Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genentech Inc. (South San Francisco; a member of the Roche Group) |
Actemra |
Tocilizumab; a humanized IL-6 receptor-inhibiting monoclonal antibody |
Moderately to severely active rheumatoid arthritis |
FDA expanded the approval indication for patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs |
10/15/12 |
CANCER | |||||
A.P. Pharma Inc. (Redwood City, Calif.) |
APF530 |
A long-acting formulation of granisetron |
Acute- and delayed-onset chemotherapy-induced nausea and vomiting |
Resubmitted its NDA |
10/1/12 |
Ariad Pharmaceuticals Inc. (Cambridge, Mass.) |
Ponatinib |
BCR-ABL inhibitor |
Resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia |
Completed a rolling submission of the NDA; FDA accepted for filing the NDA |
10/1/12; 10/25/12 |
AVEO Oncology Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) |
Tivozanib |
A drug designed to target vascular endothelial growth factor |
Advanced renal cell carcinoma |
Submitted an NDA |
10/1/12 |
Celgene Corp. (Summit, N.J.) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension; albumin-bound |
Advanced or metastatic non-small-cell lung cancer |
FDA approved it for first-line treatment in combination with carboplatin for patients who are not candidates for curative surgery or radiation therapy |
10/15/12 |
Cell Therapeutics Inc. (Seattle) |
Opaxio |
Paclitaxel poliglumex; formerly Xyotax |
Glioblastoma multiforme |
FDA granted orphan drug designation |
10/3/12 |
Cleveland BioLabs Inc. (Buffalo, N.Y.) |
CBL0102 |
Quinacrine |
Hepatocellular carcinoma |
FDA granted orphan drug status |
10/3/12 |
Genentech Inc. (South San Francisco) |
Avastin |
Bevacizumab |
Metastatic colorectal cancer |
FDA accepted its sBLA |
10/17/12 |
Nuvo Research Inc. (Mississauga, Ont.) and Galderma Laboratories LP (Fort Worth, Texas) |
Pliaglis |
Lidocaine/tetracaine cream that forms a pliable peel on the skin when exposed to air |
Dermatological conditions |
FDA approved an sNDA |
10/23/12 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) (acquired through Cephalon Inc. buyout in 2011; original developer was ChemGenex Pharmaceuticals Ltd.) |
Synribo |
Omecataxine mepesuccinate; designed to block certain proteins that promote development of cancer cells |
Chronic myelogenous leukemia |
FDA granted approval |
10/29/12 |
CARDIOVASCULAR | |||||
Actelion Ltd. (Allschwil, Switzerland) |
Opsumit |
Macitentan |
Pulmonary arterial hypertension |
Filed for FDA approval |
10/23/12 |
Aegerion Pharmaceuticals Inc. (Cambridge, Mass.) |
Lomitapide |
A microsomal triglyceride transfer protein inhibitor |
Homozygous familial hypercholesterolemia |
FDA advisory panel voted in favor of approval |
10/18/12 |
Isis Pharmaceuticals Inc. (Carlsbad, Calif.) and Genzyme Corp. (Cambridge, Mass.) |
Kynamro |
Mipomersen, an injected, first-in-class, second-generation antisense apolipoprotein B synthesis inhibitor |
Hozygous familial hypercholesterolemia |
FDA panel voted in favor of approval |
10/19/12 |
NextWave Pharmaceuticals Inc. (Cupertino, Calif.) |
Quillivant XR |
Methylphenidate hydrochloride; extended-release oral suspension |
Attention deficit hyperactivity disorder |
FDA approved it |
10/2/12 |
United Therapeutics Inc. (Silver Spring, Md.) |
Treprostinil |
Oral therapy |
Pulmonary arterial hypertension |
FDA issued a complete response letter |
10/25/12 |
CENTRAL NERVOUS SYSTEM | |||||
MAP Pharmaceuticals Inc. (Mountain View, Calif.) |
Levadex |
Dihydroergot-amine; an orally inhaled migraine drug |
Migraine |
Resubmitted its NDA |
10/17/12 |
Titan Pharmaceuticals Inc. (South San Francisco) |
Probuphine |
A subdermal implant designed to deliver six months of buprenorphine hydrochloride |
Opioid dependence |
Submitted an NDA for the maintenance treatment of opioid dependence in adults |
10/30/12 |
MISCELLANEOUS | |||||
Depomed Inc. (Menlo Park, Calif.) |
Serada |
Extended-release formulation of gabapentin |
Menopausal hot flashes |
FDA accepted for filing the NDA |
10/16/12 |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Gattex |
Teduglutide |
Short bowel syndrome |
FDA committee voted unanimously that the benefits outweighed the risk and the drug should be approved |
10/17/12 |
ThomboGenics NV (Leuven, Belgium) |
Jetrea |
Ocriplasmin |
Symptomatic vitreomacular adhesion |
FDA approved it |
10/19/12 |
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. |