Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Protalex Inc. (Summit, N.J.) |
PRTX-100 |
A highly purified form of Protein A |
Rheumatoid arthritis |
Enrolled the first patients in the fourth cohort of its Phase Ib dose-escalation trial in South Africa |
7/27/12 |
SkyePharma plc (London) |
Flutiform |
Combines the corticosteroid fluticasone propionate with the LABA formoterol fumarate |
Asthma |
European Commission approved it |
7/9/12 |
CANCER | |||||
Astex Pharmaceuticals Inc. (Dublin, Calif.) and Janssen-Cilag International NV (unit of Johnson & Johnson; New Brunswick, N.J.) |
Dacogen |
Decitabine |
Newly diagnosed de novo or secondary acute myeloid leukemia |
CHMP granted a positive opinion recommending approval |
7/23/12 |
Celgene International Sarl (Boudry, Switzerland; subsidiary of Celgene Corp.) |
Istodax |
Romidepsin |
Relapsed or refractory peripheral T-cell lymphoma |
Company is requesting a re-examination of the negative opinion from the CHMP regarding Istodax |
7/23/12 |
Cytheris SA (Paris) |
CYT017 |
Glycosylated recombinant human interleukin-7 |
Progressive multifocal leukoencepha-lopathy |
European Commission granted orphan designation |
7/11/12 |
Seattle Genetics Inc. (Bothell, Wash.) and Millennium: The Takeda Oncology Co. (Cambridge, Mass.) |
Adcetris |
Brentuximab vedotin |
Relapsed or refractory CD30-positive Hodgkin lymphoma and anaplastic large-cell lymphoma |
Received a positive recommendation from the CHMP for antibody-drug conjugate Adcetris |
7/23/12 |
CARDIOVASCULAR | |||||
Theravance Inc. (South San Francisco) and GlaxoSmithKline plc (London) |
Fluticasone furoate/vilanterol |
Once-daily therapy |
Chronic obstructive pulmonary disease and asthma |
Submitted regulatory filings in the European Union |
7/17/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alexza Pharmaceuticals Inc. (Mountain View, Calif.) |
Adasuve |
Staccato loxpaine |
Schizophrenia or bipolar I disorder |
Submitted its responses regarding the Adasuve MAA to the EMA |
7/20/12 |
Arena Pharmaceuticals Inc. (San Diego) |
Lorcaserin |
Lorcaserin hydrochloride |
Obesity |
Filed an MAA with Swiss regulators |
7/13/12 |
Emmaus Medical Inc. (Torrance, Calif.) |
Levogluta-mide |
L-glutamine |
Sickle cell disease |
European Commission granted orphan designation |
7/18/12 |
DIABETES | |||||
Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Vision impairment associated with chronic diabetic macular edema |
France granted marketing authorization; Germany granted marketing authorization |
7/19/12 |
INFECTION | |||||
BioAlliance Pharma SA (Paris) and Sosei Group Corp. (Tokyo) |
SO-1105 |
A once-daily mucoadhesive buccal tablet |
Oropharyn-geal candidiasis |
Completed a Phase I trial in Japan |
7/3/12 |
Optimer Pharmaceuticals Canada Inc. (Toronto) |
Dificid |
Fidaxomicin |
Clostridium difficile infection |
Canadian regulators approved it |
7/6/12 |
MISCELLANEOUS | |||||
Albireo AB (Gothenburg, Sweden) |
A4250 |
Ileal bile acid transporter inhibitor |
Primary biliary cirrhosis, progressive familial intrahepatic cholestasis and Alagille syndrome |
The EMA's Committee for Orphan Medicinal Products issued a positive opinion on an orphan application |
7/25/12 |
Auxilium Pharmaceuticals Inc. (Malvern, Pa.) |
Xiaflex |
Collagenase clostridium histolyticum |
Dupuytren's contracture |
Granted Canadian approval |
7/10/12 |
Hemispherx Biopharma Inc. (Philadelphia) |
Ampligen |
Rintatolimod |
Chronic fatigue syndrome |
Submitted an NDA in Argentina |
7/19/12 |
Ipsen SA (Paris) and Teijin Pharma Ltd. (Tokyo) |
Somatuline |
Lanreotide |
Acromegaly and pituitary gigantism |
Received approval to market it in Japan |
7/2/12 |
Ligand Pharmaceuticals Inc. (San Diego) and Pfizer Inc. (New York) |
BZA/CE |
Bazedoxifene/conjugated estrogens |
Estrogen deficiency symptoms and osteoporosis in women at risk of fracture |
EMA accepted for review the MAA |
7/20/12 |
Medgenics Inc. (Misgav, Israel) |
Epodure Biopumps |
Delivers sustained doses of erythropoietin |
Anemia in end-stage renal disease |
Launched a Phase IIa trial in Israel |
7/18/12 |
Ocular Therapeutix Inc. (Bedford, Mass.) |
OTX-TP1 |
Sustained-release travoprost-loaded punctum plug |
Glaucoma |
Initial results from a trial in Singapore showed intraocular pressure decreased by 5.5 mm Hg three days following insertion and mean IOP was 6.5 mm Hg below baseline after 30 days of treatment |
7/25/12 |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Abbott (Abbott Park, Ill.) |
Amitiza |
Lubiprostone |
Chronic constipation |
Received Japanese approval |
7/6/12 |
uniQure BV (Amsterdam, the Netherlands) |
Glybera |
Gene therapy |
Lipoprotein lipase deficiency |
EMA approved it |
7/23/12 |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
European Commission approved it for people older than 6 with at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene |
7/30/12 |
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. |