Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Biogen Idec Inc. (Weston, Mass.) |
BG-12 |
Dimethyl fumarate |
Multiple sclerosis |
Submitted an NDA (2/29) |
CANCER | ||||
Amgen Inc. (Thousand Oaks, Calif.) |
Xgeva |
Denosumab |
Castration-resistant prostate cancer |
The Oncologic Drugs Advisory Committee voted 12 to 1 that Xgeva did not demonstrate a favorable risk/benefit for the patient population (2/9) |
Arno Therapeutics Inc. (Flemington, N.J.) |
AR-42 |
An orally available, broad-spectrum deacetylation inhibitor of both histone and nonhistone proteins |
Meningioma and schwannoma |
Granted orphan drug designation by the FDA (2/22) |
Astex Pharmaceuticals Inc. (Dublin, Calif.) |
Dacogen |
Decitabine |
Acute myeloid leukemia |
FDA's Oncologic Drugs Advisory Committee voted 10 to 3, with one abstention, that data provided did not support a favorable benefit/risk profile in patients ages 65 and older who are not considered candidates for induction therapy (2/10) |
Can-Fite BioPharma Ltd. (Petah-Tikva, Israel) |
CF102 |
Targets the A3 adenosine receptor |
Hepatocellular carcinoma |
FDA granted orphan drug status (2/24) |
DelMar Pharmaceuticals Ltd. (Vancouver, British Columbia) |
VAL-083 |
A small-molecule chemotherapeutic |
Glioma |
FDA granted orphan drug designation for VAL-083 (2/3) |
Genentech Inc. (South San Francisco) |
Pertuzumab |
A humanized monoclonal antibody designed to inhibit HER2 receptor heterodimerization |
HER2-positive metastatic or locally recurrent, unresectable breast cancer |
FDA accepted the BLA and granted priority review (2/8) |
CARDIOVASCULAR | ||||
Chelsea Therapeutics International Inc. (Charlotte, N.C.) |
Northera |
Droxidopa |
Neurogenic orthostatic hypertension |
FDA committee voted in favor of its approval to treat primary autonomic failure (2/24) |
United Therapeutics Corp. (Silver Spring, Md.) |
Treprostinil diethanolamine |
Sustained-release tablets; oral treprostinil |
Pulmonary arterial hypertension |
FDA accepted its NDA (2/22) |
ViroPharma Inc. (Exton, Pa.) |
Cinryze |
C1 esterase inhibitor |
Hereditary angioedema |
FDA issued a complete response letter regarding manufacturing expansion activities (2/8) |
CENTRAL NERVOUS SYSTEM | ||||
Impax Pharmaceuticals (Hayward, Calif.) |
IPX066 |
An extended-release capsule formulation of carbidopa/levodopa |
Idiopathic Parkinson's disease |
FDA accepted for filing its NDA (2/24) |
NeurogesX Inc. (San Mateo, Calif.) |
Qutenza |
Capsaicin patch |
Neuropathic pain |
A briefing document cited statistical concerns regarding multiplicity and questioned the absence of replicated statistically significant results (2/8); FDA's Anesthetic and Analgesic Drug Products Advisory Committee did not recommend approval (2/13) |
Vivus Inc. (Mountain View, Calif.) |
Qnexa |
Phentermine/topiramate |
Obesity |
FDA committee voted 20 to 2 to support FDA approval in individuals with a body mass index greater than 30 kg/m2 or greater than 27 kg/m2 with weight-related co-morbidities (2/23) |
DIABETES | ||||
Depomed Inc. (Menlo Park, Calif.) and Merck & Co. Inc. (Whitehouse Station, N.J.) |
Janumet XR |
Sitagliptin and metformin extended-release tablets |
Type II diabetes |
FDA approved Janumet XR (2/7) |
INFECTION | ||||
Gilead Sciences Inc. (Foster City, Calif.) |
Truvada |
Emtricitabine/tenofovir disoproxil fumarate |
HIV |
FDA accepted the sNDA and granted a six-month priority review (2/15) |
MISCELLANEOUS | ||||
BioSante Pharmaceuticals Inc. (Lincolnshire, Ill.) and Teva Pharmaceuticals Industries Ltd. (Jerusalem) |
Bio-T-Gel |
A testosterone gel |
Male hypogonadism |
FDA approved it (2/16) |
Columbia Laboratories Inc. (Livingston, N.J.) and Watson Pharmaceuticals Inc. (Parsippany, N.J.) |
Progesterone |
Vaginal gel 8% |
To reduce the risk of preterm birth |
Received a complete response letter because it did not meet the level of statistical significance generally expected to support approval (2/28) |
Corcept Therapeutics Inc. (Menlo Park, Calif.) |
Korlym |
Mifepristone |
Hyperglycemia in patients with Cushing's syndrome |
FDA approved it (2/21) |
Glenveigh Medical LLC (Chattanooga, Tenn.) |
Digoxin immune fab |
Ovine; existing biologic approved for use in cases of digoxin toxicity |
Severe preeclampsia and eclampsia |
FDA granted orphan drug designation (2/15) |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Gattex |
Teduglutide |
Short bowel syndrome |
FDA accepted for review its NDA (2/1) |
Santarus Inc. (San Diego) |
Uceris |
Budesonide; a locally acting corticosteroid |
Mild to moderate active ulcerative colitis |
FDA accepted for filing its NDA (2/16) |
Ultragenyx Pharmaceutical Inc. (Novato, Calif.) |
UX003 |
A recombinant human beta-glucuronidase |
MPS 7, an autosomal recessive lysosomal storage disorder |
FDA granted orphan drug designation (2/29) |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
FDA approved Kalydeco (2/1) |
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. |