Company
(Location)

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.