| Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
| CANCER | ||||
| 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) |
| CENTRAL NERVOUS SYSTEM | ||||
| 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) |
| DIABETES | ||||
| 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) |
| INFECTION | ||||
| 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) |
| MISCELLANEOUS | ||||
| 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. | ||||
