Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Almirall SA (Barcelona, Spain) |
Sativex |
Endocannabinoid system modulator |
Spasticity in multiple sclerosis |
Made regulatory submissions to a number of European countries, including Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia (2/8) |
Genzyme (Cambridge, Mass.; unit of Sanofi SA) |
Teriflunomide |
Oral therapy |
Multiple sclerosis |
European Medicines Agency accepted for filing the MAA (2/24) |
CANCER | ||||
Access Pharmaceuticals Inc. (Dallas) and Rhei Pharmaceuticals HK Ltd. (Hong Kong) |
MuGard |
Mucoadhesive oral wound product |
Oral mucositis |
Received marketing approval from Chinese regulators (2/27) |
Cell Therapeutics Inc. (Seattle) |
Pixuvri |
Pixantrone dimaleate |
Non-Hodgkin's B-cell lymphomas |
The CHMP gave a positive opinion on conditional approval (2/21) |
DCPrime BV (Amsterdam, the Netherlands) |
DCP-001 |
A therapeutic vaccine |
Acute myeloid leukemia |
DCPrime received orphan drug designation in Europe for DCP-001 (2/7) |
Plexxikon Inc. (Berkeley, Calif.) |
Zelboraf |
Vemurafenib |
Metastatic melanoma |
European Commission approved Zelboraf as a monotherapy in adults with BRAFV600 mutation-positive unresectable or metastatic melanoma (2/22) |
CARDIOVASCULAR | ||||
CSL Behring LLC (King of Prussia, Pa.; subsidiary of CSL Ltd.) |
rVIIa-FP |
Recombinant fusion protein linking coagulation Factor VIIa with albumin |
Congenital hemophilia |
Received orphan drug designation from the FDA (2/17) |
CENTRAL NERVOUS SYSTEM | ||||
Somaxon Pharmaceuticals Inc. (San Diego) and Paladin Labs Inc. (Montreal) |
Silenor |
Doxepin |
Insomnia |
Filed a new drug submission that has been accepted for review by Health Canada (2/24) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. (San Diego) and Eli Lilly and Co. (Indianapolis) |
Byetta |
Exenatide twice-daily |
Type II diabetes |
CHMP issued a positive opinion for expanded use of Byetta (2/21) |
pSivida Corp. (Watertown, Mass.) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Diabetic macular edema |
UK's Medicines and Healthcare Products Regulatory Agency accepted for review the MAA (2/29) |
MISCELLANEOUS | ||||
Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.) |
CPP-115 |
A GABA aminotransferase inhibitor |
West syndrome |
European Commission granted orphan designation (2/14) |
Clinuvel Pharmaceuticals Ltd. (Melbourne, Australia) |
Scenesse |
Afamelanotide 16-mg implant |
Erythropoietic protoporphyria |
Submitted an MAA to the EMA (2/7) |
Furiex Pharmaceuticals Inc. (Morrisville, N.C.) |
Prilogy |
Dapoxetine 30-mg and 60-mg doses |
Premature ejaculation |
European Commission endorsed a positive opinion (2/2) |
Nymox Pharmaceutical Corp. (Hasbrouck Heights, N.J.) and Recordati SpA (Milan, Italy) |
NX-1207 |
Investigational therapy for BPH |
Benign prostatic hyperplasia |
Started activities aimed at preparing for a European Phase III trial (2/22) |
PregLem SA (Geneva) |
Esmya |
Ulipristal acetate |
Uterin fibroids |
European Commission granted approval (2/28) |
Uluru Inc. (Addison, Texas) |
Altrazeal |
A powder formulation |
Wound healing |
Was approved in Australia (2/24) |
Notes: CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. 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. |