| Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
| AUTOIMMUNE | ||||
Acorda Therapeutics Inc. (Hawthorne, N.Y.) |
Fampyra |
Prolonged-release fampridine 10-mg tablets |
Multiple sclerosis |
CHMP recommended conditional marketing authorization (5/23) |
Biogen Idec Inc. (Weston, Mass.) |
Famptra |
Fampridine; 10-mg modified-release tablet |
Multiple sclerosis |
Received approval in Australia for Famptra for the symptomatic improvement of walking ability in patients with MS (5/17) |
Human Genome Sciences Inc. (Rockville, Md.) and GlaxoSmithKline plc (London) |
Benlysta |
Belimumab |
Active autoantibody-positive systemic lupus erythematosus |
CHMP recommended marketing authorization for Benlysta (5/23) |
Savient Pharmaceuticals Inc. (East Brunswick, N.J.) |
Krystexxa |
Pegloticase |
Gout |
EMA accepted and will review the MAA (5/27) |
Simcere Pharmaceutical Group (Nanjing, China) and Shanghai Celgen Bio-Pharmaceutical Co. Ltd. (Shanghai, China) |
Qiangke |
A recombinant human TNF receptor-IgG fusion protein for injection |
Ankylosing spondylitis |
Received new drug registration approval for Qiangke (5/10) |
Savient Pharmaceuticals Inc. (East Brunswick, N.J.) |
Krystexxa |
Pegloticase |
Chronic gout |
Submitted its MAA to the European Medicines Agency (5/6) |
| CANCER | ||||
Cel-Sci Corp. (Vienna, Va.) |
Multikine |
Immunotherapy |
Head and neck cancers |
Taiwan authorities approved enrollment in a Phase III trial, which also is being conducted in Israel (5/4) |
Genta Inc. (Berkeley Heights, N.J.) |
Genasense |
Oblimersen sodium; antisense drug |
Melanoma |
Failed to improve overall survival in the final analysis of the AGENDA Phase III melanoma trial; company is stopping development (5/24) |
Pfizer Inc. (New York) |
Crizotinib |
An oral anaplastic lymphoma kinase inhibitor |
ALK-positive advanced non-small-cell lung cancer |
NDA was filed in Japan (5/18) |
TikoMed AB (Uppsala, Sweden) |
TM-400 |
For mobilizing progenitor cells prior to stem cell transplantation |
Hematological cancers and other diseases |
Granted orphan drug designation in Europe (5/20) |
| DIABETES | ||||
Diamyd Medical AB (Stockholm, Sweden) |
Diamyd |
A recombinant version of glutamic acid decarboxylase |
Type I diabetes |
Missed the primary endpoint of a European Phase III trial (5/10) |
| INFECTION | ||||
Astellas Pharma Europe Ltd. (Staines, UK) and Theravance Inc. (South San Francisco) |
Vibativ |
Telavancin hydrochloride |
Nosocomial pneumonia |
CHMP recommended the granting of marketing authorization (5/23) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
Victrelis |
Boceprevir |
Hepatitis C virus genotype I infection |
CHMP recommended approval (5/23) |
| MISCELLANEOUS | ||||
NeuroHealing Pharmaceuticals Inc. (Newton, Mass.) |
NH001 |
A dopaminergic agonist |
Moderate or severe traumatic brain injury |
European Commission granted orphan drug designation (5/25) |
NeuroSearch A/S (Ballerup, Denmark) |
Huntexil |
Pridopidine; ACR16 |
Huntington's disease |
The EMA told the company it needs to conduct another Phase III trial before it can file for approval (5/25) |
Paladin Labs Inc. (Montreal) |
Oralair |
A sublingual grass pollen immunotherapy |
Allergic rhinitis |
Filed a new drug submission with Health Canada (5/25) |
|
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. | ||||
