Chiron Corp. |
Pulminiq |
Cyclosporine inhalation solution |
For use in patients getting lung transplants |
The FDA said the product was approvable but that an additional trial was needed to confirm efficacy (7/15) |
Genentech |
Nutropin and Nutropin AQ (both FDA- approved) |
Somatropin for injection |
Idiopathic short stature |
The FDA approved supplemental applications for the long-term treatment of ISS (7/7) |
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Pompe disease |
Submitted a BLA to the FDA, seeking approval of the product (7/29) |
InKine |
INKP-102 |
New-generation sodium phosphate purgative tablet |
Bowel cleansing prior to colonoscopy |
The FDA accepted for filing the NDA, which was filed in May (7/26) |
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
The FDA accepted for review the NDA for treating osteoporosis in postmenopausal women; it was filed in May (7/11) |
Santarus Inc. |
Zegerid |
Tablet formulation of the proton pump inhibitor omeprazole |
Gastrointestinal disorders |
The FDA accepted for filing the NDA, which is seeking approval of the chewable tablet formulation for treating heartburn and symptoms of other conditions (7/26) |
| | ||||
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; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||
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