Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Targeted Genetics Corp. (TGEN) tgAAC94 A therapy that uses an adeno-associated viral vector to deliver the gene encoding a soluble form of the receptor for tumor necrosis factor-alpha Rheumatoid arthritis FDA permitted the company to resume a Phase I/II trial after an investigation concluded that the treatment did not cause the death of a study participant (11/26)
CANCER
Onyx Pharmaceuticals Inc. (ONXX) and Bayer AG (Germany) Nexavar Sorafenib; systemic therapy; a kinase inhibitor designed to target RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT and FLT-3 Liver cancer FDA approved the product (11/19)
CARDIOVASCULAR
CV Therapeutics Inc. (CVTX) Ranexa (FDA-approved) Ranolazine extended-release tablets Angina; coronary artery disease FDA accepted the firm's sNDA and NDA; the sNDA seeks a first-line angina indication and a reduction in cautionary language; the NDA seeks a labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes (11/20)
Momenta Pharmaceuticals Inc. (MNTA) M-Enoxaparin Generic version of Sanofi-Aventis' blood thinner Lovenox Deep-vein thrombosis and cardiovascular indications FDA rejected an abbreviated NDA (11/6)
CENTRAL NERVOUS SYSTEM
Cephalon Inc. (CEPH) Fentora Fentanyl buccal Breakthrough pain Submitted an sNDA (11/12)
Pozen Inc. (POZN) Trexima A combination of sumatriptan and naproxen sodium Migraine FDA accepted for review its amended response to the Aug. 1 approvable letter (11/1)
Vanda Pharmaceuticals Inc. (VNDA) Iloperidone Atypical antipsychotic Schizophrenia FDA accepted the NDA (11/27)
MISCELLANEOUS
AVI BioPharma Inc. (AVII) AVI-4658 Uses AVI's Exon Skipping Pre-RNA Interference Technology Duchenne muscular dystrophy FDA granted orphan drug designation (11/1)
Discovery Laboratories Inc. (DSCO) Surfaxin An engineered version of natural human lung surfactant containing Discovery Labs' KL-4 peptide To prevent respiratory distress syndrome Submitted its formal response to the FDA's April 2006 approvable letter (11/1); FDA accepted the response (11/16)
Indevus Pharmaceuticals Inc. (IDEV) Nebido A long-acting injectable testosterone preparation Hypogonadism FDA accepted for review the firm's NDA (11/1)
Kiadis Pharma* (the Netherlands) ATIR Selectively eliminates the immune cells that otherwise attack the patient's body Graft-vs.-host disease FDA granted orphan drug status (11/7)
NexMed Inc. (NEXM) Topically applied alprostadil cream Erectile dysfunction FDA accepted for review its NDA (11/20)
Pipex Pharmaceuticals Inc. (AMEX:PP) Coprexa Tetrathiomolybdate Wilson's disease Filed an NDA (11/29)
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