Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Savient Pharmaceuticals Inc. (Bridgewater, N.J.) |
Krystexxa |
Pegloticase |
Severe debilitating chronic tophaceous gout |
CHMP issued a positive opinion recommending approval |
10/22/12 |
CANCER | |||||
AB Science SA (Paris) |
Masitinib |
Tyrosine kinase inhibitor |
Pancreatic cancer |
Submitted an MAA in Europe |
10/17/12 |
Astex Pharmaceuticals Inc. (Dublin, Calif.) and Janssen-Cilag International NV (unit of Johnson & Johnson; New Brunswick, N.J.) |
Dacogen |
Decitabine |
Acute myeloid leukemia |
European Commission approved Dacogen |
10/1/12 |
Cytheris SA (Paris) |
CYT017 |
Glycosylated recombinant human interleukin-7 |
Progressive multifocal leukoencephalopathy |
European Commission granted orphan drug status |
10/25/12 |
Dendreon Corp. (Seattle) |
Provenge |
Sipuleucel-T |
Metastatic castrate-resistant prostate cancer |
Started enrolling patients in an open-label European study |
10/1/12 |
CARDIOVASCULAR | |||||
InterMune Inc. (Brisbane, Calif.) |
Esbriet |
Pirfenidone |
Mild to moderate idiopathic pulmonary fibrosis |
Health Canada approved it |
10/4/12 |
ViroPharma Inc. (Exton, Pa.) |
Cinryze |
C1 inhibitor human |
Hereditary angioedema |
Health Canada approved a new drug submission |
10/23/12 |
CENTRAL NERVOUS SYSTEM | |||||
Avid Radio-pharmaceuticals Inc. (Philadelphia) |
Amyvid |
Florbetapir F 18 solution for injection |
For diagnosis of Alzheimer's disease |
Received a positive opinion from the CHMP recommending approval |
10/22/12 |
Vivus Inc. (Mountain View, Calif.) |
Qsiva |
Phentermine/topiramate |
Obesity |
EMA's CHMP recommended against approval based on cardiovascular and central nervous system side effects due to long term use |
10/22/12 |
DIABETES | |||||
Zealand Pharma A/S (Copenhagen, Denmark) and Sanofi SA (Paris) |
Lixisenatide |
Once-daily glucagon-like peptide-1 receptor agonist |
Type II diabetes |
Results from a 28-day study showed it significantly delayed gastric emptying, accompanied by a significant lowering of postprandial glucose throughout the day |
10/3/12 |
INFECTION | |||||
HemispherX Biopharma Inc. (Philadelphia) |
Alferon |
Natural source interferon product; injectable |
Chronic hepatitis C virus |
Filed an amended NDA with Argentinian regulators |
10/2/12 |
MISCELLANEOUS | |||||
Abbott (Abbott Park, Ill.) |
Humira |
Adalimumab |
Moderate-to-severe ulcerative colitis |
Received FDA approval to treat adults when immunosuppressant medicines do not work |
10/1/12 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Eylea |
Aflibercept |
Wet age-related macular degeneration |
Received approval in Japan |
10/1/12 |
|
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. | |||||