Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Ankylosing spondylitis |
The FDA approved the drug for the additional indication of reducing signs and symptoms in those with active AS (7/31) |
CANCER | ||||
Allos |
PDX |
Pralatrexate; small-molecule inhibitor of dihydrofolate reductase |
T-cell lymphoma |
The FDA granted orphan designation to the product in that indication; Phase II trials are being planned (7/26) |
Enzon |
Oncaspar (FDA-approved) |
PEG-enhanced version of the naturally occurring enzyme L-asparaginase |
Acute lymphoblastic leukemia |
The FDA approved expanded use in ALL, for use as part of first-line chemotherapy regimen (7/25) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Hormone-refractory prostate cancer |
Submitted non-clinical section of rolling NDA, which seeks approval in combination with prednisone as a second-line therapy (7/12) |
Intracel |
OncoVAX |
Patient-specific tumor cell vaccine; immunotherapy |
Stage II colon cancer |
The FDA granted SPA for confirmatory pivotal Phase III trial that will include 560 patients (7/19) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib tablets; oral RAF kinase and VEGF inhibitor |
Advanced melanoma |
The FDA granted fast-track designation to the product in that indication, for which the Phase III PRISM combination trial is ongoing (7/20) |
CARDIOVASCULAR | ||||
Corautus |
VEGF-2 |
Vascular endothelial growth factor- in the form of naked plasmid DNA |
Severe angina |
The FDA lifted the hold it placed on Phase IIb GENASIS trial in March; Corautus will analyze data for efficacy on 295 patients already treated (7/13) |
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
The FDA issued second approvable letter, saying one issue remained unresolved; it was not clear if additional trials will be needed (7/24) |
Pharming |
rhC1INH |
Recombinant human C1 inhibitor |
Hereditary angioedema |
The FDA granted fast-track designation to the product in that indication (7/28) |
CENTRAL NERVOUS SYSTEM | ||||
Vernalis plc |
Frova (FDA-approved) |
Frovatriptan; 5HT 1B/1D agonist |
Menstrually related migraine |
Endo submitted supplemental NDA to the FDA, seeking approval in that indication (7/19) |
INFECTION | ||||
Gilead |
Atripla |
Once-daily, single tablet containing BMS' Sustiva and Gilead's Truvada (Viread and Emtriva) |
HIV |
The FDA approved the product for treating HIV infection in adults (7/12) |
MedImmune |
CAIV-T |
Trivalent vaccine; next generation of FluMist; refrigerator-stable formulation |
Influenza |
Submitted supplemental BLA with FDA, seeking approval in children 12 to 59 months of age who do not have a history of wheezing or asthma (7/31) |
MedImmune |
CAIV-T |
Trivalent vaccine; next generation of FluMist; refrigerator-stable formulation |
Influenza |
FDA response letter to BLA asked for clarification and additional information relating to data previously submitted; the filing seeks approval for those 5 to 49 years of age (7/18) |
Nabi Bio- |
Nabi-HB |
Hepatitis B immune globulin; intravenous solution of human antibodies |
Hepatitis B |
An FDA advisory committee recommend approval of product for preventing recurrence of hepatitis B after liver transplant; the BLA was filed in November 2002 (7/13) |
MISCELLANEOUS | ||||
Adeza |
Gestiva |
Long-acting form of a naturally occurring progesterone |
Prevention of preterm birth |
The FDA accepted the NDA for filing (7/6); an FDA advisory panel will review the NDA Aug. 29 (7/18) |
Cellegy |
Cellegesic |
Nitroglycerin ointment |
Anal fissures |
The FDA issued an approvable letter that calls for an additional trial; an amended NDA was resubmitted to the FDA in April 2005 (7/10) |
Critical |
-- |
Controlled-release formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor |
Asthma |
The company filed an NDA with the FDA, seeking approval in that indication (7/31) |
ISTA |
T-Pred |
Fixed combination of tobramycin and prednisolone acetate |
Inflammatory ocular conditions |
Filed NDA with the FDA, seeking approval in cases where a cortico-steroid is indicated and where there are infections or risks of infection (7/6) |
Nastech |
-- |
Intranasal calcitonin-salmon spray |
Osteoporosis |
The FDA cited immunogenecity issues in issuing a not-approvable letter on the abbreviated NDA for the generic product (7/13) |
Shire plc |
Elaprase |
Enzyme-replacement therapy; a form of the lysosomal enzyme iduronate-2-sulfatase |
Hunter syndrome (mucopoly-saccharidosis II) |
The FDA approved the product, the first approved treatment for the rare genetic disease (7/24) |
Valera |
Supprelin-LA |
Implanted product that provides 12- on the delivery of histrelin |
Central precocious puberty |
Submitted NDA seeking approval of the implant for treating the early onset of puberty (7/6) |
|
Y's |
YSPSL |
Molecule resulting from the fusion of P-selectin glycoprotein ligand-1 to human IgG1 |
Prevention of graft dysfunction |
The FDA granted orphan designation to the product for preventing graft dysfunction in kidney transplantation (7/20) |
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. | ||||
FSE = Frankfurt Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||
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