Clinical Intelligence

Etirinotecan Pegol (NKTR-102) passes interim efficacy analysis for phase III study

Wednesday, January 15, 2014 03:51 PM

Nektar Therapeutics has announced that the Independent Data Monitoring Committee (DMC) created to provide safety oversight for the company's pivotal clinical study for etirinotecan pegol (NKTR-102) has recommended continuation of the BEACON phase III trial, based upon the completion of a planned interim efficacy analysis in accordance with the DMC charter. The BEACON trial is evaluating NKTR-102 versus an agent of physician's choice for the treatment of locally recurrent or metastatic breast cancer, with a primary efficacy endpoint of overall survival. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

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WIRB Copernicus Group

AbbVie initiates phase III study of Veliparib (ABT-888) for breast cancer

Wednesday, January 15, 2014 03:25 PM

AbbVie, a global, research-based biopharmaceutical company, has initiated a phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888) when added to carboplatin, a chemotherapy, in women with early-stage, triple-negative breast cancer.  The three-arm trial will compare the addition of veliparib plus carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.

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CRF Health eCOA webinar series

Scioderm initiates phase IIb study of Epidermolysis Bullosa

Tuesday, January 7, 2014 10:30 AM

Scioderm, a privately-held, clinical-stage pharmaceutical company, has initiated a phase IIb study designed to evaluate the efficacy and safety of SD-101, a novel topical therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a rare, genetic connective tissue disorder that typically manifests at birth or early childhood.

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Amgen, UCB release positive phase II data for romosozumab

Tuesday, January 7, 2014 09:00 AM

Amgen and UCB have announced results from a phase II trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD). Published in the New England Journal of Medicine (NEJM), the trial demonstrated that, compared with placebo, romosozumab treatment for 12 months significantly increased BMD at the lumbar spine, total hip and femoral neck. Significant increases also were observed in the first BMD assessment at three months. Moreover, in exploratory analyses, increases observed at the lumbar spine and hip were significantly greater than those observed with current treatments FOSAMAX (alendronate sodium) and FORTEO/FORSTEO (teriparatide).

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FDA approves Tretten to treat rare genetic clotting disorder

Tuesday, January 7, 2014 08:00 AM

The FDA has approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.

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The CenterWatch Monthly, January 2014

Thursday, January 2, 2014 08:00 AM

Will the part-time site landscape finally consolidate?

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iHealth, UCSF, UC Berkeley Lab collaborate on clinical study

Wednesday, December 18, 2013 02:37 PM

iHealth Lab, a provider of mobile personal healthcare products that are connected through the cloud, is collaborating with UC San Francisco and University of California's Berkeley Lab on a pilot study to make arterial endothelial function testing as easy to perform as a simple blood pressure measurement.

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New presurgery combination therapy for triple-negative breast cancer

Tuesday, December 17, 2013 08:13 AM

The I-SPY 2 trial, an innovative, multidrug, phase II breast cancer trial, has yielded positive results with the first drug to complete testing in the trial. Adding the chemotherapy carboplatin and the molecularly targeted drug veliparib to standard presurgery chemotherapy improved outcomes for women with triple-negative breast cancer.

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FDA approves first generic versions of antidepressant drug Cymbalta

Friday, December 13, 2013 01:41 PM

The FDA has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.

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GSK's FluLaval Quadrivalent effective in preventing pediatric seasonal flu

Friday, December 13, 2013 01:29 PM

A peer-reviewed study issued online by the New England Journal of Medicine has reported that GlaxoSmithKline's FluLaval Quadrivalent reduced flu cases among children ages three to eight by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%. This was the first large-scale clinical trial conducted specifically to review the safety and effectiveness of vaccinating children with a four-strain flu vaccine. The randomized, controlled clinical trial included 5,220 children and was one of the pivotal studies leading to the recent approval of FluLaval Quadrivalent by the FDA.

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