| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| CANCER | ||||
| BioDelivery Sciences International Inc. (BDSI) | BEMA Fentanyl | A dissolvable polymer formulation of the opioid narcotin fentanyl | Breakthrough cancer pain | Submitted an NDA (10/31) |
| Imclone Systems Inc. (IMCL) | Erbitux (FDA-approved) | Cetuximab | EGFR-expressing metastatic colorectal cancer | FDA approved an sBLA to expand the product labeling to include overall survival data as a single agent following failure of both irinotecan- and oxaliplatin-based regimens (10/3) |
| Genta Inc. (GNTA) | Genasense | Oblimersen sodium injection | Chronic lymphocytic leukemia | Completed its filing of a formal appeal to the FDA regarding the non-approvable letter (10/25) |
| Innovive Pharmaceuticals Inc. (OTC BB:IVPH) | Tamibarotene | A fully synthetic retinoid designed to overcome resistance to all-trans-retinoic acid | Relapsed or refractory acute promy-elocytic leukemia | Received orphan drug designation from the FDA (10/15) |
| Millennium Pharmaceuticals Inc. (MLNM) | Velcade (FDA-approved) | Bortezomib | Refractory multiple myeloma | FDA expanded the label for Velcade to include refractory multiple myeloma patients with impaired kidney function, including those requiring dialysis (10/15) |
| Telik Inc. (TELK) | Telcyta | Canfosfamide HCl, TLK286 | Advanced ovarian cancer and non-small-cell lung cancer | FDA removed the partial hold on clinical trials (10/15) |
| CARDIOVASCULAR | ||||
| Lev Pharmaceuticals Inc. (OTC BB:LEVP) | Cinryze | A C1 inhibitor | Hereditary angioedema | FDA accepted the filing of the BLA (10/2); amended the filing to include data from a pivotal Phase III trial (10/30) |
| CENTRAL NERVOUS SYSTEM | ||||
| Cortex Pharmaceuticals Inc. (AMEX:COR) | CX717 | Ampakine compound | Attention deficit hyperactivity disorder | FDA rejected a proposal for a Phase IIb trial (10/11) |
| Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Toll-like receptor-based therapy | Chronic fatigue syndrome | Filed an NDA (10/11) |
| Knopp Neurosciences Inc.* | KNS-760704 | A small-molecule therapy | Amyotrophic lateral sclerosis | FDA granted orphan drug designation (10/15) |
| Noven Pharmaceuticals Inc. (NOVN) | Stavzor | Delayed release valproic acid capsules | Manic episodes associated with bipolar disorder, multiple seizure types and migraine headaches | FDA issued an approvable letter (10/24) |
| Vernalis plc (UK; LSE:VER) and Endo Pharmaceuticals Inc. (ENDP) | Frova | Frovatriptan | Menstrual migraine | FDA issued a not approvable letter for the sNDA for Frova (10/1) |
| DIABETES | ||||
| Amylin Pharmaceuticals In . (AMLN) | Byetta (FDA-approved) | Exenatide | Type II diabetes | FDA issued a warning that Byetta may be linked to pancreatitis and asked Amylin to include information on the current label (10/16) |
| Amylin Pharmaceuticals Inc. (AMLN) | Symlin (FDA-approved) | Pramlintide acetate | Type II diabetes | FDA issued a non-approvable letter for Symlin use with basal insulin in patients who have not achieved desired glucose control (10/1) |
| INFECTION | ||||
| Gilead Sciences Inc. (GILD) | Viread (FDA-approved) | Tenofovir disoproxil fumarate | Hepatitis B virus | Filed for approval in the U.S. and Europe (10/12) |
| Sequella Inc.* | SQ109 | A diamine anti-TB drug | Tuberculosis | FDA and EMEA granted orphan drug status (10/22) |
| Theravance Inc. (THRX) | Telavancin | A once-daily, injectable antibiotic | Complicated skin and skin structure infections | FDA issued an approvable letter (10/22) |
| MISCELLANEOUS | ||||
| DOR BioPharma Inc. (OTC BB:DORB) | orBec | A steroid-sparing agent | Gastrointestinal graft-vs.-host disease | FDA issued a not approvable letter (10/19) |
| Genzyme Corp. (GENZ) | Renvela | Sevelamer carbonate | To control serum phosphorus in patients with chronic kidney disease on dialysis | FDA granted marketing approval (10/22) |
| MGI Pharma Inc. (MOGN) and Helsinn Healthcare | Aloxi (FDA-approved) | Palonosetron hydrochloride | Postoperative nausea and vomiting | Filed an sNDA (10/30) |
| 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; OTC BB = Over-the-Counter Bulletin Board | ||||
