Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genzyme Inc. (unit of Sanofi SA; Paris) |
Aubagio |
Teriflunomide |
Relapsing remitting multiple sclerosis |
European Commission granted marketing authorization |
9/3/13 |
Genzyme Corp. (Cambridge, Mass.) |
Lemtrada |
Alemtuzumab |
Relapsing-remitting multiple sclerosis |
Received marketing authorization from the European Commission |
9/18/13 |
CANCER | |||||
Algeta ASA (Oslo, Norway) and Bayer AG (Leverkusen, Germany) |
Xofigo |
Radium Ra 223 dichloride |
Castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases |
Received positive opinion from the European Committee for Medicinal Products for Human Use |
9/23/13 |
Argos Therapeutics Inc. (Durham, N.C.) |
AGS-003 |
A personalized immunotherapy |
Metastatic renal cell carcinoma |
Expanded its Phase III study beyond North America to include sites in Israel, Spain and the Czech Republic |
9/25/13 |
Dendreon Corp. (Seattle) |
Provenge |
Sipuleucel-T |
Asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer |
European Commission granted marketing authorization in the European Union |
9/18/13 |
Halozyme Therapeutics Inc. (San Diego) and Roche AG (Basel, Switzerland) |
Herceptin |
Trastuzumab; subcutaneous formulation |
HER2-positive breast cancer |
European Commission granted marketing authorization |
9/4/13 |
Immunogen Inc. (Waltham, Mass.) |
Kadcyla |
Trastuzumab emtansine; formerly T-DM1 |
HER2-positive, inoperable locally advanced or metastatic breast cancer |
CHMP recommended approval; Japan regulators cleared it for use in inoperable or recurrent HER2-positive breast cancer |
9/23/13 |
Onyx Pharmaceuticals Inc. (South San Francisco) and Bayer Healthcare (Whippany, N.J.) |
Stivarga |
Regorafenib |
Metastatic colorectal cancer |
Won European approval |
9/3/13 |
Orexo AB (Uppsala, Sweden) |
Abstral |
Fentanyl sublingual tablets |
Cancer pain |
Approved in Japan |
9/23/13 |
CARDIOVASCULAR | |||||
Aastrom Biosciences Inc. (Ann Arbor, Mich.) |
Ixmyelocel-T |
A patient-specific multicellular therapy |
Advanced heart failure due to ischemic dilated cardiomyopathy |
Health Canada approved the application for the ongoing Phase IIb trial in Canada |
9/17/13 |
Aegerion Pharmaceuticals Inc. (Cambridge, Mass.) |
Lojuxta |
Lomitapide |
Homozygous familial hyper-cholesterolemia |
Granted orphan drug designation in Japan |
9/10/13 |
Cangene Corp. (Winnipeg, Manitoba) |
Winrho 1500 LQ |
Purified human immunoglobulin |
To prevent Rho immunization after blood transfusions |
Received marketing authorization in Portugal |
9/13/13 |
Cardiome Pharma Corp. (Vancouver, British Columbia) |
Brinavess |
Vernakalant, intravenous |
Atrial fibrillation |
Was approved in Turkey |
9/26/13 |
Glycomimetics Inc. (Gaithersburg, Md.) |
GMI-1070 |
Rivipansel sodium |
Vaso-occlusive crisis in patients with sickle cell disease |
EMA granted orphan drug designation |
9/16/13 |
CENTRAL NERVOUS SYSTEM | |||||
Living Cell Technologies Ltd. (Sydney, Australia) |
Ntcell |
Capsules |
Parkinson’s disease |
Successfully implanted its first patient in a Phase I trial at Auckland City hospital in Australia |
9/24/13 |
DIABETES | |||||
Furiex Pharmaceuticals Inc. (Morrisville, N.C.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Vipidia |
Alogliptin |
Type II diabetes |
European Commission granted marketing authorization |
9/25/13 |
GASTROINTESTINAL | |||||
Ironwood Pharmaceuticals Inc. (Cambridge, Mass.) and Astrazeneca plc (London) |
Linaclotide |
A guanylate cyclase-C agonist |
Irritable bowel syndrome with constipation |
Started a Phase III study in China |
9/11/13 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
Tybost |
Cobicistat |
HIV |
European Commission granted marketing authorization for once-daily Tybost as a boosting agent for HIV protease inhibitors atazanvir and darunavir |
9/27/13 |
Ligand Pharmaceuticals Inc. (San Diego) and Glaxosmithkline plc (London) |
Revolade |
Eltrombopag |
Thrombo-cytopenia in chronic hepatitis C |
European Commission approved an additional indication for Revolade to treat low platelet counts, or thrombocytopenia |
9/25/13 |
Medivir AB (Huddinge, Sweden) |
Simeprevir |
Once-daily combination |
Genotype 1 chronic hepatitis C virus infection |
Japan approved it |
9/30/13 |
MISCELLANEOUS | |||||
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab |
Atypical hemolytic uremic syndrome |
Japanese regulators approved the use of Soliris for pediatric and adult patients |
9/16/13 |
Apricus Biosciences Inc. (San Diego) |
Vitaros |
Topically applied cream formulation of vasodilator alprostadil |
Erectile dysfunction |
Swiss regulators recommended against approval based on certain quality-related issues |
9/3/13 |
Lumena Pharmaceuticals Inc. (San Diego) |
LUM001 |
An inhibitor of the apical sodium-dependent acid transporter |
Alagille syndrome |
Started a global Phase II clinical program with the first person dosed in a UK study |
9/27/13 |
Omeros Corp. (Seattle) |
OMS302 |
Added to standard irrigation solution |
Intraocular lens replacement surgery |
Submitted an MAA to the EMA |
9/11/13 |
Raptor Pharmaceutical Corp. (Novato, Calif.) |
Procysbi |
Gastroresistant hard capsules of cysteamine (as mercaptamine bitartrate) |
Nephropathic cystinosis |
European Commission approved it |
9/13/13 |
Versartis Inc. (Redwood City, Calif.) |
VRS-317 |
Long-acting form of recombinant human growth hormone |
Growth hormone deficiency |
European Commission granted orphan medicinal product designation |
9/16/13 |
|
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. | |||||
