Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
Genzyme Corp. (GENZ) | Campath (FDA-approved) | Alemtuzumab | B-cell chronic lymphocytic leukemia | FDA approved an sBLA and granted regular approval for single-agent Campath to treat B-cell chronic lymphocytic leukemia; it was initially approved in 2001 under accelerated approval regulations (9/20) |
Metabasis Therapeutics Inc. (MBRX) | MB07133 | A HepDirect prodrug of cytarabine monophosphate | Primary liver cancer | FDA granted orphan drug designation (9/10) |
MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) | Aloxi (FDA-approved) | Palonosetron hydrochloride injection | Chemotherapy-induced nausea and vomiting | FDA approved an sNDA to remove a dosing recommendation from the label that limited Aloxi use to once per seven-day intervals (9/4) |
Spectrum Pharmaceuticals Inc. (SPPI) | ISO-Vorin | Levofolinic acid; the pure active isomer of calcium leucovorin | Osteogenic sarcoma | FDA accepted the amendment to the NDA (9/13) |
CARDIOVASCULAR | ||||
CV Therapeutics Inc. (CVTX) | Ranexa (FDA-approved) | Ranolazine extended-release tablets | Chronic angina | Submitted an sNDA to include first-line treatment (9/28) |
Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxsentan sodium | Pulmonary arterial hypertension | In regards to the company's formal dispute resolution request, an FDA reviewer agreed that the data did not provide enough evidence for approval and encouraged the company to conduct another study (9/6) |
GTC Biotherapeutics Inc. (GTCB) | ATryn | A recombinant form of human antithrombin | Hereditary antithrombin | FDA has designated ATryn for fast-track status (9/4) |
The Medicines Co. (MDCO) | Angiomax (FDA-approved) | Bivalirudin; a modified dosing regimen | Acute coronary syndromes | FDA accepted its sNDA (9/24) |
The Medicines Co. (MDCO) | Cleviprex | Clevidipine butyrate injectable emulsion | Acute hypertension | FDA accepted the company's NDA (9/14) |
CENTRAL NERVOUS SYSTEM | ||||
Vanda Pharmaceuticals Inc. (VNDA) | Iloperidone | An atypical antipsychotic that binds to dopamine and serotonin receptors | Schizophrenia | Submitted an NDA to the FDA (9/27) |
INFECTION | ||||
Acambis plc (UK; LSE:ACM) | ACAM2000 | A live, attenuated vaccinia virus smallpox vaccine; a clonal isolate of Dryvax | Smallpox | FDA approved the vaccine for immunization of people at high risk for the infection (9/4) |
Immtech Pharmaceuticals Inc. (AMEX:IMM) | DB289 | Pafuramidine | African trypano-somiasis | FDA granted orphan drug designation (9/19) |
MedImmune Inc. (LSE:MDI) | FluMist | Influenza virus vaccine live, intranasal | Influenza | FDA approved the expanded use of FluMist in children 2 to 5 years of age (9/19) |
MISCELLANEOUS | ||||
NexMed Inc. (NEXM) | Alprostadil | Topically applied cream | Erectile dysfunction | Filed an NDA (9/24) |
NPS Pharmaceuticals Inc. (NPSP) | Preos | Parathyroid hormone (rDNA origin) for injection | Hypoparathyroidism | FDA granted orphan drug designation (9/20) |
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; LSE = London Stock Exchange |