Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
DuoCort Pharma AB (Helsingborg, Sweden) |
Plenadren |
Hydrocortisone, modified-release tablet |
Adrenal insufficiency |
European Commission granted approval (11/8) |
Pfizer Inc. (New York) |
Tofacitinib |
An oral JAK inhibitor |
Moderate to severe active rheumatoid arthritis |
EMA validated and began review of tofacitinib (11/22) |
CANCER | ||||
Amgen Inc. (Thousand Oaks, Calif.) |
Vectibix |
Panitumumab; EGFR-targeted cancer drug |
Wild-type KRAS metastatic colorectal cancer |
Gained an expansion to the European label, allowing it to be used as a first-line treatment in combination with FOLFOX and as a second-line treatment in combination with FOLFIRI (11/16) |
BioAlliance Pharma SA (Paris) |
Lauriad |
Clonidine Lauriad |
To prevent radiotherapy-incuded oral mucositits in head and neck cancer patients |
European Commission granted orphan designation (11/3) |
Celgene International Sarl (Boudry, Switzerland) |
Revlimid |
Lenalidomide |
Myelodysplastic syndromes |
Swiss regulators approved it for use in patients with transfusion-dependent anemia due to myelodysplastic syndromes associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities (11/22) |
Celldex Therapeutics Inc. (Needham, Mass.) |
CDX-110 |
Rindopepimut |
Glioblastoma |
EMA granted orphan drug designation (11/1) |
CARDIOVASCULAR | ||||
Amsterdam Molecular Therapeutics NV (Amsterdam, the Netherlands) |
Gene therapy |
Consists of an adeno-associated viral vector containing the human factor IX gene |
Hemophilia B |
Received orphan drug designation from the EMA (11/17) |
Dyax Corp. (Cambridge, Mass.) and Sigma-Tau Group (Rome) |
Kalbitor |
Ecallantide |
Hereditary angioedema |
Companies decided to withdraw the MAA because European regulators indicated the data were not sufficient to prove a positive risk-benefit (11/15) |
Novartis AG (Basel, Switzerland) |
Rasitrio |
Aliskiren, amlodipine and hydrochlorothiazide |
High blood pressure |
Gained European approval (11/29) |
CENTRAL NERVOUS SYSTEM | ||||
Aquinox Pharmaceuticals Inc. (Vancouver, British Columbia |
AQX01125 |
Anti-inflammatory drug |
Asthma |
Began two Phase IIa trials in the UK (11/11) |
Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.) |
Nuedexta |
Dextromethorphan hydrobromide and quinidine sulfate |
Pseudobulbar affect |
Submitted an application to the EMA seeking approval (11/1); EMA accepted the MAA filing (11/18) |
Pfizer Inc. (New York) |
vyndaqel |
Tafamidis |
Transthyretin familial amyloid polyneuropathy |
European Commission approved it to treat adult patients with Stage I symptomatic polyneuropathy (11/18) |
DIABETES | ||||
AstraZeneca plc (London) and Bristol-Myers Squibb Co. (New York) |
Onglyza |
Saxagliptin; DPP-4 inhibitor |
Diabetes |
Gained a European label expansion (11/29) |
Zealand Pharma A/S (Copenhagen, Denmark) |
Lyxumia |
Lixisenatide; once-daily GLP-1 agonist |
Type II diabetes |
A European marketing authorization application has been submitted by its partner Sanofi SA for Lyxumia (11/4) |
INFECTION | ||||
Gilead Sciences Inc. (Foster City, Calif.) |
Tenofovir |
A gel |
HIV |
The National Institute of Allergy and Infectious Diseases requested the Microbicide Trials Network discontinue the use of tenofovir gel as there was no difference when compared to placebo (11/29) |
MISCELLANEOUS | ||||
Alexion Pharmaceuticals Inc. (Chesire, Conn.) |
Soliris |
Eculizumab |
Atypical hemolytic uremic syndrome |
European Commission extended the indication for Soliris to include pediatric and adult patients (11/30) |
Pierre Fabre Medicament (Castres, France) |
Joncia |
Milnacipran |
Fibromyalgia |
Received marketing authorization in Australia (11/22) |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Bayer HealthCare (Leverkusen, Germany) |
Eylea |
Aflibercept |
Wet age-related macular degeneration |
Started a Phase III trial in China (11/29) |
|
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. | ||||