Company |
Product |
Description |
Indication |
Status |
Date |
Alfa Wassermann SpA (Bologna, Italy) and Norgine BV (Amsterdam, the Netherlands) |
Xifaxan |
550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller |
Hepatic encephalopathy |
Received European marketing authorization |
12/10/12 |
Astellas Pharma Inc. (Tokyo) |
Tacrolimus |
Extended-release capsules |
Organ rejection in adult kidney transplant and adult male liver transplant |
FDA accepted for review its NDA |
12/6/12 |
Bristol-Myers Squibb Co. (New York) and Pfizer Inc. (New York) |
Eliquis |
Apixaban |
To prevent recurrent venous thromboembolism; to prevent stroke and embolism in patients with nonvalvular atrial fibrillation |
Phase III data showed that treatment with Eliquis significantly reduced the recurrence of VTE and death from any cause compared to those treated with placebo; the Japanese Ministry of Health, Labor, and Welfare approved Eliquis |
12/11/12 |
Eli Lilly and Co. (Indianapolis) |
Tabalumab |
RA therapy |
Rheumatoid arthritis |
Company is discontinuing one of its three Phase III trials due to a lack of efficacy |
12/14/12 |
GlaxoSmithKline plc (London) |
Fluarix Quadrivalent |
Influenza virus vaccine |
Influenza |
FDA approved it for the immunization of children (3 and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and type B |
12/18/12 |
Iroko Pharmaceuticals LLC (Philadelphia) |
Submicron indomethacin |
Pain relief drug |
Postsurgical acute pain |
Phase III study met its primary endpoint of significant pain relief compared to placebo |
12/10/12 |
Janssen Research & Development LLC (Raritan, N.J.) |
Canagliflozin |
Oral, once-daily selective sodium glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidney |
Type II diabetes |
Submitted an NDA to the FDA for a fixed-dose therapy combining canagliflozin and immediate-release metformin |
12/13/12 |
Janssen Biotech Inc. (Horsham, Pa.) and Janssen Biologics B.V. (Leiden, the Netherlands) |
Stelara |
Ustekinumab |
Active psoriatic arthritis |
Submitted a supplemental BLA to the FDA and a Type II Variation to the EMA requesting approval |
12/7/12 |
Janssen Pharmaceuticals Inc. (unit of New Brunswick, N.J.-based Johnson & Johnson) |
Zytiga |
Oral, once-daily abiraterone acetate |
Metastatic castration-resistant prostate cancer |
FDA approved a broader indication |
12/11/12 |
Johnson & Johnson (New Brunswick, N.J.) |
Zytiga |
Abiraterone acetate |
Prostate cancer |
Phase III data showed that when Zytiga was given to men with no symptoms or mild symptoms before chemotherapy, it doubled the time before tumor progression could be detected by a scan |
12/13/12 |
Johnson & Johnson (New Brunswick, N.J.) |
Galantamine |
Alzheimer's disease therapy |
Alzheimer's disease |
Clinical data showed it gave a significantly lower mortality rate compared to placebo; it also had significantly less cognitive decline after two years compared to the placebo group; the study, with 2,051 subjects, was terminated early due to an imbalance of deaths between the treatment and placebo group, favoring the treatment group |
12/7/12 |
Merck and Co Inc. (Whitehouse Station, N.J.) |
Tredaptive |
Extended-release niacin/laropiprant |
Cardiovascular disease |
Missed its primary endpoint in a trial that enrolled 25,673 patients at high risk for cardiovascular events, and followed them for a median of 3.9 years while they received Tredaptive therapy plus statin therapy or statin therapy alone |
12/21/12 |
Novartis AG (Basel, Switzerland) |
ACZ885 |
Canakinumab |
Systemic juvenile idiopathic arthritis |
A Phase III trial showed that 84% of patients treated with ACZ885 improved by at least 30% compared to 10% of the placebo group, after 15 days of treatment, and that benefit was sustained after 29 days; another Phase III trial showed that 45% of patients receiving ACZ885 who were taking corticosteriods at the beginning of the study were able to reduce the dosage substantially, and one-third of patients discontinued steriods |
12/21/12 |
Novartis AG (Basel, Switzerland) |
Signifor |
Pasireotide injection |
Cushing's disease |
FDA approved it for patients whom pituitary surgery is not an option or has not been curative |
12/18/12 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Ryzodeg |
A soluble formulation of Tresiba, a long-acting basal insulin analogue, and NovoRapid, a rapid-acting insulin |
Diabetes |
The Japanese Ministry of Health, Labour, and Welfare approved it |
12/27/12 |
Otsuka Pharmaceutical Co. Ltd. (Tokyo) and H. Lundbeck A/S (Copenhagen) |
Aripiprazole |
Depot formulation, once-monthly injection |
Schizophrenia |
The European Medicines Agency accepted submission of an MAA |
12/27/12 |
Pfizer Inc. (New York) |
PD-0332991 |
Cancer therapy |
Postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor-1-negative locally advanced or metastatic breast cancer |
Phase II data showed that it in combination with letrozole significantly extended progression-free survival compared to letrozole alone |
12/6/12 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) and H. Lundbeck A/S (Copenhagen, Denmark) |
Vortioxetine |
Proposed brand name: Brintellix |
Major depressive disorder |
FDA accepted for filing the companies' NDA |
12/13/12 |
Tokai Pharmaceuticals Inc. (Cambridge, Mass.) |
TOK-001 |
Galeterone; small molecule |
Castration-resistant prostate cancer |
Treated the first patient in the Phase II ARMOR2 study; up to 196 patients will be enrolled, and the primary endpoints are reduction in prostate-specific antigen levels and safety |
12/14/12 |
Valeant Pharmaceuticals International Inc. (Montreal) |
Halaven |
Eribulin |
Metastatic breast cancer |
Phase III data comparing the drug to capecitabine showed a trend favoring improved overall survival with Halaven in the intention-to-treat population, but the trend did not reach statistical significance |
12/10/12 |
Notes: The date indicated refers to the BioWorld Today issue in which the news item can be found. |