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 |
CANCER | |||||
AVEO Pharmaceuticals Inc. (Cambridge, Mass.) |
Ficlatuzumab |
A humanized IgG1 antibody |
Non-small-cell lung cancer |
Phase II data of ficlatuzumab and Iressa to Iressa alone in previously untreated Asian subjects showed encouraging signals of activity in subsets of patients based on EGFR mutation status and c-Met expression levels |
5/3/12 |
Cell Therapeutics Inc. (Seattle) |
Pixuvri |
Pixantrone |
Refractory aggressive non-Hodgkin B-cell lymphomas |
Received conditional marketing authorization from the European Commission |
5/11/12 |
Curis Inc. (Lexington, Mass.) and Roche AG (Basel, Switzerland) |
Erivedge |
Vismodegib |
Basal cell carcinoma |
Submitted an application seeking approval in Australia |
5/8/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
Relapsed Hodgkin lymphoma and systemic anaplastic large-cell lymphoma |
Completed its validation period for Adcetris, and Health Canada has accepted its NDA for review |
5/24/12 |
Sunesis Pharmaceuticals Inc. (South San Francisco) |
Vosaroxin |
A first-in-class quinolone derivative |
Acute myeloid leukemia |
European Commission granted orphan drug designation |
5/4/12 |
CARDIOVASCULAR | |||||
Emmaus Medical Inc. (Torrance, Calif.) |
L-glutamine |
Sickle cell disease treatment |
Sickle cell disease |
Received a positive opinion recommending orphan designation by the European Committee for Orphan Medicinal Products |
5/31/12 |
CENTRAL NERVOUS SYSTEM | |||||
Allergan Inc. (Irvine, Calif.) |
Botox |
Botulinum toxin type A |
To prevent headache in adults with chronic migraine |
UK's National Institute for Health and Clinical Excellence recommended it for approval |
5/14/12 |
Genentech Inc. (South San Francisco) |
Crenezumab |
Targets the beta-amyloid pathway |
Alzheimer's disease |
Company is starting a Phase II trial in healthy members of a large extended Colombian family who are likely to develop Alzheimer's due to their genetic history |
5/17/12 |
DIABETES | |||||
pSivida Corp. (Watertown, Mass.) |
Iluvien |
Second-line treatment; a sustained-release intravitreal insert |
Vision impairment associated with chronic diabetic macular edema |
UK granted marketing authorization |
5/8/12 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
Cobicistat |
Pharmaco-enhancing agent to increase blood levels of protease inhibitors |
HIV |
Filed an MAA with the EMA |
5/25/12 |
Ligand Pharmaceuticals Inc. (San Diego) and GlaxoSmithKline plc (London) |
Promacta/Revolade |
Eltrombopag |
Hepatitis C virus infection |
Submitted regulatory applications in the U.S. and Europe |
5/31/12 |
MISCELLANEOUS | |||||
Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.) |
Ampion |
A nonsteroidal anti-inflammatory candidate |
Knee injury |
A planned analysis of the day 84 data of the Australian study showed the change from baseline was statistically significant at both 30 days and 84 days with Ampion, compared to no statistical significance with placebo |
5/1/12 |
Arno Therapeutics Inc. (Flemington, N.J.) |
AR-42 |
A broad-spectrum deacetyelation inhibitor |
Neurofibro-matosis Type 2 |
EMA granted orphan drug status |
5/14/12 |
Halo Therapeutics LLC (Newton, Mass.) |
HT-100 |
Small-molecule formulation of halofuginone |
Duchenne's muscular dystrophy |
European Commission granted orphan designation |
5/4/12 |
Kythera Biopharma-ceuticals Inc. (Los Angeles) |
ATX-101 |
A facial injectable |
To reduce submental fat |
Two European Phase III trials resulted in a statistically significant reduction in submental fat relative to placebo |
5/8/12 |
Ocera Therapeutics Inc. (San Diego) |
Zysa |
Spherical carbon adsorbent |
Diarrhea-predominant irritable bowel syndrome |
Received a CE Mark |
5/21/12 |
Osiris Therapeutics Inc. (Columbia, Md.) |
Prochymal |
Allogeneic stem cell treatment |
Graft-vs.-host disease |
Health Canada approved it |
5/23/12 |
Uluru Inc. (Addison, Texas) |
Altrazeal |
Powder formulation |
Wound healing |
Expanded its 60-patient study to include 500 patients to support the launch of the drug in Australia and New Zealand |
5/4/12 |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
Received a positive opinion from the CHMP for its use in those age 6 and older with at least one copy of the G551D mutation |
5/29/12 |
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. |