Company (Location)

Product

Description

Indication

Status (Date)#

Cell Therapeutics Inc. (Seattle)

Pixuvri

Pixantrone

Relapsed or refractory aggressive non-Hodgkin's lymphoma

The Office of New Drugs denied an appeal request of the FDA's rejection of the NDA, but the OND clarified conditions for resubmission of the NDA (3/4)

Centocor Ortho Biotech Inc. (Horsham, Pa.)

Trabectedin

A tris tetrahydroisoquinoline alkaloid

Ovarian cancer

Company volunterily withdrew the NDA after the FDA recommended an additional Phase III study (5/2)

Insys Therapeutics Inc. (Phoenix)

Fentanyl SL

A spray

Cancer

FDA accepted the NDA (5/12)

Novartis AG (Basel, Switzerland)

Afinitor

mTOR inhibitor; everolimus

Progressive neuroendocrine tumors of pancreatic origin

FDA approved it for patients with resectable, locally advanced or metastatic disease (5/9)

Pfizer Inc. (New York)

Crizotinib

An oral anaplastic lymphoma kinase inhibitor

ALK-positive advanced non-small-cell lung cancer

NDA was accepted for filing and granted priority review status by the FDA (5/18)

Pfizer Inc. (New York)

Sutent

Sunitinib

Advanced pancreatic neuroendocrine tumors

FDA approved it (5/24)

Plexxikon Inc. (Berkeley, Calif.)

PLX4032

Vemurafenib

Melanoma

Filed marketing applications in the U.S. and Europe (5/12)

Seattle Genetics Inc. (Bothell, Wash.) and Millennium Pharmaceuticals (Cambridge, Mass.)

Brentuximab vedotin

An antibody-drug conjugate

Hodgkin lymphoma and anaplastic large cell lymphoma

FDA accepted two BLAs (5/3)

Spectrum Pharmaceuticals Inc. (Irvine, Calif.)

Fusilev

Levoleucovorin

Advanced metastatic colorectal cancer

Received FDA approval for its use in combination with 5-fluorouracil (5/3)

IntelGenx Corp. (Saint Laurent, Quebec)

CPI-300

Antidepressant

Depression

Submitted its reply to an FDA complete response letter (5/17)

MAP Pharmaceuticals Inc. (Mountain View, Calif.)

Levadex

Orally inhaled drug

Migraine

Submitted an NDA (5/31)

pSivida Corp. (Watertown, Mass.) and Alimera Sciences Inc. (Atlanta)

Iluvien

Fluocinolone acetonide intravitreal insert

Diabetic macular edema

Resubmitted their new drug application, addressing questions raised in a complete resonse letter issued in December 2010 (5/16)

Merck & Co. Inc. (Whitehouse Station, N.Y.)

Victrelis

Boceprevir

Chronic hepatitis C virus

FDA approved its use in combination with peginterferon alfa and ribavirin (5/16)

Tibotec Pharmaceuticals Inc. (Raritan, N.J.; unit of Centocor Ortho Biotech Inc.)

Edurant

Rilpivirine

HIV-1 infection

FDA approved Edurant in combination with other antiretroviral drugs (5/23)

Optimer Pharmaceuticals Inc. (San Diego)

Dificid

Fidaxomicin; macrolide antibiotic

Clostridium difficile-associated diarrhea

FDA approved Dificid (5/31)

Vertex Pharmaceutical Inc. (Cambridge, Mass.)

Incivek

Telaprevir

Hepatitis C virus

FDA approved it to be used in conjunction with the old standard of care, pegylated interferon and ribavirin (5/24)

Mithridion Inc. (Madison, Wis.)

MCD-386CR

An M1-type acetylcholine muscarinic receptor agonist designed to mimic acetylcholine

Progressive supranuclear palsy

FDA granted orphan drug designation (5/10)

Notes:

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.

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

# The date indicated refers to the BioWorld Today issue in which the news item can be found.