Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Horizon Pharma Inc. (Deerfield, Ill.) |
Rayos |
Prednisone delayed-release tablets |
Rheumatoid arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease |
FDA approved it |
7/30/12 |
CANCER | |||||
Antisense Pharma GmbH (Regensburg, Germany) |
Trabedersen |
Oncology antisense compound |
Malignant melanoma |
Was granted orphan drug designation from the FDA |
7/25/12 |
Biokine Therapeutics Ltd. (Rehovot, Israel) |
BKT140 |
Used for the mobilization of hematopoietic stem cells from bone marrow |
Hematologic cancers |
Received orphan drug designation from the FDA |
7/25/12 |
Exelixis Inc. (South San Francisco) |
Cabozantinib |
Designed to inhibit MET, VEGFR2 and RET |
Progressive, unresectable, locally advanced or metastatic medullary thyroid cancer |
FDA accepted for filing the NDA |
7/31/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Kyprolis |
Carfilzomib |
Multiple myeloma |
Won accelerated approval as a third-line treatment in patients with relapsed and refractory disease |
7/23/12 |
Senesco Technologies Inc. (Bridgewater, N.J.) |
SNS01-T |
Designed to regulate a growth control switch that induces apoptosis |
Mantle cell lymphoma and diffuse large B-cell lymphoma |
FDA granted orphan drug status |
7/31/12 |
CARDIOVASCULAR | |||||
Amarin Corp. (Dublin, Ireland) |
Vascepa |
Icosapwent ethyl capsules (formerly AMR101) |
Severe hypertriglyceridemia |
FDA approved it as an adjunct to diet to reduce triglyceride levels |
7/27/12 |
Chelsea Therapeutics International Ltd. (Charlotte, N.C.) |
Northera |
Droxidopa |
Neurogenic orthostatic hypotension |
FDA said data from ongoing Study 306B is unlikely to provide sufficient confirmatory evidence to support the refiling of the NDA |
7/5/12 |
Forest Laboratories Inc. (New York) and Almirall SA (Barcelona, Spain) |
Turdorza Pressair |
Aclidinium bromide inhalation powder |
Chronic obstructive pulmonary disease |
FDA approved it |
7/25/12 |
Theravance Inc. (South San Francisco) and GlaxoSmithKline plc (London) |
Fluticasone furoate/vilanterol |
Once-daily therapy |
Chronic obstructive pulmonary disease |
Submitted a regulatory filing in the U.S. |
7/17/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alexza Pharmaceuticals Inc. (Mountain View, Calif.) |
Adasuve |
Staccato loxapine |
Agitation associated with schizophrenia or bipolar disorder I |
FDA accepted its resubmitted Adasuve NDA as a complete, Class 2 response |
7/9/12 |
NuPathe Inc. (Conshohocken, Pa.) |
NP101 |
Migraine patch |
Migraine |
Resubmitted its NDA |
7/18/12 |
Orexo AB (Uppsala, Sweden) |
OX219 |
A sublingual formulation of buprenorphine and naloxone |
Opioid dependency |
FDA advised that two pivotal studies were adequate to support a regulatory submission and no further clinical data were required prior to approval |
7/24/12 |
Salix Pharmaceuticals Ltd. (Raleigh, N.C.) and Progenics Pharmaceuticals Ltd. (Tarrytown, N.Y.) |
Relistor |
Methylnaltrexone bromide |
Opioid-induced constipation in chronic, noncancer pain |
FDA requested additional data with a complete response letter |
7/31/12 |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Amitiza |
Lubiprostone |
Opioid-induced constipation in chronic non-cancer pain patients |
Filed a supplemental NDA |
7/30/12 |
Vivus Inc. (Mountain View, Calif.) |
Qsymia |
Phentermine/topiramate |
Obesity |
FDA approved it |
7/19/12 |
Zogenix Inc. (San Diego) |
Zohydro ER |
Hydrocodone bitartrate extended-release capsules |
Moderate to severe chronic pain |
FDA accepted for review its NDA |
7/17/12 |
DIABETES | |||||
Genentech Inc. (South San Francisco) |
Lucentis |
Ranibuziumab injection |
Diabetic macular edema |
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee gave unanimous support for Lucentis 0.3 mg, recommending it for approval |
7/27/12 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) and Furiex Pharmaceuticals Inc. (Morrisville, N.C.) |
Alogliptin |
Including fixed-dose combination alogliptin and pioglitazone |
Type II diabetes |
Resubmitted NDAs |
7/30/12 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
Cobicistat |
A boosting agent designed to increase blood levels of certain protease inhibitors |
HIV-1 infection |
Submitted an NDA |
7/2/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
Truvada |
Emtricitabine/tenofovir disoproxil fumarate |
HIV |
FDA approved it |
7/17/12 |
Human Genome Sciences Inc. (Rockville, Md.) |
Raxiba-cumab |
Anthrax compound |
Inhalation anthrax |
FDA acknowledge receipt of a BLA |
7/11/12 |
MISCELLANEOUS | |||||
Athersys Inc. (Cleveland) |
MultiStem |
Cell therapy |
Hurler's syndrome |
Was granted orphan designation by the FDA |
7/11/12 |
Swedish Orphan Biovitrum AB (Stockholm, Sweden) |
Kineret |
Anakinra |
Neonatal-onset multisystem inflammatory disease |
Filed an application for Kineret |
7/9/12 |
ThromboGenics NV (Leuven, Belgium) |
Ocriplasmin |
Intravitreal injection |
Symptomatic vitreous macular adhesion |
FDA accepted the filing of its BLA; FDA's Dermatologic and Ophthalmic Drug Advisory Committee recommended it for approval |
7/5/12; 7/27/12 |
|
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. | |||||