Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Biogen Idec Inc.(Weston, Mass.) |
BG-12 |
Dimethyl fumarate |
Multiple sclerosis |
FDA and EMA accepted its marketing applications for review |
5/11/12 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Arcalyst |
Rilonacept; IL-1 blocker |
To prevent gout flares |
FDA committee rejected the supplemental NDA to expand the label, asking for more data |
5/9/12 |
CANCER | |||||
Exelixis Inc. (South San Francisco) |
XL184 |
Cabozantinib |
Progressive, unresectable, locally advanced or metastatic medullary thyroid cancer |
Completed the filings of its rolling NDA |
5/31/12 |
Medivation Inc. (San Francisco) |
MDV3100 |
Enzalutamide |
Prostate cancer |
Submitted an NDA |
5/23/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) and Bayer HealthCare LLC (unit of Bayer AG; Leverkusen, Germany) |
Regorafenib |
Oral multikinase inhibitor |
Metastatic colorectal cancer |
Submitted an NDA |
5/24/12 |
CARDIOVASCULAR | |||||
Aegerion Pharmaceuticals Inc. (Cambridge, Mass.) |
Lomitapide |
Small-molecule microsomal triglyceride transfer protein inhibitor |
To reduce cholesterol in homozygous familial hypercholesterolemia |
FDA accepted the NDA for review |
5/1/12 |
Genzyme Corp. (Cambridge, Mass.; unit of Sanofi SA) |
Kynamro |
Mipomersen sodium |
Homozygous familial hypercholesterolemia |
FDA accepted the NDA |
5/30/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alexza Pharmaceuticals Inc. (Mountain View, Calif.) |
Adasuve |
Loxapine inhalation powder |
Schizophrenia and bipolar disorder |
FDA issued a complete response letter, citing manufacturing deficiencies |
5/7/12 |
Arena Pharmaceuticals Inc. (San Diego) |
Lorqess |
Lorcaserin |
Obesity |
FDA committee voted in favor of approval |
5/11/12 |
Zogenix Inc. (San Diego) |
Zohydro |
Hydrocodone bitartrate extended-release capsules |
Chronic pain |
Submitted an NDA to the FDA |
5/3/12 |
DIABETES | |||||
Andromeda Biotech Ltd. (Yavne, Israel) |
DiaPep277 |
Synthetic peptided derived from the major T-cell epitope of heat-shock protein |
Type I diabetes |
FDA granted orphan drug designation |
5/30/12 |
INFECTION | |||||
BioAlliance Pharma SA (Paris) |
Sitavig |
Acyclovir Lauriad |
Recurrent orofacial herpes |
FDA accepted for review its NDA |
5/30/12 |
Emergent BioSolutions Inc. (Rockville, Md.) |
BioThrax |
Anthrax vaccine adsorbed |
Anthrax |
FDA approved the supplemental BLA |
5/21/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
Truvada |
Emtricitabine/tenofovir disoproxil fumarate |
HIV |
FDA committee voted in favor of approval |
5/11/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
Quad |
Elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate |
HIV |
FDA advisory committee voted in favor of approval |
5/14/12 |
MISCELLANEOUS | |||||
Protalix BioTherapeutics Inc. (Camiel, Israel) and Pfizer Inc. (New York) |
Etelyso |
Taliglucerase alfa; a recombinant version of the hydrolytic human lysosomal enzyme glucocerebrosidase |
Type I Gaucher disease |
FDA approved it |
5/3/12 |
|
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. | |||||