Company |
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. |