Company
(Location)

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.