Company
(Location)

Product

Description

Indication

Status

Date

CANCER

Ariad Pharmaceuticals Inc. (Cambridge, Mass.)

Iclusig

Ponatinib; BCR-ABL inhibitor

Chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia

FDA approved it

12/17/12

Cubist Pharmaceuticals Inc. (Lexington, Mass.)

Entereg

Alvimopan

Gastrointestinal recovery after bowel resection with primary anastamosis

Submitted a supplemental NDA

12/26/12

Diffusion Pharmaceuticals LLC (Charlottesville, Va.)

TSC

Trans sodium crocetinate

Metastatic brain cancer

Has been granted orphan drug designation by the FDA

12/13/12

CARDIOVASCULAR

Aegerion Pharmaceuticals Inc. (Cambridge, Mass.)

Juxtapid

Lomitapide capsules, a microsomal triglyceride transfer protein inhibitor

To reduce low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B and non-high-density-lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia

Company won FDA approval as an adjunct to a low-fat diet and other lipid-lowering treatments

12/27/12

Capstone Therapeutics Inc. (Tempe, Ariz.) and LipimetiX Development LLC (a joint venture between Capstone and LipimetiX LLC; Sudbury, Mass.)

AEM-28

An Apo E mimetic peptide drug candidate

Homozygous familial hypercholesterolemia

FDA granted orphan drug designation

12/7/12

Theravance Inc. (South San Francisco) and GlaxoSmithKline plc (London)

UMEC/VI

Once-daily LAMA/LABA combination medicine

Chronic obstructive pulmonary disease

Submitted a regulatory application to the FDA

12/19/12

CENTRAL NERVOUS SYSTEM

Alexza Pharmaceuticals Inc. (Mountain View, Calif.)

Adasuve

Loxapine inhalation powder

Schizophrenia and bipolar disorder

Gained FDA approval eight months after the FDA issued a complete response letter

12/26/12

Zogenix Inc. (San Diego)

Zohydro

Extended-release hydrocodone

Chronic pain

FDA advisory panel voted against recommending approval

12/10/12

INFECTION

Genentech Inc. (South San Francisco)

Tamiflu

Oseltamivir phosphate

Acute, uncomplicated influenza

FDA extended the approval of Tamiflu to include infants 2 weeks of ag e and older

12/26/12

Human Genome Sciences Inc. (Rockville, Md.; a unit of GlaxoSmithKline plc; London)

Raxiba-cumab

Injection; works by neutralizing toxins produced by B. anthracis

Inhalational anthrax

FDA approved it

12/17/12

MISCELLANEOUS

AMAG Pharmaceuticals Inc. (Lexington, Mass.)

Feraheme

Ferumoxytol injection for intravenous use

Iron deficiency anemia in adults who have failed or could not tolerate oral iron treatment

Submitted a supplemental NDA to the FDA

12/27/12

Auxilium Pharmaceuticals Inc. (Malvern, Pa.)

Xiaflex

Collagenase clostridium histolyticum

Peyronie's disease

Its supplemental BLA for Xiaflex has been accepted for filing and granted standard review status by the FDA

12/28/12

Biodel Inc. (Danbury, Conn.)

Glucagon

Therapy for use in the in the congenital hyperinsulinism population

To prevent hypoglycemia

FDA granted orphan drug designation

12/10/12

Ligand Pharmaceuticals Inc. (San Diego) and Pfizer Inc. (New York)

BZA/CE

Bazedoxifene/conjugated estrogens

Moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause

FDA accepted for review an NDA

12/17/12

Milo Biotechnology LLC (Cleveland)

AAV1-FS344

Gene therapy-delivered myostatin inhibitor designed to increase muscle strength

Becker and Duchenne's muscular dystrophy

FDA granted orphan drug designation

12/13/12

Sucampo Pharmaceuticals Inc. (Bethesda, Md.)

Rescula

Unoprostone isopropyl ophthalmic solution

To lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Received FDA approval of a supplemental NDA

12/13/12

NPS Pharmaceuticals Inc. (Bedminister, N.J.)

Gattex

Teduglutide (rDNA origin)

Short bowel syndrome

FDA approved it

12/26/12


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.